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The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

liraglutide

sitagliptin

metformin

liraglutide

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 2 diabetes
Treatment with metformin alone for at least three months
HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive)
Body Mass Index (BMI) less than or equal to 45.0

Exclusion Criteria:

Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors
Treatment with anti-diabetic drugs other than metformin within the last three months
Any serious medical condition
Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg

Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg

Sita -> Sita

Sita -> Sita -> Lira 1.2 mg

Sita -> Sita -> Lira 1.8 mg

Arm Description

Once-daily subcutaneous dose of liraglutide 1.2 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First week for up-titration of liraglutide from 0.6 mg to 1.2 mg. Subjects continued to receive liraglutide 1.2 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).

Once-daily subcutaneous dose of liraglutide 1.8 mg with at least 1500 mg metformin/day (tablets) for 26 weeks. First 2 weeks for up-titration of liraglutide from 0.6 mg to 1.8 mg. Subjects continued to receive liraglutide 1.8 mg once daily in extension period 1 (weeks 26-52) and extension period 2 (weeks 52-78).

Once-daily dose of sitagliptin 100 mg (tablets) with at least 1500 mg metformin/day (tablets) for 26 weeks. Subjects continued to receive 100 mg sitagliptin once daily in extension period 1 (weeks 26-52). In extension period 2 (weeks 52-78), subjects were randomised to liraglutide 1.2 mg + metformin.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78

Secondary Outcome Measures

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26

Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26

Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.

Mean Change From Baseline in Body Weight at Week 26

Calculated as an estimate of the mean change from baseline in body weight at Week 26.

Mean Change From Baseline in Body Weight at Week 52

Calculated as an estimate of the mean change from baseline in body weight at Week 52.

Mean Change in Body Weight From Week 52 to Week 78

Mean change in body weight from Week 52 to Week 78.

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78

Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.

Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78

Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.

Mean Change From Baseline in Beta-cell Function at Week 26

Calculated as an estimate of the mean change from baseline in beta-cell function at Week 26. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Mean Change From Baseline in Beta-cell Function at Week 52

Calculated as an estimate of the mean change from baseline in beta-cell function at Week 52. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Mean Change in Beta-cell Function From Week 52 to Week 78

Mean change in beta-cell function from Week 52 to Week 78. Derived from fasting plasma glucose (FPG) and fasting insulin using the homeostatic model assessment (HOMA) method with the assumption that normal-weight subjects aged under 35 years have a 100% beta-cell function (HOMA-B).

Mean Change From Baseline in Total Cholesterol at Week 26

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.

Mean Change From Baseline in Total Cholesterol at Week 52

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.

Mean Change in Total Cholesterol From Week 52 to Week 78

Mean change in total cholesterol from Week 52 to Week 78

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.

Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78

Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.

Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78

Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.

Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78

Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.

Mean Change From Baseline in Triglycerides (TG) at Week 26

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.

Mean Change From Baseline in Triglycerides (TG) at Week 52

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.

Mean Change in Triglycerides (TG) From Week 52 to Week 78

Mean change in triglycerides (TG) from Week 52 to Week 78.

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.

Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78

Mean change in free fatty acids (FFA) from Week 52 to Week 78.

Mean Change From Baseline in Apolipoprotein B at Week 26

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.

Mean Change From Baseline in Apolipoprotein B at Week 52

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.

Mean Change in Apolipoprotein B From Week 52 to Week 78

Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.

Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26

Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.

Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.

Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.

Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.

Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.

Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Mean Change From Baseline in Adiponectin at Week 26.

Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.

Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.

Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.

Mean Change From Baseline in Waist to Hip Ratio at Week 26.

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Mean Change From Baseline in Waist to Hip Ratio at Week 52

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Mean Change in Waist to Hip Ratio From Week 52 to Week 78

Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Mean Change From Baseline in Waist Circumference at Week 26.

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26

Mean Change From Baseline in Waist Circumference at Week 52

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.

Mean Change in Waist Circumference From Week 52 to Week 78

Mean change in Waist Circumference from Week 52 to Week 78.

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.

Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78

Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.

Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78

Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.

Mean Change From Baseline in Pulse at Week 26

Calculated as an estimate of the mean change from baseline in pulse at Week 26.

Mean Change From Baseline in Pulse at Week 52

Calculated as an estimate of the mean change from baseline in pulse at Week 52.

Mean Change in Pulse From Week 52 to Week 78

Mean change in pulse from Week 52 to Week 78.

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26

The Overall Treatment Satisfaction is a sum of 6 items from the Diabetes Treatment Satisfaction Questionnaire, which is a self-assessment of treatment satisfaction. The scale of each sub-item goes from 0 (lowest satisfaction) to 6 (highest satisfaction) and the overall scale of OTS therefore goes from 0 to 36.

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52

Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78

Hypoglyceamic Episodes, Weeks 0-26

Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

Hypoglyceamic Episodes, Weeks 0-52

Number of hypoglycaemic episodes from Week 0 to Week 52, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52

Hypoglyceamic Episodes, Weeks 0-78

Number of hypoglycaemic episodes from Week 0 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78

Hypoglycaamic Episodes, Weeks 52-78

Number of hypoglycaemic episodes from Week 52 to Week 78, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Full Information

NCT ID

NCT00700817

First Posted

June 18, 2008

Last Updated

January 25, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT00700817

Brief Title

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Official Title

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin in Subjects With Type 2 Diabetes. A 26-week, Randomised, Open-label, Active Comparator, Three-armed, Parallel-group, Multi-centre, Multinational Trial With a 52-week Extension

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

June 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial is conducted in Europe and North America. The aim of this trial is to compare the effect on blood sugar control of liraglutide or sitagliptin, both in combination with metformin, in subjects with type 2 diabetes inadequately controlled with metformin alone. The trial has been extended by 52 weeks. The extension will consist of two 26-week periods: Week 27-52 after randomisation - All subjects will continue receiving sitagliptin or liraglutide at unchanged dose and dosing regimen. Week 53-78 after randomisation Subjects receiving sitagliptin at the end of week 52 after randomisation will discontinue sitagliptin and will be randomised 1:1 to liraglutide 1.2 mg/day or liraglutide 1.8 mg/day. Liraglutide will be initiated at a dose of 0.6 mg/day, and increased to 1.2 mg/day or 1.8 mg/day in weekly intervals. Subjects receiving liraglutide 1.2 mg/day or 1.8 mg/day at the end of week 52 after randomisation will continue the treatment at unchanged dose and dosing regimen. Trial completion is planned for June 2010.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

665 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lira 1.2 mg -> Lira 1.2 mg -> Lira 1.2 mg

Arm Type

Experimental

Arm Description

Arm Title

Lira 1.8 mg -> Lira 1.8 mg -> Lira 1.8 mg

Arm Type

Experimental

Arm Description

Arm Title

Sita -> Sita

Arm Type

Active Comparator

Arm Description

Arm Title

Sita -> Sita -> Lira 1.2 mg

Arm Type

Experimental

Arm Description

Arm Title

Sita -> Sita -> Lira 1.8 mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

1.2 mg once daily, subcutaneous (under the skin) injection

Intervention Type

Drug

Intervention Name(s)

sitagliptin

Intervention Description

Tablets, 100 mg daily

Intervention Type

Drug

Intervention Name(s)

metformin

Intervention Description

Tablets, minimum 1500 mg daily

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

1.8 mg once daily, subcutaneous (under the skin) injection

Primary Outcome Measure Information:

Title

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 26

Description

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 52

Description

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) at Week 78

Description

Calculated as an estimate of the mean change from baseline in glycosylated haemoglobin A1c (HbA1c) at Week 78.

Time Frame

Week 0, Week 78

Title

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) From Week 52 to Week 78

Description

Mean Change in Glycosylated Haemoglobin A1c (HbA1c) from Week 52 to Week 78

Time Frame

Week 52, Week 78

Secondary Outcome Measure Information:

Title

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 26

Description

Calculated as the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 26

Time Frame

Week 0, Week 26

Title

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 52

Description

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 52

Time Frame

Week 0, Week 52

Title

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Description

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the FAS.

Time Frame

Week 0, Week 78

Title

Percentage of Subjects Achieving Treatment Target of HbA1c < 7.0% at Week 78

Description

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c < 7.0% at Week 78. Based on the extension 2 FAS.

Time Frame

Week 0, Week 78

Title

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 26

Description

Calculated as the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 26

Time Frame

Week 0, Week 26

Title

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 52

Description

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 52

Time Frame

Week 0, Week 52

Title

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Description

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the FAS.

Time Frame

Week 0, Week 78

Title

Percentage of Subjects Achieving Treatment Target of HbA1c =< 6.5% at Week 78

Description

Calculated as an estimate of the percentage of subjects achieving treatment target of HbA1c =< 6.5% at Week 78. Based on the extension 2 FAS.

Time Frame

Week 0, Week 78

Title

Mean Change From Baseline in Body Weight at Week 26

Description

Calculated as an estimate of the mean change from baseline in body weight at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Body Weight at Week 52

Description

Calculated as an estimate of the mean change from baseline in body weight at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Body Weight From Week 52 to Week 78

Description

Mean change in body weight from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26

Description

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52

Description

Calculated as an estimate of the mean change from baseline in fasting plasma glucose (FPG) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 78

Description

Calculated as an estimate of the mean change in fasting plasma glucose (FPG) from baseline to Week 78.

Time Frame

Week 0, Week 78

Title

Mean Change in Fasting Plasma Glucose (FPG) From Week 52 to Week 78

Description

Mean change in fasting plasma glucose (FPG) Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Beta-cell Function at Week 26

Description

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Beta-cell Function at Week 52

Description

Time Frame

Week 0, Week 52

Title

Mean Change in Beta-cell Function From Week 52 to Week 78

Description

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Total Cholesterol at Week 26

Description

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Total Cholesterol at Week 52

Description

Calculated as an estimate of the mean change from baseline in total cholesterol at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Total Cholesterol From Week 52 to Week 78

Description

Mean change in total cholesterol from Week 52 to Week 78

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 26

Description

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Low-density Lipoprotein-cholesterol (LDL-C) at Week 52

Description

Calculated as an estimate of the mean change in low-density lipoprotein-cholesterol (LDL-C) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Low-density Lipoprotein-cholesterol (LDL-C) From Week 52 to Week 78

Description

Mean change in low-density lipoprotein-cholesterol (LDL-C) from week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 26

Description

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in High-density Lipoprotein-cholesterol (HDL-C) at Week 52

Description

Calculated as an estimate of the mean change from baseline in high-density lipoprotein-cholesterol (HDL-C) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in High-density Lipoprotein-cholesterol (HDL-C) From Week 52 to Week 78

Description

Mean change in high-density lipoprotein-cholesterol (HDL-C) from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 26

Description

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52

Description

Calculated as an estimate of the change from baseline in very low-density lipoprotein-cholesterol (VLDL-C) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Very Low-density Lipoprotein-cholesterol (VLDL-C) at Week 52 to Week 78

Description

Mean change in very low-density lipoprotein-cholesterol (VLDL-C) from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Triglycerides (TG) at Week 26

Description

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Triglycerides (TG) at Week 52

Description

Calculated as an estimate of the change from baseline in triglycerides (TG) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Triglycerides (TG) From Week 52 to Week 78

Description

Mean change in triglycerides (TG) from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 26

Description

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Free Fatty Acids (FFA) at Week 52

Description

Calculated as an estimate of the change from baseline in free fatty acids (FFA) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Free Fatty Acids (FFA) From Week 52 to Week 78

Description

Mean change in free fatty acids (FFA) from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Apolipoprotein B at Week 26

Description

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Apolipoprotein B at Week 52

Description

Calculated as an estimate of the change from baseline in apolipoprotein B (ApoB) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Apolipoprotein B From Week 52 to Week 78

Description

Mean change in apolipoprotein B (ApoB) from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Highly Sensitive C-reactive Protein (hsCRP) at Week 26

Description

Calculated as an estimate of the mean change from baseline in highly sensitive C-reactive protein (hsCRP) at week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Plasminogen Activator Inhibitor-1 (PAI-1) at Week 26.

Description

Calculated as an estimate of the mean change from baseline in plasminogen activator inhibitor-1 (PAI-1) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Interleukin-6 (IL-6) at Week 26.

Description

Calculated as an estimate of the mean change from baseline in interleukin-6 (IL-6) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Description

Calculated as an estimate of the mean change from baseline in N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Adiponectin at Week 26.

Description

Calculated as an estimate of the mean change from baseline in Adiponectin at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Description

Calculated as an estimate of the mean change from baseline in Tumour Necrosis Factor Alpha (TNF-alpha) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Von Willebrand Factor (vWf) at Week 26.

Description

Calculated as an estimate of the mean change from baseline in von Willebrand Factor (vWf) at Week 26. vWf is a blood glycoprotein involved in haemostasis.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Waist to Hip Ratio at Week 26.

Description

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 26. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Waist to Hip Ratio at Week 52

Description

Calculated as an estimate of the mean change from baseline in Waist to Hip Ratio at Week 52. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Time Frame

Week 0, Week 52

Title

Mean Change in Waist to Hip Ratio From Week 52 to Week 78

Description

Mean change in Waist to Hip Ratio from Week 52 to Week 78. The measure is assessed as the circumference of the waist divided by the circumference of the hip.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Waist Circumference at Week 26.

Description

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 26

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Waist Circumference at Week 52

Description

Calculated as an estimate of the mean change from baseline in Waist Circumference at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Waist Circumference From Week 52 to Week 78

Description

Mean change in Waist Circumference from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 26

Description

Calculated as an estimate of the mean change from baseline in Systolic Blood Pressure (SBP) at Week 26

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Systolic Blood Pressure (SBP) at Week 52

Description

Calculated as an estimate of the mean change from baseline in systolic blood pressure (SBP) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Systolic Blood Pressure (SBP) From Week 52 to Week 78

Description

Mean change in systolic blood pressure (SBP) from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 26

Description

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Diastolic Blood Pressure (DBP) at Week 52

Description

Calculated as an estimate of the mean change from baseline in diastolic blood pressure (DBP) at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Diastolic Blood Pressure (DBP) From Week 52 to Week 78

Description

Mean change in diastolic blood pressure (DBP) from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Pulse at Week 26

Description

Calculated as an estimate of the mean change from baseline in pulse at Week 26.

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Pulse at Week 52

Description

Calculated as an estimate of the mean change from baseline in pulse at Week 52.

Time Frame

Week 0, Week 52

Title

Mean Change in Pulse From Week 52 to Week 78

Description

Mean change in pulse from Week 52 to Week 78.

Time Frame

Week 52, Week 78

Title

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 26

Description

Time Frame

Week 0, Week 26

Title

Mean Change From Baseline in Overall Treatment Satisfaction (OTS) at Week 52

Description

Time Frame

Week 0, Week 52

Title

Mean Change in Overall Treatment Satisfaction (OTS) From Week 52 to Week 78

Description

Time Frame

Week 52, Week 78

Title

Hypoglyceamic Episodes, Weeks 0-26

Description

Time Frame

Weeks 0-26

Title

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-26

Description

Time Frame

Weeks 0-26

Title

Hypoglyceamic Episodes, Weeks 0-52

Description

Time Frame

Weeks 0-52

Title

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-52

Description

Time Frame

Weeks 0-52

Title

Hypoglyceamic Episodes, Weeks 0-78

Description

Time Frame

Weeks 0-78

Title

Hypoglycaemic Episodes (Excluding Outlier Subject), Weeks 0-78

Description

Time Frame

Weeks 0-78

Title

Hypoglycaamic Episodes, Weeks 52-78

Description

Time Frame

Week 52-78

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 diabetes Treatment with metformin alone for at least three months HbA1c (glycosylated haemoglobin A1c) 7.5-10.0% (both inclusive) Body Mass Index (BMI) less than or equal to 45.0 Exclusion Criteria: Previous treatment with insulin, glucagon like peptide-1 (GLP-1) receptor agonists or dipeptidyl peptidase-4 (DPP-4) inhibitors Treatment with anti-diabetic drugs other than metformin within the last three months Any serious medical condition Females who are pregnant, have the intention of becoming pregnant or are breastfeeding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35242

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92646

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90822

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Northridge

State/Province

California

ZIP/Postal Code

91325

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92869

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Poway

State/Province

California

ZIP/Postal Code

92064

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80209

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Panama City

State/Province

Florida

ZIP/Postal Code

32401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

St. Cloud

State/Province

Florida

ZIP/Postal Code

34769

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Athens

State/Province

Georgia

ZIP/Postal Code

30606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dunwoody

State/Province

Georgia

ZIP/Postal Code

30338

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Lithia Springs

State/Province

Georgia

ZIP/Postal Code

30122

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60616

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66204

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70002

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hyattsville

State/Province

Maryland

ZIP/Postal Code

20782

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cleveland

State/Province

Mississippi

ZIP/Postal Code

38732

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

St. Peters

State/Province

Missouri

ZIP/Postal Code

63376

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Berlin

State/Province

New Jersey

ZIP/Postal Code

08009

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Northport

State/Province

New York

ZIP/Postal Code

11768

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Rosedale

State/Province

New York

ZIP/Postal Code

11422

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Pinehurst

State/Province

North Carolina

ZIP/Postal Code

28374

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Tabor City

State/Province

North Carolina

ZIP/Postal Code

28463

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43201

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Cuyahoga Falls

State/Province

Ohio

ZIP/Postal Code

44223

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45406

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45439

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97404

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Norristown

State/Province

Pennsylvania

ZIP/Postal Code

19401

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76014

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Hurst

State/Province

Texas

ZIP/Postal Code

76054

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Ogden

State/Province

Utah

ZIP/Postal Code

84403

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

St. George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23606

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23294

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209

Country

United States

Facility Name

Novo Nordisk Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5A 4L8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6G 2M1

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L4Y 8E3

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1N 6N5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3J 1N2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5C 2T2

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3L9

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1T8

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3J 2V5

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Hamilton

ZIP/Postal Code

L8M 1K7

Country

Canada

Facility Name

Novo Nordisk Investigational Site

City

Karlovac

ZIP/Postal Code

47000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Sisak

ZIP/Postal Code

44000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Slavonski Brod

ZIP/Postal Code

35 000

Country

Croatia

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Former Serbia and Montenegro

Facility Name

Novo Nordisk Investigational Site

City

Nis

ZIP/Postal Code

18000

Country

Former Serbia and Montenegro

Facility Name

Novo Nordisk Investigational Site

City

LA ROCHE-sur-YON cedex 9

ZIP/Postal Code

85295

Country

France

Facility Name

Novo Nordisk Investigational Site

City

LA ROCHELLE cedex

ZIP/Postal Code

17019

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Narbonne

ZIP/Postal Code

11108

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Rennes

ZIP/Postal Code

35056

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Saint Mandé

ZIP/Postal Code

94160

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Strasbourg

ZIP/Postal Code

67000

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Venissieux

ZIP/Postal Code

69200

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Bad Lauterberg

ZIP/Postal Code

37431

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Dormagen

ZIP/Postal Code

41539

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Frankfurt

ZIP/Postal Code

60388

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Herrenberg

ZIP/Postal Code

71083

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Kassel

ZIP/Postal Code

34117

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Riesa

ZIP/Postal Code

01587

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Schönebeck

ZIP/Postal Code

39218

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Ulm

ZIP/Postal Code

89073

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Völklingen

ZIP/Postal Code

66333

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Wangen

ZIP/Postal Code

88239

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Dublin 9

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 15

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 4

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 7

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Dublin

ZIP/Postal Code

DUBLIN 8

Country

Ireland

Facility Name

Novo Nordisk Investigational Site

City

Catania

ZIP/Postal Code

95124

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Lucca

ZIP/Postal Code

55100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Messina

ZIP/Postal Code

98123

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Olbia

ZIP/Postal Code

07026

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Palermo

ZIP/Postal Code

90123

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Roma

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Siena

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Trieste

ZIP/Postal Code

34148

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Almere

ZIP/Postal Code

1311RL

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Apeldoorn

ZIP/Postal Code

7334 DZ

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Beek

ZIP/Postal Code

6191JW

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Groningen

ZIP/Postal Code

9728 NT

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Hengelo

ZIP/Postal Code

7555 DL

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Roelofarendsveen

ZIP/Postal Code

2371 RB

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Stadskanaal

ZIP/Postal Code

9501 EH

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Zevenaar

ZIP/Postal Code

6903 ZN

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Zoetermeer

ZIP/Postal Code

2725 NA

Country

Netherlands

Facility Name

Novo Nordisk Investigational Site

City

Caquas

ZIP/Postal Code

00725

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Guaynabo

ZIP/Postal Code

00968

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Manati

ZIP/Postal Code

00674

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Rio Piedras

ZIP/Postal Code

00921

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Trujillo Alto

ZIP/Postal Code

00976

Country

Puerto Rico

Facility Name

Novo Nordisk Investigational Site

City

Oradea

State/Province

Bihor

ZIP/Postal Code

410469

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Craiova

State/Province

Dolj

ZIP/Postal Code

200642

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Bucharest

ZIP/Postal Code

020614

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Timisoara

ZIP/Postal Code

300736

Country

Romania

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

811 08

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

82102

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Bratislava

ZIP/Postal Code

851 05

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Nitra

ZIP/Postal Code

94 911

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Nove Zamky

ZIP/Postal Code

940 59

Country

Slovakia

Facility Name

Novo Nordisk Investigational Site

City

Ljubljana

ZIP/Postal Code

1525

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Novo mesto

ZIP/Postal Code

8000

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Trbovlje

ZIP/Postal Code

1420

Country

Slovenia

Facility Name

Novo Nordisk Investigational Site

City

Alzira

ZIP/Postal Code

46600

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Getafe

ZIP/Postal Code

28905

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Oviedo

ZIP/Postal Code

33006

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07010

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Palma de Mallorca

ZIP/Postal Code

07014

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Puerto del Rosario

ZIP/Postal Code

35600

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Aberdeen

ZIP/Postal Code

AB25 1LD

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Abergavenny

ZIP/Postal Code

NP7 7EG

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Aldershot

ZIP/Postal Code

GU12 5BA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Ayr

ZIP/Postal Code

KA6 6DX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Chippenham

ZIP/Postal Code

SN15 2SB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Coventry

ZIP/Postal Code

CV6 2FL

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Edgbaston, Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Glasgow

ZIP/Postal Code

G45 9AW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Letchworth

ZIP/Postal Code

SG6 4UB

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Maidstone

ZIP/Postal Code

ME16 9QQ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Oxford

ZIP/Postal Code

OX3 7LE

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Sheffield

ZIP/Postal Code

S5 7AU

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Swansea

ZIP/Postal Code

SA6 6NL

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

20417856

Citation

Pratley RE, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Thomsen AB, Sondergaard RE, Davies M; 1860-LIRA-DPP-4 Study Group. Liraglutide versus sitagliptin for patients with type 2 diabetes who did not have adequate glycaemic control with metformin: a 26-week, randomised, parallel-group, open-label trial. Lancet. 2010 Apr 24;375(9724):1447-56. doi: 10.1016/S0140-6736(10)60307-8. Erratum In: Lancet. 2010 Jul 24;376(9737):234.

Results Reference

result

PubMed Identifier

21309842

Citation

Davies M, Pratley R, Hammer M, Thomsen AB, Cuddihy R. Liraglutide improves treatment satisfaction in people with Type 2 diabetes compared with sitagliptin, each as an add on to metformin. Diabet Med. 2011 Mar;28(3):333-7. doi: 10.1111/j.1464-5491.2010.03074.x.

Results Reference

result

PubMed Identifier

21355967

Citation

Pratley R, Nauck M, Bailey T, Montanya E, Cuddihy R, Filetti S, Garber A, Thomsen AB, Hartvig H, Davies M; 1860-LIRA-DPP-4 Study Group. One year of liraglutide treatment offers sustained and more effective glycaemic control and weight reduction compared with sitagliptin, both in combination with metformin, in patients with type 2 diabetes: a randomised, parallel-group, open-label trial. Int J Clin Pract. 2011 Apr;65(4):397-407. doi: 10.1111/j.1742-1241.2011.02656.x. Epub 2011 Mar 1.

Results Reference

result

PubMed Identifier

22193143

Citation

Henry RR, Buse JB, Sesti G, Davies MJ, Jensen KH, Brett J, Pratley RE. Efficacy of antihyperglycemic therapies and the influence of baseline hemoglobin A(1C): a meta-analysis of the liraglutide development program. Endocr Pract. 2011 Nov-Dec;17(6):906-13. doi: 10.4158/ep.17.6.906.

Results Reference

result

PubMed Identifier

21883806

Citation

Zinman B, Schmidt WE, Moses A, Lund N, Gough S. Achieving a clinically relevant composite outcome of an HbA1c of <7% without weight gain or hypoglycaemia in type 2 diabetes: a meta-analysis of the liraglutide clinical trial programme. Diabetes Obes Metab. 2012 Jan;14(1):77-82. doi: 10.1111/j.1463-1326.2011.01493.x. Epub 2011 Oct 30.

Results Reference

result

PubMed Identifier

21883438

Citation

Davies MJ, Chubb BD, Smith IC, Valentine WJ. Cost-utility analysis of liraglutide compared with sulphonylurea or sitagliptin, all as add-on to metformin monotherapy in Type 2 diabetes mellitus. Diabet Med. 2012 Mar;29(3):313-20. doi: 10.1111/j.1464-5491.2011.03429.x.

Results Reference

result

PubMed Identifier

22851600

Citation

Pratley RE, Nauck MA, Bailey T, Montanya E, Filetti S, Garber AJ, Thomsen AB, Furber S, Davies M; 1860-LIRA-DPP-4 Study Group. Efficacy and safety of switching from the DPP-4 inhibitor sitagliptin to the human GLP-1 analog liraglutide after 52 weeks in metformin-treated patients with type 2 diabetes: a randomized, open-label trial. Diabetes Care. 2012 Oct;35(10):1986-93. doi: 10.2337/dc11-2113. Epub 2012 Jul 30.

Results Reference

result

PubMed Identifier

22834986

Citation

Lee WC, Samyshkin Y, Langer J, Palmer JL. Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis. J Med Econ. 2012;15 Suppl 2:28-37. doi: 10.3111/13696998.2012.716111. Epub 2012 Aug 13.

Results Reference

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PubMed Identifier

22862847

Citation

Niswender K, Pi-Sunyer X, Buse J, Jensen KH, Toft AD, Russell-Jones D, Zinman B. Weight change with liraglutide and comparator therapies: an analysis of seven phase 3 trials from the liraglutide diabetes development programme. Diabetes Obes Metab. 2013 Jan;15(1):42-54. doi: 10.1111/j.1463-1326.2012.01673.x. Epub 2012 Sep 9.

Results Reference

result

PubMed Identifier

23010561

Citation

Alves C, Batel-Marques F, Macedo AF. A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer. Diabetes Res Clin Pract. 2012 Nov;98(2):271-84. doi: 10.1016/j.diabres.2012.09.008. Epub 2012 Sep 23.

Results Reference

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PubMed Identifier

23186975

Citation

King AB, Montanya E, Pratley RE, Blonde L, Svendsen CB, Donsmark M, Sesti G. Liraglutide achieves A1C targets more often than sitagliptin or exenatide when added to metformin in patients with type 2 diabetes and a baseline A1C <8.0%. Endocr Pract. 2013 Jan-Feb;19(1):64-72. doi: 10.4158/EP12232.OR.

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PubMed Identifier

25504028

Citation

Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12. Erratum In: Diabetes Care. 2015 Aug;38(8):1622.

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PubMed Identifier

26936426

Citation

Davidson JA, Orsted DD, Campos C. Efficacy and safety of liraglutide, a once-daily human glucagon-like peptide-1 analogue, in Latino/Hispanic patients with type 2 diabetes: post hoc analysis of data from four phase III trials. Diabetes Obes Metab. 2016 Jul;18(7):725-8. doi: 10.1111/dom.12653. Epub 2016 Apr 28.

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PubMed Identifier

23537458

Citation

Langer J, Hunt B, Valentine WJ. Evaluating the short-term cost-effectiveness of liraglutide versus sitagliptin in patients with type 2 diabetes failing metformin monotherapy in the United States. J Manag Care Pharm. 2013 Apr;19(3):237-46. doi: 10.18553/jmcp.2013.19.3.237.

Results Reference

derived

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

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The Effect of Liraglutide Compared to Sitagliptin, Both in Combination With Metformin on Glycaemic Control in Subjects With Type 2 Diabetes Mellitus

Diabetes, Diabetes Mellitus, Type 2

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial