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A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

semaglutide

placebo

liraglutide

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

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

Inclusion Criteria:

Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months
Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months
HbA1c: 7.0-10.0 % (both inclusive)
Body weight between 60 kg and 110 kg

Exclusion Criteria:

Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months
Impaired liver or kidney function
Proliferative retinopathy or maculopathy requiring acute treatment
Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension
Recurrent major hypoglycaemia or hypoglycaemic unawareness
Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

HbA1c

Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.

Secondary Outcome Measures

Percentage of Subjects With an Adverse Events

The results of adverse event presented here are treatment emergent, i.e., TEAE. A TEAE was defined as an event that had onset on or after the first date (week 0) on trial product and no later than 5 weeks after the last date on trial product (week 17), or that had onset before the first date on trial product and increases in severity during the treatment period until 5 weeks after the last date on trial product.

Percentage of Subjects With Hypoglycaemic Episode

The results of hypoglycaemic episode presented here are treatment emergent. Hypoglycaemic episodes were defined as treatment emergent if they had onset on or after the first day of randomised treatment (in week 0) and no later than 5 weeks after the last date on trial product (week 17). Hypoglycaemic episodes are classified as follows: Major: If the subject was not able to treat himself or herself and was needed to be administered food, glucagon or intravenous (i.v.) glucose by another person. Minor: If the subject was able to treat himself or herself and measured plasma glucose was <3.1 mmol/L (56 mg/dL). Symptoms only: If the subject was able to treat himself or herself and measured plasma glucose was >=3.1 mmol/L (56 mg/dL) or no plasma glucose measurement was done.

Change From Baseline in ECG

A standard 12 lead electrocardiogram (ECG) with a 10-second rhythm strip was performed at screening (week -2) and at the end of treatment (week 12). The time frame should be read as "week -2, week 12". Change from baseline in ECG was measured in terms of number of subjects in each category (normal, abnormal, not clinically significant [NCS] or abnormal clinically significant [CS]) at week -2 and week 12 (i.e., change in each category in terms of number of subjects from week -2 to week 12).

Change From Baseline in Vital Signs (Pulse)

Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Vital Signs (Blood Pressure; SBP)

Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Vital Signs (Blood Pressure; DBP)

Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)

Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)

Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)

Change from baseline in haematocrit (the proportion of blood that consists of red blood cells) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)

Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)

Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)

Change from baseline in monocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)

Change from baseline in neutrophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)

Change from baseline in thrombocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)

Change from baseline in erythrocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)

Change from baseline in leukocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)

Change from baseline in albumin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)

Change from baseline in alkaline phosphatase was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)

Change from baseline in aspartate aminotransferase (AST) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)

Change from baseline in alanine aminotransferase (ALAT) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)

Change from baseline in total bilirubin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)

Change from baseline in calcium, total was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)

Change from baseline in calcium, ionised was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)

Change from baseline in creatinine was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)

Change from baseline in potassium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)

Change from baseline in sodium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)

Change from baseline in urea was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)

Change from baseline in urine-glucose was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L, or missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)

Change from baseline in urine-haemoglobin was measured in terms of number of subjects in each category (negative, trace, small, moderate/large and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)

Change from baseline in urine-ketone was measured in terms of number of subjects in each category (negative, positive, >=55 mmol/L and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)

Change from baseline in urine-pH was measured in terms of number of subjects in each category (pH=6.0, 6.5, 7.0, 7.5, 8.0, >=8.5 and missing) at week 0 and week 12 (i.e., change in each category in terms of number of subjects from week 0 to week 12).

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)

Change from baseline in urine-protein was measured in terms of number of subjects in each category at week 0 (negative, 0.3 g/L, 1.0 g/L and missing) and week 12 (negative, trace, 0.3 g/L, 1.0 g/L, >=3.0 g/L and missing). i.e., change in each category in terms of number of subjects from week 0 to week 12.

Change From Baseline in Calcitonin

Change from baseline in calcitonin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Percentage of Subjects Developing Anti-semaglutide Antibodies

Antibodies were measured after 12-week of treatment at week 17; percentage of participants with positive anti-semaglutide antibodies are presented here. Assessments of antibodies were not done for subjects allocated to the open-label liraglutide treatment arms.

Full Information

NCT ID

NCT00696657

First Posted

June 11, 2008

Last Updated

August 1, 2019

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT00696657

Brief Title

A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

Official Title

Investigation of Safety and Efficacy of Five Doses of Semaglutide Versus Placebo and Open-label Liraglutide, as Add on Therapy, in Subjects Diagnosed With Type 2 Diabetes Currently Treated With Metformin or Controlled With Diet and Exercise A 12 Week Multi-centre, Multi National, Double-blind, Placebo-controlled, Randomised, Nine Armed Parallel Group, Dose Finding Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

June 3, 2008 (Actual)

Primary Completion Date

February 5, 2009 (Actual)

Study Completion Date

February 5, 2009 (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 was conducted in Europe,Asia and Africa. Study participants were randomised evenly to treatment with semaglutide (0.1 mg QW - 1.6 mg QW, 6 treatment arms, placebo or liraglutide (1.2 mg QD, or 1.8 mg QD).Treatment allocation to semaglutide or placebo was double-blind, whereas liraglutide treatment was administered open-label.Primary efficacy parameter was HbA1c and the treatment duration was 12 weeks.

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 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

415 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

semaglutide

Other Intervention Name(s)

NN9535

Intervention Description

0.1 mg, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

semaglutide

Other Intervention Name(s)

NN9535

Intervention Description

0.2 mg, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

semaglutide

Other Intervention Name(s)

NN9535

Intervention Description

0.4 mg, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

semaglutide

Other Intervention Name(s)

NN9535

Intervention Description

0.8 mg, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

semaglutide

Other Intervention Name(s)

NN9535

Intervention Description

0.8 mg with titration, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

semaglutide

Other Intervention Name(s)

NN9535

Intervention Description

1.6 mg with titration, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

0.1 mg, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

0.2 mg, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

0.4 mg, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

0.8 mg with titration, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

1.6 mg, once weekly, s.c. injection

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

1.2 mg with titration, once daily, s.c. injection

Intervention Type

Drug

Intervention Name(s)

liraglutide

Intervention Description

1.8 mg with titration, once daily, s.c. injection

Primary Outcome Measure Information:

Title

HbA1c

Description

Change from baseline in HbA1c was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the last observation carried forward (LOCF) approach.

Time Frame

After 12 weeks of treatment.

Secondary Outcome Measure Information:

Title

Percentage of Subjects With an Adverse Events

Description

Time Frame

After 12 weeks of treatment.

Title

Percentage of Subjects With Hypoglycaemic Episode

Description

Time Frame

After 12 weeks of treatment

Title

Change From Baseline in ECG

Description

Time Frame

Week 0, week 12.

Title

Change From Baseline in Vital Signs (Pulse)

Description

Change from baseline in pulse was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Vital Signs (Blood Pressure; SBP)

Description

Change from baseline in systolic blood pressure (SBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Vital Signs (Blood Pressure; DBP)

Description

Change from baseline in diastolic blood pressure (DBP) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Basophils)

Description

Change from baseline in basophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Eosinophils)

Description

Change from baseline in eosinophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haematocrit)

Description

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Haemoglobin)

Description

Change from baseline in haemoglobin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Lymphocytes)

Description

Change from baseline in lymphocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Monocytes)

Description

Change from baseline in monocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Neutrophils)

Description

Change from baseline in neutrophils was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Thrombocytes)

Description

Change from baseline in thrombocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Erythrocytes)

Description

Change from baseline in erythrocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Haematology; Leukocytes)

Description

Change from baseline in leukocytes was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Albumin)

Description

Change from baseline in albumin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Alkaline Phosphatase)

Description

Change from baseline in alkaline phosphatase was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; AST)

Description

Change from baseline in aspartate aminotransferase (AST) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; ALAT)

Description

Change from baseline in alanine aminotransferase (ALAT) was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Total Bilirubin)

Description

Change from baseline in total bilirubin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Total)

Description

Change from baseline in calcium, total was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Calcium, Ionised)

Description

Change from baseline in calcium, ionised was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Creatinine)

Description

Change from baseline in creatinine was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Potassium)

Description

Change from baseline in potassium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Sodium)

Description

Change from baseline in sodium was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Biochemistry; Urea)

Description

Change from baseline in urea was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Glucose)

Description

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Haemoglobin)

Description

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Ketones)

Description

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; pH)

Description

Time Frame

Week 0, week 12

Title

Change From Baseline in Standard Safety Laboratory Parameter (Urinalysis; Protein)

Description

Time Frame

Week 0, week 12

Title

Change From Baseline in Calcitonin

Description

Change from baseline in calcitonin was evaluated after 12 weeks of treatment. Post baseline (week 0) missing values were replaced using the LOCF approach.

Time Frame

Week 0, week 12.

Title

Percentage of Subjects Developing Anti-semaglutide Antibodies

Description

Time Frame

After 12 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women-not-of-childbearing potential diagnosed with type 2 diabetes for at least three months Stable treatment regimen with either metformin (at least 1500 mg) or diet and exercise alone for at least three months HbA1c: 7.0-10.0 % (both inclusive) Body weight between 60 kg and 110 kg Exclusion Criteria: Treatment with insulin, GLP-1 receptor agonists (including liraglutide), dipeptidyl peptidase-4 inhibitors, sulphonylurea, thiazolidinediones, Alpha-GIs, or any investigational drug, within the last three months Impaired liver or kidney function Proliferative retinopathy or maculopathy requiring acute treatment Clinically significant active cardiovascular disease and uncontrolled treated/untreated hypertension Recurrent major hypoglycaemia or hypoglycaemic unawareness Present or planned use of any drug which could interfere with the glucose levels (e.g. systemic corticosteroids)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry B. (GCR, 1452), MD, PhD

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Gratwein

ZIP/Postal Code

8112

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Mödling

ZIP/Postal Code

2340

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1010

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Novo Nordisk Investigational Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Russe

ZIP/Postal Code

7000

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Novo Nordisk Investigational Site

City

Helsinki

ZIP/Postal Code

00270

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Imatra

ZIP/Postal Code

FI-55120

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Mikkeli

ZIP/Postal Code

FI-50100

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Oulu

ZIP/Postal Code

90029

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Tampere

ZIP/Postal Code

33101

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Novo Nordisk Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Former Serbia and Montenegro

Facility Name

Novo Nordisk Investigational Site

City

Dommartin Les Toul

ZIP/Postal Code

54201

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

MONTPELLIER cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novo Nordisk Investigational Site

City

Narbonne

ZIP/Postal Code

11108

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

Falkensee

ZIP/Postal Code

14612

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Hamburg

ZIP/Postal Code

22607

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Ludwigshafen

ZIP/Postal Code

67059

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Marburg

ZIP/Postal Code

35037

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Pohlheim

ZIP/Postal Code

35415

Country

Germany

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1041

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Debrecen

ZIP/Postal Code

4043

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Gyula

ZIP/Postal Code

5700

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Pecs

ZIP/Postal Code

7631

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Szekszárd

ZIP/Postal Code

7100

Country

Hungary

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500082

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chennai

State/Province

Tamil Nadu

ZIP/Postal Code

600086

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Chennai

ZIP/Postal Code

600008

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Hyderabad

ZIP/Postal Code

600034

Country

India

Facility Name

Novo Nordisk Investigational Site

City

Catanzaro

ZIP/Postal Code

88100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Chieti

ZIP/Postal Code

66100

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Firenze

ZIP/Postal Code

50141

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Milano (MI)

ZIP/Postal Code

20132

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Perugia

ZIP/Postal Code

06126

Country

Italy

Facility Name

Novo Nordisk Investigational Site

City

Pretoria

State/Province

Gauteng

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Durban

State/Province

KwaZulu-Natal

ZIP/Postal Code

4091

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Cape Town

State/Province

Western Cape

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Novo Nordisk Investigational Site

City

Almería

ZIP/Postal Code

04001

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Gijón

ZIP/Postal Code

33206

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Novo Nordisk Investigational Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Genève 14

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Novo Nordisk Investigational Site

City

Antalya

ZIP/Postal Code

07058

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34400

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34722

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Istanbul

ZIP/Postal Code

34890

Country

Turkey

Facility Name

Novo Nordisk Investigational Site

City

Addlestone

ZIP/Postal Code

KT15 2BH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bath

ZIP/Postal Code

BA2 1NH

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bexhill-on-Sea

ZIP/Postal Code

TN39 4SP

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Guildford

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Hull

ZIP/Postal Code

HU3 2RW

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Inverness

ZIP/Postal Code

IV2 3UJ

Country

United Kingdom

Facility Name

Novo Nordisk Investigational Site

City

Llanelli

ZIP/Postal Code

SA14 8QF

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

Trowbridge

ZIP/Postal Code

BA14 8QA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

26358288

Citation

Nauck MA, Petrie JR, Sesti G, Mannucci E, Courreges JP, Lindegaard ML, Jensen CB, Atkin SL; Study 1821 Investigators. A Phase 2, Randomized, Dose-Finding Study of the Novel Once-Weekly Human GLP-1 Analog, Semaglutide, Compared With Placebo and Open-Label Liraglutide in Patients With Type 2 Diabetes. Diabetes Care. 2016 Feb;39(2):231-41. doi: 10.2337/dc15-0165. Epub 2015 Sep 10.

Results Reference

derived

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

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A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide

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

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

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