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Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

sitagliptin

liraglutide

glimepiride

metformin

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

Type 2 diabetes mellitus.
On stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin A1C ≥7.0% and ≤11.0%.
Capable of using a liraglutide pen device.

Exclusion criteria

History of Type 1 Diabetes mellitus.
Use of any oral antihyperglycemic agent (AHA) besides metformin, within the prior 12 weeks of screening.
Cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder.
Impaired liver function.
Impaired kidney function.
History of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study.
History of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment.
Pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study.
Participation in another study with an investigational drug or device within 12 weeks prior to screening.
History of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site.
Participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks.
Surgery within the prior 4 weeks or major surgery planned during the study.
Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
User of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sitagliptin +/- glimepiride

Liraglutide

Arm Description

Sitagliptin 100 mg tablet orally once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride orally for glycemic control.

Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (A1C)

A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline at Week 26 is defined as Week 26 minus Week 0.

Percentage of Participants Reaching A1C Goal of <7.0%

Percentage of Participants Reaching A1C Goal of <6.5%

Full Information

NCT ID

NCT01296412

First Posted

February 14, 2011

Last Updated

May 9, 2017

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT01296412

Brief Title

Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

Official Title

A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

March 11, 2011 (Actual)

Primary Completion Date

February 29, 2012 (Actual)

Study Completion Date

February 29, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment.

6. Conditions and Keywords

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

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

653 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitagliptin +/- glimepiride

Arm Type

Experimental

Arm Description

Arm Title

Liraglutide

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

sitagliptin

Other Intervention Name(s)

MK-0431, Januvia®, Tesavel®, Xelevia®, Ristaben®

Intervention Description

100 mg tablet, orally, once daily.

Intervention Type

Drug

Intervention Name(s)

liraglutide

Other Intervention Name(s)

Victoza®

Intervention Description

0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals.

Intervention Type

Drug

Intervention Name(s)

glimepiride

Other Intervention Name(s)

Amaryl®

Intervention Description

starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.

Intervention Type

Drug

Intervention Name(s)

metformin

Other Intervention Name(s)

Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

Intervention Description

metformin tablets at a dose of ≥1500 mg per day

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin A1c (A1C)

Description

A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.

Time Frame

Baseline and Week 26

Secondary Outcome Measure Information:

Title

Change From Baseline in Fasting Plasma Glucose (FPG)

Description

Change from baseline at Week 26 is defined as Week 26 minus Week 0.

Time Frame

Baseline and Week 26

Title

Percentage of Participants Reaching A1C Goal of <7.0%

Time Frame

Week 26

Title

Percentage of Participants Reaching A1C Goal of <6.5%

Time Frame

Week 26

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Type 2 diabetes mellitus. On stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin A1C ≥7.0% and ≤11.0%. Capable of using a liraglutide pen device. Exclusion criteria History of Type 1 Diabetes mellitus. Use of any oral antihyperglycemic agent (AHA) besides metformin, within the prior 12 weeks of screening. Cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder. Impaired liver function. Impaired kidney function. History of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study. History of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment. Pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study. Participation in another study with an investigational drug or device within 12 weeks prior to screening. History of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site. Participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks. Surgery within the prior 4 weeks or major surgery planned during the study. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2). User of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

23604551

Citation

Charbonnel B, Steinberg H, Eymard E, Xu L, Thakkar P, Prabhu V, Davies MJ, Engel SS. Efficacy and safety over 26 weeks of an oral treatment strategy including sitagliptin compared with an injectable treatment strategy with liraglutide in patients with type 2 diabetes mellitus inadequately controlled on metformin: a randomised clinical trial. Diabetologia. 2013 Jul;56(7):1503-11. doi: 10.1007/s00125-013-2905-1. Epub 2013 Apr 19.

Results Reference

derived

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Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

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