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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: sitagliptin; Drug: liraglutide; Drug: glimepiride; Drug: metformin

• Registration Number: NCT01296412
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Study Start: 2011-03-11
• Primary Completion: 2012-02-29
• Study Completion: 2012-02-29
• Results First Submitted: 2013-02-05
• Results First Submitted QC: 2013-02-05
• Results First Posted: 2013-03-15
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 653

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin +/- glimepiride	sitagliptin	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.
Sitagliptin +/- glimepiride	glimepiride	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.
Sitagliptin +/- glimepiride	metformin	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	liraglutide	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.
Liraglutide	metformin	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (A1C)	Baseline and Week 26	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

Name	Time	Method
Change From Baseline in Fasting Plasma Glucose (FPG)	Baseline and Week 26	Change from baseline at Week 26 is defined as Week 26 minus Week 0.
Percentage of Participants Reaching A1C Goal of <7.0%	Week 26
Percentage of Participants Reaching A1C Goal of <6.5%	Week 26