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
Overview
- Phase
- Phase 3
- Intervention
- sitagliptin
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 653
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (A1C)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sitagliptin +/- 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.
Intervention: sitagliptin
Sitagliptin +/- 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.
Intervention: glimepiride
Sitagliptin +/- 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.
Intervention: metformin
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.
Intervention: 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.
Intervention: metformin
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1c (A1C)
Time Frame: 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 Outcomes
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline and Week 26)
- Percentage of Participants Reaching A1C Goal of <7.0%(Week 26)
- Percentage of Participants Reaching A1C Goal of <6.5%(Week 26)