A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Overview
- Phase
- Phase 3
- Intervention
- Sitagliptin (MK0431)
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 741
- Primary Endpoint
- Change From Baseline in A1C at Week 24
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with type 2 diabetes mellitus
- •Patient is not pregnant or breastfeeding
- •Male or female patient unlikely to conceive
- •Patient not on an antihyperglycemic drug
Exclusion Criteria
- •Patient has history of type 1 diabetes mellitus
- •Patient has history of ketoacidosis
- •Patient requires insulin within 8 weeks prior to start of study
- •Patient on weight loss program and is not in maintenance phase
- •Patient taking weight loss medication within 8 weeks prior to start of study
- •Patient on or likely to require = 14 days or repeated courses of corticosteroids
- •Patient taking immunosuppressive/immunomodulating medication
- •Patient taking digoxin or other cardiac medication
- •Patient has undergone surgical general anesthesia within 30 days prior to start of study
- •Patient taking investigational drug within 8 weeks prior to start of study
Arms & Interventions
Sitagliptin 100 mg/100 mg
Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )
Intervention: Sitagliptin (MK0431)
Sitagliptin 100 mg/100 mg
Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )
Intervention: Metformin - Rescue
Sitagliptin 200 mg/200 mg
Phase A and B: Oral tablets of sitagliptin 200 mg q.d
Intervention: Sitagliptin
Sitagliptin 200 mg/200 mg
Phase A and B: Oral tablets of sitagliptin 200 mg q.d
Intervention: Metformin - Rescue
Placebo/Sitagliptin 100 mg
Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.
Intervention: Placebo
Placebo/Sitagliptin 100 mg
Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.
Intervention: Metformin - Rescue
Placebo/Sitagliptin 200 mg
Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.
Intervention: Placebo
Placebo/Sitagliptin 200 mg
Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.
Intervention: Metformin - Rescue
Outcomes
Primary Outcomes
Change From Baseline in A1C at Week 24
Time Frame: Weeks 0-24
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Secondary Outcomes
- Change From Baseline in FPG at Week 24(Weeks 0-24)
- Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24(Weeks 0-24)
- Change From Baseline in A1C at Week 104(Weeks 0-104)
- Change From Baseline in FPG at Week 104(Weeks 0-104)
- Change From Baseline in 2-hr PMG at Week 104(Weeks 0-104)