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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 741
- Primary Endpoint
- Change From Baseline in A1C at Week 24
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patient is diagnosed with liver disease
- •Patient has chronic myopathy, progressive neurological/neuromuscular disorder
- •Patient has with severe cardiac conditions within the last 6 months
- •Patient is Human immunodeficiency virus (HIV) positive
- •Patient has hematological disorder
- •Patient has history of malignancy
- •Patient has history of alcohol or drug abuse within the past 3 years
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) (Drug)
Sitagliptin 100 mg/100 mg
Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )
Intervention: Metformin - Rescue (Drug)
Sitagliptin 200 mg/200 mg
Phase A and B: Oral tablets of sitagliptin 200 mg q.d
Intervention: Sitagliptin (Drug)
Sitagliptin 200 mg/200 mg
Phase A and B: Oral tablets of sitagliptin 200 mg q.d
Intervention: Metformin - Rescue (Drug)
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 (Drug)
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 (Drug)
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 (Drug)
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 (Drug)
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)