Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
Phase 3
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT00087516
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 741
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitagliptin 200 mg/200 mg Metformin - Rescue Phase A and B: Oral tablets of sitagliptin 200 mg q.d Placebo/Sitagliptin 100 mg Metformin - Rescue Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d. Placebo/Sitagliptin 200 mg Placebo Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d. Sitagliptin 100 mg/100 mg Metformin - Rescue Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d ) Placebo/Sitagliptin 100 mg Placebo Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d. Sitagliptin 100 mg/100 mg Sitagliptin (MK0431) Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d ) Placebo/Sitagliptin 200 mg Metformin - Rescue Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d. Sitagliptin 200 mg/200 mg Sitagliptin Phase A and B: Oral tablets of sitagliptin 200 mg q.d
- Primary Outcome Measures
Name Time Method Change From Baseline in A1C at Week 24 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 Outcome Measures
Name Time Method Change From Baseline in FPG at Week 24 Weeks 0-24 Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.
Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24 Weeks 0-24 Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.
Change From Baseline in A1C at Week 104 Weeks 0-104 A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.
Change From Baseline in FPG at Week 104 Weeks 0-104 Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.
Change From Baseline in 2-hr PMG at Week 104 Weeks 0-104 Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.