A Study of Different Doses of Sitagliptin (MK-0431) in Participants With Type 2 Diabetes Mellitus (MK-0431-014)
Phase 2
Completed
- Conditions
- Type II Diabetes Mellitus
- Interventions
- Registration Number
- NCT00481663
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
A study of different doses of MK-0431 in participants with type 2 diabetes mellitus. There have been 3 extensions to the base study (Extension 1: up to Week 52, Extension 2: up to Week 106, and Extension 3: up to Week 158). The primary hypothesis for the study is that In participants with type 2 diabetes who have inadequate glycemic control, after 12 weeks of treatment, a dose-response will be seen across once-daily doses of MK-0431 in lowering hemoglobin A1C (HbA1c).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 555
Inclusion Criteria
- Men and non-pregnant women
- Fasting plasma glucose >= 130 mg/dL
- HbA1c >=6.5% and >10.0%
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Exclusion Criteria
- You have a history of type I diabetes
- You are on a weight loss program with ongoing weight loss or taking weight loss medication
- You have had surgery within 30 days
- You hvae hepatitis B or C.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sitagliptin 25 mg once daily Rescue Sitaglipin (MK-0431), 25 mg, once daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods. Sitagliptin 50 mg once daily Rescue Sitagliptin, 50 mg, once daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods. Sitaglipin 100 mg once daily Rescue Sitagliptin, 100 mg, once daily for 158 weeks, orally Sitagliptin 50 mg twice daily Rescue Sitagliptin 50 mg, twice daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods. Placebo to Sitagliptin → Metformin Placebo to sitagliptin Placebo to Sitagliptin, once daily, orally for 12 weeks. Participants randomized to the placebo treatment group during the base study were reallocated to treatment with metformin 850 mg twice daily (b.i.d., initiated with 850 mg q.d. for 4 weeks then force titrated to 850 mg b.i.d.) during either the first or initiation of the second extensions study periods. Placebo to Sitagliptin → Metformin Rescue Placebo to Sitagliptin, once daily, orally for 12 weeks. Participants randomized to the placebo treatment group during the base study were reallocated to treatment with metformin 850 mg twice daily (b.i.d., initiated with 850 mg q.d. for 4 weeks then force titrated to 850 mg b.i.d.) during either the first or initiation of the second extensions study periods. Sitagliptin 25 mg once daily Sitagliptin Sitaglipin (MK-0431), 25 mg, once daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods. Sitagliptin 50 mg once daily Sitagliptin Sitagliptin, 50 mg, once daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods. Sitagliptin 50 mg twice daily Sitagliptin Sitagliptin 50 mg, twice daily for 12 weeks, orally. Due to interim analysis of this study and another Phase IIB study, participants in this arm were switched into the 100-mg once daily arm during either the first or initiation of the second extensions study periods. Sitaglipin 100 mg once daily Sitagliptin Sitagliptin, 100 mg, once daily for 158 weeks, orally Placebo to Sitagliptin → Metformin Metformin Placebo to Sitagliptin, once daily, orally for 12 weeks. Participants randomized to the placebo treatment group during the base study were reallocated to treatment with metformin 850 mg twice daily (b.i.d., initiated with 850 mg q.d. for 4 weeks then force titrated to 850 mg b.i.d.) during either the first or initiation of the second extensions study periods.
- Primary Outcome Measures
Name Time Method Number of Participants Who Experienced One or More Adverse Events (AE) up to Week 14 Up to Week 14 Number of Participants Who Experienced One or More AE up to Week 160 Up to Week 160 Change from Baseline in HbA1C at Week 12 Baseline and Week 12 Number of participants Who Discontinued Study Treatment Due to An AE up to Week 12 Up to Week 12 Number of participants Who Discontinued Study Treatment Due to An AE up to Week 106 Up to Week 106 Number of participants Who Discontinued Study Treatment Due to An AE up to Week 158 Up to Week 158 Number of Participants Who Experienced One or More AE up to Week 54 Up to Week 54 Number of Participants Who Experienced One or More AE up to Week 108 Up to Week 108 Number of participants Who Discontinued Study Treatment Due to An AE up to Week 52 Up to Week 52
- Secondary Outcome Measures
Name Time Method Change from Baseline in HbA1C at Week 106 Baseline and Week 106 Change from Baseline in FPG at Week 158 Baseline and Week 158 Change from Baseline in Body Weight at Week 106 Baseline and Week 106 Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 12 Baseline and Week 12 Change From Baseline in Daily Seven-Point Fingerstick Glucose Average at Week 52 Baseline and Week 52 Change from Baseline in FPG at Week 52 Baseline and Week 52 Change from Baseline in Body Weight at Week 52 Baseline and Week 52 Change from Baseline in Body Weight at Week 158 Baseline and Week 158 Change From Baseline in Serum Fructosamine at Week 12 Baseline and Week 12 Change from Baseline in HbA1C at Week 52 Baseline and Week 52 Change from Baseline in HbA1C at Week 158 Baseline and Week 158 Change from Baseline in Fasting Plasma Glucose (FPG) at Week 12 Baseline and Week 12 Change from Baseline in FPG at Week 106 Baseline and Week 106 Change from Baseline in Body Weight at Week 12 Baseline and Week 12