NCT00631488
Completed
Phase 2
A Phase IIa, Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of MK0893 in Combination With Sitagliptin or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ConditionsDiabetes Mellitus, Type 2
Overview
- Phase
- Phase 2
- Intervention
- MK-0893
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 146
- Primary Endpoint
- Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This study will test the effectiveness and safety of treatment with MK-0893 in combination with other drugs commonly used to treat type 2 diabetes for a duration up to 13 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants who have Type 2 Diabetes Mellitus, with suboptimal glucose control, while either not on AHA (antihyperglycemic agent) therapy or on monotherapy or on low-dose combination therapy
Exclusion Criteria
- •Participants have a history of Type 1 Diabetes Mellitus
- •Participants taking insulin or thiazolidinediones (TZDs: peroxisome proliferator-activated receptor \[PPAR\]-gamma agonists)
- •Participants who have a contraindication to metformin or sitagliptin
Arms & Interventions
MK-0893 + Sitagliptin
Intervention: MK-0893
MK-0893 + Sitagliptin
Intervention: Sitagliptin
MK-0893 + Sitagliptin
Intervention: Placebo for Metformin
MK-0893 + Metformin
Intervention: MK-0893
MK-0893 + Metformin
Intervention: Metformin
MK-0893 + Metformin
Intervention: Placebo for Sitagliptin
Sitagliptin + Metformin
Intervention: Sitagliptin
Sitagliptin + Metformin
Intervention: Metformin
Sitagliptin + Metformin
Intervention: Placebo for MK-0893
Outcomes
Primary Outcomes
Change From Baseline (BL) to Week 4 in 24-hour Weighted Mean Glucose (WMG) Levels
Time Frame: BL, 4 weeks (end of double-blind treatment period)
Secondary Outcomes
- Change From BL to Week 4 in the 2-Hour Total GLP-1 Total AUC(BL, 4 weeks (end of double-blind treatment period))
- Change From BL to Week 4 in Fasting Plasma Glucose (FPG)(BL, 4 weeks (end of double-blind treatment period))
- Change From BL to Week 4 in 2-hr Glucose Area Under The Curve (AUC)(BL, 4 weeks (end of double-blind treatment period))
- Change From BL to Week 4 in the 2-Hour Active GLP-1 Total AUC(BL, 4 weeks (end of double-blind treatment period))
Similar Trials
Completed
Phase 3
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-061)Major Depressive DisorderNCT00035295Merck Sharp & Dohme LLC584
Completed
Phase 2
A Study to Test the Safety and Efficacy of MK-8998 in Acutely Psychotic Participants With Schizophrenia (MK-8998-004)SchizophreniaNCT00827918Merck Sharp & Dohme LLC216
Completed
Phase 2
A Study of Safety and Efficacy of MK0859 (Anacetrapib) in Japanese Patients With Dyslipidemia (0859-029)DyslipidemiaNCT00977288Merck Sharp & Dohme LLC408
Completed
Phase 2
A Study to Test MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (MK-0941-017)Type 2 Diabetes MellitusNCT00792935Merck Sharp & Dohme LLC143
Terminated
Phase 2
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)Diabetes Mellitus, Type 2NCT00767000Merck Sharp & Dohme LLC813