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Clinical Trials/NCT00103857
NCT00103857
Completed
Phase 3

A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Merck Sharp & Dohme LLC0 sites1,208 target enrollmentMarch 17, 2005
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ConditionsType 2 Diabetes Mellitus
DrugsComparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)Comparator: MK0431 100 mg q.d. (q.d. = once daily)Comparator: Placebo (Phase A)/Metformin (Phase B)Comparator: Metformin 500 mg b.i.d.Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.Comparator: Metformin 1000 mg b.i.d.

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Merck Sharp & Dohme LLC
Enrollment
1208
Primary Endpoint
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
Status
Completed
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).

Registry
clinicaltrials.gov
Start Date
March 17, 2005
End Date
February 21, 2008
Last Updated
8 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •54-Week Base Study:
  • •Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)
  • •50-Week Extension Study:
  • •Patients who complete the 54-week base study are eligible to enter the 50-week extension study

Exclusion Criteria

  • •Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)

Outcomes

Primary Outcomes

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24

Time Frame: Week 24

HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

Secondary Outcomes

  • Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54(Week 54)
  • Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24(Week 24)
  • Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54(Week 54)
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54(Week 54)
  • Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104(Week 104)
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104(Week 104)
  • Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104(Week 104)
  • Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24(Week 24)

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