A Study to Evaluate the Efficacy and Safety of Sitagliptin and MK0431A in Comparison to a Commonly Used Medication in Patients With Type 2 Diabetes (0431-068)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Comparator: sitagliptin phosphate (sitagliptin) (Drug); sitagliptin phosphate (+) metformin hydrochloride (Drug); Comparator: pioglitazone (Drug); Matching placebo to pioglitazone (Drug); Matching placebo to sitagliptin (Drug); Matching Placebo to Sita/Met FDC (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
The purpose of this study is to evaluate the efficacy and safety of sitagliptin and MK0431A
in comparison to a commonly used medication in patients with type 2 diabetes.
Clinical Details
Official title: A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of Sitagliptin and MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in Hemoglobin A1c (A1C) in the Sita/Met Fixed-Dose Combination (FDC) or Pioglitazone Groups at 40 WeeksChange in Hemoglobin A1c (A1C) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
Secondary outcome: Change in 2-hour Postprandial Glucose (PMG) in the Sita/Met FDC or Pioglitazone Groups at 40 WeeksChange in 2-hour Postprandial Glucose (PMG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks Change in Fasting Plasma Glucose (FPG) in the Sita/Met FDC or Pioglitazone Groups at 40 Weeks Change in Fasting Plasma Glucose (FPG) in Participants Treated With Sitagliptin or Pioglitazone at 12 Weeks
Eligibility
Minimum age: 18 Years.
Maximum age: 78 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients between the ages of 18 and 78 with type 2 diabetes mellitus
- Patient has not been on any antihyperglycemic agent (Insulin or oral) in the last 3
months
Exclusion Criteria:
- Patient has a history of type 1 diabetes mellitus or a history of ketoacidosis
- Patient has previously been treated with sitagliptin or has previously been in a
study using a DPP-4 inhibitor
Locations and Contacts
Additional Information
MedWatch - FDA maintained medical product safety Information Merck: Patient & Caregiver U.S. Product Web Site
Starting date: January 2008
Last updated: May 4, 2015
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