A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus, Non Insulin Dependent.; Diabetes Mellitus, Non-Insulin-Dependent
Intervention: sitagliptin (Drug); Comparator: glimepiride (Drug); open-label metformin (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
A study to see if better control of type 2 diabetes can occur in patients taking a stable
dose of metformin when they are also provided either sitagliptin or glimepiride. This study
will also see if this treatment is safe and tolerable.
Clinical Details
Official title: A Phase III, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin Compared With the Addition of Glimepiride in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change From Baseline in HbA1c at Week 30
Secondary outcome: Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30 Change From Baseline in Body Weight at Week 30 Percent of Patients With A1C <7.0% at Week 30 Percent of Patients With A1C <6.5% at Week 30
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 years or older
- Diagnosed with type 2 diabetes
- On a stable dose of metformin of at least 1500 mg per day
Exclusion Criteria:
- History of type 1 diabetes
- Pregnant
- HIV positive
- On a weight loss program or medication
- Has a history of blood disorder, certain cancers, heart, liver or kidney disease
Locations and Contacts
Additional Information
MedWatch - FDA maintained medical product safety Information Merck: Patient & Caregiver U.S. Product Web Site
Starting date: May 2008
Last updated: March 23, 2015
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