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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 30

Percent 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

Page last updated: August 20, 2015

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