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)
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: October 2009
Intervention(s) in this Clinical Trial
- Drug: sitagliptin
- Sitagliptin 100 mg q.d. (q.d. = once daily); Duration of Treatment: 30 weeks
- Drug: Comparator: glimepiride
- glimepiride 1 mg per day to be up-titrated (up to week 18 of the double-blind treatment period) as considered appropriate by the investigator, based upon the results of patient's self blood glucose monitoring (SBGM). The maximum dose of glimepiride must not be higher than 6 mg/day.
- Drug: open-label metformin
- open-label metformin oral tablets (≥1500 mg/day) in addition to Glimepiride or Sitagliptin treatment.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- sitagliptin
- Active Comparator: 2
- glimepiride
Outcome Measures for this Clinical Trial
Primary Measures
- Change From Baseline in HbA1c at Week 30
- Time Frame: Week 0 to Week 30
Safety Issue?: No
- Time Frame: Week 0 to Week 30
Secondary Measures
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30
- Time Frame: Week 0 to Week 30
Safety Issue?: No
- Time Frame: Week 0 to Week 30
- Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30
- Time Frame: Week 0 to Week 30
Safety Issue?: No
- Time Frame: Week 0 to Week 30
- Change From Baseline in Body Weight at Week 30
- Time Frame: Week 0 to Week 30
Safety Issue?: No
- Time Frame: Week 0 to Week 30
- Percent of Patients With A1C <7.0% at Week 30
- Time Frame: Week 30
Safety Issue?: No
- Time Frame: Week 30
- Percent of Patients With A1C <6.5% at Week 30
- Time Frame: Week 30
Safety Issue?: No
- Time Frame: Week 30
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Merck Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00701090
Study ID Number: MK-0431-803
ClinicalTrials.gov Identifier: NCT00701090
Health Authority: Austria: Federal Ministry for Health and Women
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00701090
