Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Merck |
---|---|
Information provided by: | Merck |
ClinicalTrials.gov Identifier: | NCT00701090 |
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.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus, Non Insulin Dependent Diabetes Mellitus, Non-Insulin-Dependent |
Drug: Comparator: sitagliptin phosphate Drug: Comparator: glimepiride |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 1050 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
sitagliptin
|
Drug: Comparator: sitagliptin phosphate
100 mg sitagliptin per day; Duration of Treatment: 34 weeks
|
2: Active Comparator
glimepiride
|
Drug: Comparator: glimepiride
glimepiride 1 mg per day to be up-titrated as considered appropriate by the investigator, based upon the results of patient's self-blood glucose monitoring (SBGM) over the initial 18 weeks of the double-blind treatment period. The maximum dose of glimepiride must not be higher than 6mg/day.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
Study ID Numbers: | 2008_503, MK0431-803 |
Study First Received: | June 17, 2008 |
Last Updated: | May 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00701090 History of Changes |
Health Authority: | Austria: Federal Ministry for Health and Women |
Type 2 Diabetes Mellitus Non Insulin Dependent |
Metabolic Diseases Immunologic Factors Metformin Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Immunosuppressive Agents Protease Inhibitors Sitagliptin |
Dipeptidyl-Peptidase IV Inhibitors Glimepiride Hypoglycemic Agents Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Cardiovascular Agents Immunosuppressive Agents Pharmacologic Actions |
Protease Inhibitors Sitagliptin Dipeptidyl-Peptidase IV Inhibitors Glimepiride Hypoglycemic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Glucose Metabolism Disorders |