| July 27, 2007 |
| October 28, 2009 |
| October 2007 |
| March 2011 (final data collection date for primary outcome measure) |
- HbA1c level change from baseline to 54 weeks compared to glipizide. [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
- Lower incidence of hypoglycemic events compared to glipizide [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
|
| HbA1c level from baseline to 54 weeks (based on clinic visits every 6 weeks). [ Time Frame: 54 weeks ] |
| Complete list of historical versions of study NCT00509262 on ClinicalTrials.gov Archive Site |
- Effects of sitagliptin compared with glipizide on body weight and FPG. [ Time Frame: over 54 weeks ] [ Designated as safety issue: No ]
- Change from baseline of sitagliptin on HbA1c [ Time Frame: over 54 weeks ] [ Designated as safety issue: No ]
|
| Lower incidence of hypoglycemic events [ Time Frame: Over 54 weeks ] |
| |
| Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency |
| A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control |
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in patients with moderate and severe renal insufficiency. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
- Type 2 Diabetes Mellitus
- Renal Insufficiency, Chronic
|
- Drug: Comparator: sitagliptin phosphate
- Drug: Comparator: Comparator: Placebo (unspecified)
- Drug: Comparator: Comparator: glipizide
|
- Placebo Comparator: Arm 1: drug + Pbo comparator
- Placebo Comparator: Arm 2: drug + Pbo comparator
- Active Comparator: Arm 3: Active comparator
|
| |
| |
| Recruiting |
| 500 |
| March 2011 |
| March 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Patient has type 2 diabetes mellitus
- Patient has moderate or severe renal insufficiency
Exclusion Criteria:
- Patient has type 1 diabetes mellitus or a history of ketoacidosis
- Patient is on a new weight loss program
- Patient has active liver disease
- Patient is on dialysis or is likely to need dialysis during the study
|
| Both |
| 30 Years and older |
| No |
| Contact: Toll Free Number |
1-888-577-8839 |
|
|
|
| United States, Chile, Colombia, Costa Rica, France, Germany, Guatemala, Hong Kong, India, Israel, Lebanon, Lithuania, Malaysia, Mexico, Peru, Philippines, Romania, Russian Federation, Sweden, Thailand, Turkey |
| |
| NCT00509262 |
| Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. |
| 2007_549, MK0431-063 |
| Merck |
|
| Study Director: |
Medical Monitor |
Merck |
|
|
| Merck |
| October 2009 |
