Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
Tracking Information
Start Date ICMJE | October 2007 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: October 26, 2009) |
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Original Primary Outcome Measures ICMJE (submitted: July 27, 2007) | HbA1c level from baseline to 54 weeks (based on clinic visits every 6 weeks). [ Time Frame: 54 weeks ] |
Change History | Complete list of historical versions of study NCT00509262 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: October 26, 2009) |
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Original Secondary Outcome Measures ICMJE (submitted: July 27, 2007) | Lower incidence of hypoglycemic events [ Time Frame: Over 54 weeks ] |
Descriptive Information
Brief Title ICMJE | Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency |
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Official Title ICMJE | 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 |
Brief Summary | The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in patients with moderate and severe renal insufficiency. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 500 | ||||
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Estimated Completion Date | March 2011 | ||||
Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 30 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Chile, Colombia, France, Germany, Hong Kong, India, Israel, Malaysia, Mexico, Philippines, Russian Federation, Sweden, Thailand |
Administrative Information
NCT ID ICMJE | NCT00509262 | ||||
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Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
Study ID Numbers ICMJE | 2007_549, MK0431-063 | ||||
Study Sponsor ICMJE | Merck | ||||
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Investigators ICMJE |
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Information Provided By | Merck |
Source: http://clinicaltrials.gov/