Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease
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: November 18, 2009) | HbA1c level from baseline to 54 weeks [ Time Frame: 54 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: July 27, 2007) | HbA1c level from baseline to 54 weeks (based on measurements at clinic visits every 6 weeks) [ Time Frame: 54 weeks ] |
Change History | Complete list of historical versions of study NCT00509236 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: November 18, 2009) | Effect of sitagliptin compared with glipizide on hypoglycemic events, HbA1c, FPG [ Time Frame: At the end of 54 weeks ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE (submitted: July 27, 2007) | A review of clinical adverse experiences, laboratory values, weight, vital signs and ECG data [ Time Frame: At the end of 54 weeks ] |
Descriptive Information
Brief Title ICMJE | Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease |
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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 End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control |
Brief Summary | The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in patients withT2DM and end-stage renal disease on dialysis |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, 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 | 150 | ||||
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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, Germany, Hong Kong, Israel, Russian Federation |
Administrative Information
NCT ID ICMJE | NCT00509236 | ||||
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Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
Study ID Numbers ICMJE | 2007_550, MK0431-073 | ||||
Study Sponsor ICMJE | Merck | ||||
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Investigators ICMJE |
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Information Provided By | Merck |
Source: http://clinicaltrials.gov/