| Trial ID: | L1284 |
| Source ID: | NCT00509262
|
| Associated Drug: |
Sitagliptin
|
| Title: |
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00509262/results
|
| Conditions: |
Diabetes Mellitus, Type 2|Renal Insufficiency, Chronic
|
| Interventions: |
DRUG: Sitagliptin|DRUG: Glipizide|DRUG: Placebo for Sitagliptin|DRUG: Placebo for Glipizide
|
| Outcome Measures: |
Primary: Change From Baseline in Hemoglobin A1c (A1C) Levels at Week 54, A1C represents percentage of glycosylated hemoglobin., Baseline to Week 54|Percentage of Participants With Hypoglycemic Events, Percentage of participants with at least one symptomatic hypoglycemic adverse event, excluding data after initiation of glycemic rescue therapy., Baseline up to 28 days following the last dose of study therapy | Secondary: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 54, Baseline to Week 54|Change From Baseline in Body Weight at Week 54, Baseline to Week 54
|
| Sponsor/Collaborators: |
Sponsor: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
426
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2007-10-09
|
| Completion Date: |
2011-03-16
|
| Results First Posted: |
2012-03-28
|
| Last Update Posted: |
2017-05-12
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT00509262
|
