Clinical Trial Details
| Trial ID: | L0087 |
| Source ID: | NCT00095056 |
| Associated Drug: | Sitagliptin |
| Title: | An Investigational Drug in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (0431-028)(COMPLETED) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT00095056/results |
| Conditions: | Diabetes Mellitus, Type 2|Chronic Renal Insufficiency |
| Interventions: | DRUG: sitagliptin|DRUG: Placebo to Sitagliptin|DRUG: glipizide|DRUG: Placebo to glipizide |
| Outcome Measures: | Primary: Safety and Tolerability of Sitagliptin After 12 Weeks of Treatment, Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment., Week 0 through Week 12 | Secondary: Safety and Tolerability of Sitagliptin Over 54 Weeks, Safety and tolerability were measured in terms of the number of patients with clinical adverse experiences (CAEs), serious CAEs, drug-related CAEs, laboratory adverse experiences (LAEs), serious LAEs, and drug-related LAEs. Drug-relationship was assessed by the study investigator according to his/her best clinical judgment., Week 0 through Week 54 |
| Sponsor/Collaborators: | Sponsor: Merck Sharp & Dohme LLC |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 91 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2004-10 |
| Completion Date: | 2006-07 |
| Results First Posted: | 2010-07-23 |
| Last Update Posted: | 2015-04-02 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00095056 |
