Clinical Trial Details
| Trial ID: | L1838 |
| Source ID: | NCT00501020 |
| Associated Drug: | Rosiglitazone |
| Title: | Comparison of the Efficacy and Tolerability of the Addition of AVANDIA to Submaximal Doses of Metformin |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Rosiglitazone |
| Outcome Measures: | Primary: The primary efficacy variable was HbA1c change from baseline (visit 3) after 24 weeks of treatment with either RSG+MET combination therapy or Metformin monotherapy., 24 Weeks | Secondary: Secondary efficacy variables included: the change from baseline (visit 3) at week 24 (visit) in FPG, immunoreactive insulin, HbA1c and FPG responders, Questionnaire-Tolerability of GI side-effects, and Questionnaire - Quality of Life., 24 Weeks |
| Sponsor/Collaborators: | Sponsor: GlaxoSmithKline |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 750 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT |
| Start Date: | 2001-06-05 |
| Completion Date: | 2003-02-13 |
| Results First Posted: | |
| Last Update Posted: | 2017-10-09 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT00501020 |
