Clinical Trial Details
| Trial ID: | L5658 |
| Source ID: | NCT01357252 |
| Associated Drug: | Vildagliptin |
| Title: | Vildagliptin add-on to Glimepiride Versus Placebo Added to Glimepiride in Type 2 Diabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: vildagliptin|DRUG: Placebo |
| Outcome Measures: | Primary: Change from baseline in HbA1c, 24 weeks | Secondary: Change from baseline in Fasting Plasma Glucose, 24 weeks|Safety and tolerability (Frequency of adverse events, serious adverse events, and notable laboratory abnormalities) of add-on therapy with vildagliptin 50 mg qd to glimepiride as compared to pbo, 24 weeks|Responder rates - proportion of subjects reaching predefined HbA1c targets, 24 weeks |
| Sponsor/Collaborators: | Sponsor: Novartis Pharmaceuticals |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 279 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2011-04 |
| Completion Date: | 2013-01 |
| Results First Posted: | |
| Last Update Posted: | 2014-04-03 |
| Locations: | Novartis Investigative Site, Beijing, Beijing, 100088, China|Novartis Investigative Site, Shijiazhuang, Hebei, 050051, China|Novartis Investigative Site, Wuhan, Hubei, 430070, China|Novartis Investigative Site, Changsha, Hunan, 410003, China|Novartis Investigative Site, Nanjing, Jiangsu, 210006, China|Novartis Investigative Site, Nanjing, Jiangsu, 210008, China|Novartis Investigative Site, Nanjing, Jiangsu, 210029, China|Novartis Investigative Site, Zhenjiang, Jiangsu, 212001, China|Novartis Investigative Site, ShenYang, Liaoning, 110003, China|Novartis Investigative Site, Shanghai, Shanghai, China|Novartis Investigative Site, Tianjin, Tianjin, 300211, China|Novartis Investigative Site, Beijing, 100029, China|Novartis Investigative Site, Beijing, 100034, China|Novartis Investigative Site, Beijing, 100730, China|Novartis Investigative Site, Beijing, China|Novartis Investigative Site, Guang zhou, 510080, China|Novartis Investigative Site, Shanghai, 200040, China|Novartis Investigative Site, Shanghai, 200233, China |
| URL: | https://clinicaltrials.gov/show/NCT01357252 |
