Clinical Trial Details
| Trial ID: | L6631 |
| Source ID: | NCT00822211 |
| Associated Drug: | Vildagliptin 50 Mg Bid |
| Title: | Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Vildagliptin 50 mg bid|DRUG: Vildagliptin 50 mg qd|DRUG: Placebo |
| Outcome Measures: | Primary: Change from baseline in HbA1c after 24 weeks, 24 weeks | Secondary: Percent of patients with HbA1c < 7% after 24 weeks, 24 weeks|Adverse event profile after 24 weeks of treatment, 24 weeks|Change from baseline in fasting plasma glucose at 24 weeks, 24 weeks |
| Sponsor/Collaborators: | Sponsor: Novartis |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 404 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2008-12 |
| Completion Date: | 2009-12 |
| Results First Posted: | |
| Last Update Posted: | 2016-11-18 |
| Locations: | China-Japan Friendship Hospital, Beijing, China|General Hospital of Beijing Military Region of PLA, Beijing, China|Peking Union Medical College Hospital, Beijing, China|Peking University First Hospital, Beijing, China|The General Hospital of the PLA, Beijing, China|The General Hospital of the Second Artilleryman of PLA, Beijing, China|The Affiliated Union Hospital of Fujian Medical University, Fuzhou, China|The Fuzhou General Hospital of the PLA Nanjing Military Area, Fuzhou, China|Guangdong Provincial People's Hospital, Guangzhou, China|Second Affiliated Hospital of Nanchang University, Nanchang, China|The Jiangxi Provincial People's Hospital, Nanchang, China|Te Affiliated Drum Tower of Nanjing University Medical School, Nanjing, China|Tongji Hospital of Tongji University, Nanjing, China|Shanghai Changzheng Hospital, Shanghai, China|The Second Affiliated Hospital of China Medical University, Shenyang, China|The Second Affiliated Hospital of Tianjin Medical University, Tianjin, China|First Affiliated Hospital of 4th Military Medical University, Xi'an, China |
| URL: | https://clinicaltrials.gov/show/NCT00822211 |
