Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT00822211
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 404
- Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
- Agreement to maintain the same dose of metformin from randomization to the end of the study
- Age in the range of 18-78 years inclusive
- Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1
- HbA1c in the range of > 7.0 to ≤10% at Visit 1
- Agreement to maintain prior diet and exercise habits during the full course of the study
- Ability to comply with all study requirements
- Fasting Plasma Glucose (FPG) > 270 mg/dl (15 mmol/L) at Visit 1
- Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vildagliptin Dose 2 Vildagliptin 50 mg qd - Vildagliptin Dose 1 Vildagliptin 50 mg bid - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c after 24 weeks 24 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (17)
The General Hospital of the PLA
🇨🇳Beijing, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Shanghai Changzheng Hospital
🇨🇳Shanghai, China
General Hospital of Beijing Military Region of PLA
🇨🇳Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
The Affiliated Union Hospital of Fujian Medical University
🇨🇳Fuzhou, China
The Fuzhou General Hospital of the PLA Nanjing Military Area
🇨🇳Fuzhou, China
The Second Affiliated Hospital of China Medical University
🇨🇳Shenyang, China
The Second Affiliated Hospital of Tianjin Medical University
🇨🇳Tianjin, China
The Jiangxi Provincial People's Hospital
🇨🇳Nanchang, China
Te Affiliated Drum Tower of Nanjing University Medical School
🇨🇳Nanjing, China
First Affiliated Hospital of 4th Military Medical University
🇨🇳Xi'an, China
The General Hospital of the Second Artilleryman of PLA
🇨🇳Beijing, China
Tongji Hospital of Tongji University
🇨🇳Nanjing, China
Peking University First Hospital
🇨🇳Beijing, China