Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
This study has been completed.
Sponsor:
Novartis
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00822211
First received: January 13, 2009
Last updated: May 4, 2012
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Vildagliptin 50 mg bid Drug: Vildagliptin 50 mg qd Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change from baseline in HbA1c after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent of patients with HbA1c < 7% after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Adverse event profile after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
- Change from baseline in fasting plasma glucose at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 404 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vildagliptin Dose 1 | Drug: Vildagliptin 50 mg bid |
| Experimental: Vildagliptin Dose 2 | Drug: Vildagliptin 50 mg qd |
| Placebo Comparator: Placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822211
Locations
| China | |
| The General Hospital of the PLA | |
| Beijing, China | |
| Peking University First Hospital | |
| Beijing, China | |
| Peking Union Medical College Hospital | |
| Beijing, China | |
| China-Japan Friendship Hospital | |
| Beijing, China | |
| General Hospital of Beijing Military Region of PLA | |
| Beijing, China | |
| The General Hospital of the Second Artilleryman of PLA | |
| Beijing, China | |
| The Fuzhou General Hospital of the PLA Nanjing Military Area | |
| Fuzhou, China | |
| The Affiliated Union Hospital of Fujian Medical University | |
| Fuzhou, China | |
| Guangdong Provincial People's Hospital | |
| Guangzhou, China | |
| The Jiangxi Provincial People's Hospital | |
| Nanchang, China | |
| Second Affiliated Hospital of Nanchang University | |
| Nanchang, China | |
| Tongji Hospital of Tongji University | |
| Nanjing, China | |
| Te Affiliated Drum Tower of Nanjing University Medical School | |
| 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 | |
Sponsors and Collaborators
Novartis
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00822211 History of Changes |
| Other Study ID Numbers: | CLAF237A23140 |
| Study First Received: | January 13, 2009 |
| Last Updated: | May 4, 2012 |
| Health Authority: | China: Food and Drug Administration China: Ethics Committee |
Keywords provided by Novartis:
|
Diabetes Mellitus HbA1c reduction vildagliptin add-on to metformin Chinese patients |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Vildagliptin Metformin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013