- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00822211
Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
November 16, 2016 updated by: Novartis
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
404
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Beijing, China
- Peking University First Hospital
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Beijing, China
- Peking Union Medical College Hospital
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Beijing, China
- China-Japan Friendship Hospital
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Beijing, China
- General Hospital of Beijing Military Region of PLA
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Beijing, China
- The General Hospital of the PLA
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Beijing, China
- The General Hospital of the Second Artilleryman of PLA
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Fuzhou, China
- The Affiliated Union Hospital of Fujian Medical University
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Fuzhou, China
- The Fuzhou General Hospital of the PLA Nanjing Military Area
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Guangzhou, China
- Guangdong Provincial People's Hospital
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Nanchang, China
- The Jiangxi Provincial People's Hospital
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Nanchang, China
- Second Affiliated Hospital of Nanchang University
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Nanjing, China
- Te Affiliated Drum Tower of Nanjing University Medical School
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Nanjing, China
- Tongji Hospital of Tongji University
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Shanghai, China
- Shanghai Changzheng Hospital
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Shenyang, China
- The Second Affiliated Hospital of China Medical University
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Tianjin, China
- The Second Affiliated Hospital of Tianjin Medical University
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Xi'an, China
- First Affiliated Hospital of 4th Military Medical University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Vildagliptin Dose 1
|
|
Experimental: Vildagliptin Dose 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in HbA1c after 24 weeks
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event profile after 24 weeks of treatment
Time Frame: 24 weeks
|
24 weeks
|
Percent of patients with HbA1c < 7% after 24 weeks
Time Frame: 24 weeks
|
24 weeks
|
Change from baseline in fasting plasma glucose at 24 weeks
Time Frame: 24 weeks
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
January 13, 2009
First Submitted That Met QC Criteria
January 13, 2009
First Posted (Estimate)
January 14, 2009
Study Record Updates
Last Update Posted (Estimate)
November 18, 2016
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Dipeptidyl-Peptidase IV Inhibitors
- Vildagliptin
Other Study ID Numbers
- CLAF237A23140
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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