Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
NCT ID: NCT00822211
Last Updated: 2016-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
404 participants
INTERVENTIONAL
2008-12-31
2009-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vildagliptin Dose 1
Vildagliptin 50 mg bid
Vildagliptin Dose 2
Vildagliptin 50 mg qd
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vildagliptin 50 mg bid
Vildagliptin 50 mg qd
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Pregnant or nursing (lactating) women
18 Years
78 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Pan C, Xing X, Han P, Zheng S, Ma J, Liu J, Lv X, Lu J, Bader G; Institution Investigators. Efficacy and tolerability of vildagliptin as add-on therapy to metformin in Chinese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2012 Aug;14(8):737-44. doi: 10.1111/j.1463-1326.2012.01593.x. Epub 2012 Apr 1.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLAF237A23140
Identifier Type: -
Identifier Source: org_study_id