Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
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
1 other identifier
interventional
404
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 type-2-diabetes-mellitus
Started Dec 2008
Shorter than P25 for phase_3 type-2-diabetes-mellitus
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 13, 2009
CompletedFirst Posted
Study publicly available on registry
January 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedNovember 18, 2016
November 1, 2016
1 year
January 13, 2009
November 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c after 24 weeks
24 weeks
Secondary Outcomes (3)
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
Study Arms (3)
Vildagliptin Dose 1
EXPERIMENTALVildagliptin Dose 2
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Fasting Plasma Glucose (FPG) \> 270 mg/dl (15 mmol/L) at Visit 1
- Pregnant or nursing (lactating) women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (17)
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
Related Publications (1)
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.
PMID: 22369287RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2009
First Posted
January 14, 2009
Study Start
December 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
November 18, 2016
Record last verified: 2016-11