Clinical trial NCT00822211: Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus
HbA1c reduction
vildagliptin
add-on to metformin
Chinese patients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in HbA1c after 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Percent of patients with HbA1c < 7% after 24 weeks
timeFrame: 24 weeks
measure: Adverse event profile after 24 weeks of treatment
timeFrame: 24 weeks
measure: Change from baseline in fasting plasma glucose at 24 weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: General Hospital of Beijing Military Region of PLA
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: The General Hospital of the PLA
city: Beijing
country: China
facility: The General Hospital of the Second Artilleryman of PLA
city: Fuzhou
country: China
facility: The Affiliated Union Hospital of Fujian Medical University
city: Fuzhou
country: China
facility: The Fuzhou General Hospital of the PLA Nanjing Military Area
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Nanchang
country: China
facility: Second Affiliated Hospital of Nanchang University
city: Nanchang
country: China
facility: The Jiangxi Provincial People's Hospital
city: Nanjing
country: China
facility: Te Affiliated Drum Tower of Nanjing University Medical School
city: Nanjing
country: China
facility: Tongji Hospital of Tongji University
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
city: Shenyang
country: China
facility: The Second Affiliated Hospital of China Medical University
city: Tianjin
country: China
facility: The Second Affiliated Hospital of Tianjin Medical University
city: Xi'an
country: China
facility: First Affiliated Hospital of 4th Military Medical University
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.