Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822211
• Other study ID #: CLAF237A23140
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2009
• Last updated: November 16, 2016
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vildagliptin 50 mg bid

• Vildagliptin 50 mg qd

• Placebo

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

China, 

References & 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):73 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c after 24 weeks		24 weeks	No
Secondary	Percent of patients with HbA1c < 7% after 24 weeks		24 weeks	No
Secondary	Adverse event profile after 24 weeks of treatment		24 weeks	Yes
Secondary	Change from baseline in fasting plasma glucose at 24 weeks		24 weeks	No

External Links

•   Results for CLAF237A23140 from the Novartis Clinical Trials website