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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00822211
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : November 18, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Vildagliptin 50 mg bid Drug: Vildagliptin 50 mg qd Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin

Arm Intervention/treatment
Experimental: Vildagliptin Dose 1 Drug: Vildagliptin 50 mg bid
Experimental: Vildagliptin Dose 2 Drug: Vildagliptin 50 mg qd
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Change from baseline in HbA1c after 24 weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Percent of patients with HbA1c < 7% after 24 weeks [ Time Frame: 24 weeks ]
  2. Adverse event profile after 24 weeks of treatment [ Time Frame: 24 weeks ]
  3. Change from baseline in fasting plasma glucose at 24 weeks [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00822211

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
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
Responsible Party: Novartis Identifier: NCT00822211     History of Changes
Other Study ID Numbers: CLAF237A23140
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Novartis:
Diabetes Mellitus
HbA1c reduction
add-on to metformin
Chinese patients

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action