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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00822211
First received: January 13, 2009
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: Vildagliptin 50 mg bid
Drug: Vildagliptin 50 mg qd
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in HbA1c after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of patients with HbA1c < 7% after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse event profile after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in fasting plasma glucose at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 404
Study Start Date: December 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Dose 1 Drug: Vildagliptin 50 mg bid
Experimental: Vildagliptin Dose 2 Drug: Vildagliptin 50 mg qd
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00822211

Locations
China
The General Hospital of the PLA
Beijing, China
Peking University First Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
China-Japan Friendship Hospital
Beijing, China
General Hospital of Beijing Military Region of PLA
Beijing, China
The General Hospital of the Second Artilleryman of PLA
Beijing, China
The Fuzhou General Hospital of the PLA Nanjing Military Area
Fuzhou, China
The Affiliated Union Hospital of Fujian Medical University
Fuzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China
The Jiangxi Provincial People's Hospital
Nanchang, China
Second Affiliated Hospital of Nanchang University
Nanchang, China
Tongji Hospital of Tongji University
Nanjing, China
Te Affiliated Drum Tower of Nanjing University Medical School
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
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00822211     History of Changes
Other Study ID Numbers: CLAF237A23140
Study First Received: January 13, 2009
Last Updated: May 4, 2012
Health Authority: China: Food and Drug Administration
China: Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 28, 2014