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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.
 
ClinicalTrials.gov Identifier: NCT00822211
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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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 Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00822211


Locations
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Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications of Results:

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00822211    
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
vildagliptin
add-on to metformin
Chinese patients
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
 Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action