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Safety and Efficacy of Vildagliptin vs. Thiazolidinedione as add-on Therapy to Metformin in Patients With Type 2 Diabetes Not Controlled With Metformin Alone

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: NCT00396227
Recruitment Status : Completed
First Posted : November 6, 2006
Last Update Posted : November 18, 2016
Information provided by:

Brief Summary:
This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: vildagliptin Drug: thiazolidinedione (TZD) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2665 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Open-label, Active Controlled, Parallel Arm Study to Compare the Efficacy of 12 Weeks of Treatment With Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy in a Community-based Practice Setting.
Study Start Date : October 2006
Actual Primary Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Vildagliptin 100mg + Met
Drug: vildagliptin
vildagliptin as add-on to metformin
Other Name: Galvus

Active Comparator: TZD
TZD + metformin
Drug: thiazolidinedione (TZD)
TZD add-on to metformin
Other Name: Actos (pioglitazone), Avandia (rosiglitazone)

Primary Outcome Measures :
  1. Change from baseline in HemoglobinA1c (HbA1c) [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Change from baseline in body weight [ Time Frame: after 12 weeks of treatment ]
  2. Change from baseline in fasting plasma glucose (FPG) [ Time Frame: after 12 weeks of treatment ]
  3. Incidence of prespecified adverse events while on treatment with study drug [ Time Frame: 12 week treatment duration ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Patients who have received a stable dose of metformin consisting of at least 1,000 mg/day for four weeks prior to Visit 1 (week-2)
  • Agreement to maintain the same dose of metformin from screening to the end of the study
  • Age in the range of 18-80 years
  • Body mass index (BMI) in the range of 22-40 kg/m2
  • HbA1c in the range of 7.0 to 10%
  • FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria:

  • A history of type 1 diabetes
  • Liver disease
  • Treatment with insulin or any oral anti-diabetic other than metformin, within 8 weeks prior to Visit 1

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): NCT00396227

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United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications of Results:
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Responsible Party: External Affairs, Novartis Pharmaceuticals Identifier: NCT00396227    
Other Study ID Numbers: CLAF237A23119
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016
Keywords provided by Novartis:
Type 2 diabetes
hemoglobin A1c
Additional relevant MeSH terms:
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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