Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00237237
First received: October 9, 2005
Last updated: August 21, 2008
Last verified: August 2008
  Purpose

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long-term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of pioglitazone in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: vildagliptin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Vildagliptin Compared to Pioglitazone in Combination With Metformin in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in HbA1c at 52 weeks

Secondary Outcome Measures:
  • Adverse event profile after 52 weeks of treatment
  • Change from baseline in fasting plasma glucose at 52 weeks
  • Change from baseline in body weight at 52 weeks
  • Patients with endpoint HbA1c < 7% after 52 weeks
  • Patients with reduction in HbA1c >/= to 7% after 52 weeks

Estimated Enrollment: 588
Study Start Date: October 2005
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 77 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • On a stable dose of metformin as defined by the protocol
  • Blood glucose criteria must be met
  • Body mass index (BMI) in the range 22-45

Exclusion Criteria:

  • History of type 1 diabetes
  • Pregnancy or lactation
  • Evidence of significant diabetic complications
  • Serious cardiovascular events within the past 6 months
  • Laboratory value abnormalities as defined by the protocol
  • Known sensitivity to pioglitazone
  • Other protocol-defined 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: NCT00237237

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany
Investigative Centers
Nurnberg, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00237237     History of Changes
Other Study ID Numbers: CLAF237A2354
Study First Received: October 9, 2005
Last Updated: August 21, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
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 September 14, 2014