Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00099853
First received: December 21, 2004
Last updated: January 2, 2013
Last verified: January 2013
  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 safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Drug: pioglitazone
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Vildagliptin in Combination With Pioglitazone 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 after 24 weeks

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose at 24 weeks
  • Patients with endpoint HbA1c <7% after 24 weeks
  • Patients with reduction in HbA1c >/= to 0.7% after 24 weeks
  • Adverse event profile after 24 weeks of treatment
  • Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c

Enrollment: 362
Study Start Date: May 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin 50 mg qd + pioglitazone 45 mg qd
Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks
Drug: Vildagliptin
Vildagliptin 50 mg tablets
Other Names:
  • LAF237
  • Galvus
Drug: pioglitazone
pioglitazone 45 mg qd
Experimental: Vildagliptin 50 mg bid + pioglitazone 45 mg qd
Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks
Drug: Vildagliptin
Vildagliptin 50 mg tablets
Other Names:
  • LAF237
  • Galvus
Drug: pioglitazone
pioglitazone 45 mg qd
Placebo Comparator: Vildagliptin placebo + pioglitazone 45 mg qd
Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks
Drug: pioglitazone
pioglitazone 45 mg qd
Drug: Placebo
Vildagliptin matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Blood glucose criteria must be met
  • Previously responded, as defined by the protocol, to treatment with pioglitazone or rosiglitazone
  • Body mass index (BMI) in the range 22-45

Exclusion Criteria:

  • Type 1 diabetes
  • Pregnancy or lactation
  • Evidence of serious cardiovascular complications
  • Evidence of serious diabetic complications
  • 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: NCT00099853

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

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00099853     History of Changes
Other Study ID Numbers: CLAF237A2304
Study First Received: December 21, 2004
Last Updated: January 2, 2013
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
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 21, 2014