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Extension to a Study on the 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
ClinicalTrials.gov Identifier:
NCT00138554
First received: August 27, 2005
Last updated: May 3, 2012
Last verified: May 2012
History of Changes

August 27, 2005
May 3, 2012
November 2004
July 2006   (final data collection date for primary outcome measure)
  • Safety of vildagliptin in combination with pioglitazone during 52 weeks of treatment
  • Change from baseline in HbA1c at 52 weeks
Not Provided
Complete list of historical versions of study NCT00138554 on ClinicalTrials.gov Archive Site
  • Change in HbA1c between 24 weeks and 52 weeks
  • Change from baseline in fasting plasma glucose at 52 weeks
  • Change in fasting plasma glucose between 24 weeks and 52 weeks
  • Change from baseline in HOMA B at 52 weeks
  • Change from baseline in HOMA IR at 52 weeks
Not Provided
Not Provided
Not Provided
 
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study 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 pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: vildagliptin
  • Drug: pioglitazone
    pioglitazone 45 mg qd
  • Experimental: vildagliptin 50 mg qd + pioglitazone 45 mg qd
    vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks
    Interventions:
    • Drug: vildagliptin
    • Drug: pioglitazone
  • Experimental: vildagliptin 50 mg bd+ pioglitazone 45 mg qd
    vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks
    Interventions:
    • Drug: vildagliptin
    • Drug: pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
318
July 2006
July 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Only patients successfully completing study CLAF237A2304 are eligible
  • Written informed consent
  • Ability to comply with all study requirements

Exclusion Criteria:

  • Premature discontinuation from study CLAF237A2304
  • Other protocol-defined exclusion criteria may apply
Both
18 Years to 80 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00138554
CLAF237A2304E1
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP