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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

December 21, 2004
January 2, 2013
May 2004
January 2008   (final data collection date for primary outcome measure)
Change from baseline in HbA1c after 24 weeks
Blood glucose levels
Complete list of historical versions of study NCT00099853 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
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. 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.

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
    Vildagliptin 50 mg tablets
    Other Names:
    • LAF237
    • Galvus
  • Drug: pioglitazone
    pioglitazone 45 mg qd
  • Drug: Placebo
    Vildagliptin matching placebo
  • Experimental: Vildagliptin 50 mg qd + pioglitazone 45 mg qd
    Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks
    Interventions:
    • Drug: Vildagliptin
    • Drug: pioglitazone
  • Experimental: Vildagliptin 50 mg bid + pioglitazone 45 mg qd
    Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks
    Interventions:
    • Drug: Vildagliptin
    • Drug: pioglitazone
  • Placebo Comparator: Vildagliptin placebo + pioglitazone 45 mg qd
    Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks
    Interventions:
    • Drug: pioglitazone
    • Drug: Placebo
Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007 Mar;9(2):166-74.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
362
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00099853
CLAF237A2304
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
January 2013

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