Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00106340
First received: March 22, 2005
Last updated: December 28, 2012
Last verified: December 2012

March 22, 2005
December 28, 2012
March 2005
May 2008   (final data collection date for primary outcome measure)
Time to HbA1c >8% [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Blood glucose levels
Complete list of historical versions of study NCT00106340 on ClinicalTrials.gov Archive Site
  • Change from baseline in HbA1c at 5 years [ Time Frame: 2 years (amended) ] [ Designated as safety issue: No ]
  • Adverse event profile after 5 years of treatment [ Time Frame: 2 years (amended) ] [ Designated as safety issue: Yes ]
  • Coefficient of failure for HbA1c from week 24 to 5 years [ Time Frame: 2 years (amended) ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose at 5 years [ Time Frame: 2 years (amended) ] [ Designated as safety issue: No ]
  • Change from baseline in body weight at 5 years [ Time Frame: 2 years (amended) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes
Vildagliptin Compared to Glimepiride in Combination With Metformin 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 long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride 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.

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
    Other Name: LAF237, Galvus
  • Drug: glimepiride
  • Drug: Metformin
  • Drug: Vildagliptin matching placebo
  • Drug: Glimepiride matching placebo
  • Experimental: Vildagliptin
    Interventions:
    • Drug: vildagliptin
    • Drug: Metformin
    • Drug: Glimepiride matching placebo
  • Active Comparator: Glimepiride
    Interventions:
    • Drug: glimepiride
    • Drug: Metformin
    • Drug: Vildagliptin matching placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3118
Not Provided
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of significant diabetic complications
  • Evidence of serious cardiovascular complications
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined exclusion criteria may apply
Both
18 Years to 73 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00106340
CLAF237A2308
Not Provided
External Affairs, Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
December 2012

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