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Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00102388
First received: January 29, 2005
Last updated: September 4, 2012
Last verified: September 2012
History of Changes

January 29, 2005
September 4, 2012
January 2005
March 2008   (final data collection date for primary outcome measure)
Change from baseline in HbA1c at 104 weeks [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Blood glucose levels
Complete list of historical versions of study NCT00102388 on ClinicalTrials.gov Archive Site
  • Adverse event profile at 104 weeks [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in fasting plasma glucose at 104 weeks [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Patients with endpoint HbA1c <7% after 104 weeks [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Patients with reduction in HbA1c >/= 0.7% after 104 weeks [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Patients with reduction in HbA1x >/= 0.5% after 104 weeks [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: vildagliptin
  • Drug: Gliclazide
  • Experimental: vildagliptin
    Intervention: Drug: vildagliptin
  • Active Comparator: Gliclazide
    Intervention: Drug: Gliclazide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1092
Not Provided
March 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Not currently on drug therapy for type 2 diabetes
  • 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 conditions
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined exclusion criteria may apply
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Switzerland
 
NCT00102388
CLAF237A2310
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2012

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