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Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00101712
First received: January 12, 2005
Last updated: May 4, 2012
Last verified: May 2012

January 12, 2005
May 4, 2012
October 2004
May 2006   (final data collection date for primary outcome measure)
Change from baseline in HbA1c at 52 weeks
Blood glucose levels
Complete list of historical versions of study NCT00101712 on ClinicalTrials.gov Archive Site
  • Adverse event profile after 52 weeks of treatment
  • Patients with HbA1c <6.5% at 12 weeks
  • Patients with HbA1c <6.5% at 52 weeks
  • Change from baseline in fasting plasma glucose at 52 weeks
  • Coefficient of failure for HbA1c between 24 weeks and 52 weeks
Not Provided
Not Provided
Not Provided
 
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia
Efficacy and Safety of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes and Mild Hyperglycemia

This study is not being conducted in the United States. Key long-term clinical studies have shown that people with type 2 diabetes should try to achieve overall blood glucose levels as close to normal as possible. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to placebo 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 and whose blood glucose levels are close to normal.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: vildagliptin
    Other Name: LAF237
  • Drug: Vildagliptin Placebo
  • Experimental: Vildagliptin
    Intervention: Drug: vildagliptin
  • Placebo Comparator: Placebo
    Intervention: Drug: Vildagliptin Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
274
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Blood glucose criteria must be met
  • Not currently on drug therapy for type 2 diabetes
  • Body mass index (BMI) in the range 22-45
  • Diagnosis of type 2 diabetes for at least 8 weeks

Exclusion Criteria:

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of serious diabetic complications
  • Evidence of serious cardiovascular complications
  • Significant laboratory 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
 
NCT00101712
CLAF237A2307
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
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