Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00822211
First received: January 13, 2009
Last updated: May 4, 2012
Last verified: May 2012

January 13, 2009
May 4, 2012
December 2008
December 2009   (final data collection date for primary outcome measure)
Change from baseline in HbA1c after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00822211 on ClinicalTrials.gov Archive Site
  • Percent of patients with HbA1c < 7% after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Adverse event profile after 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in fasting plasma glucose at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of add-on Therapy With Vildagliptin in Chinese Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

The purpose of this study is to assess the efficacy and safety of vildagliptin 50 mg bid compared to placebo as an add-on therapy to metformin in Chinese patients with T2DM inadequately controlled by metformin alone.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Vildagliptin 50 mg bid
  • Drug: Vildagliptin 50 mg qd
  • Drug: Placebo
  • Experimental: Vildagliptin Dose 1
    Intervention: Drug: Vildagliptin 50 mg bid
  • Experimental: Vildagliptin Dose 2
    Intervention: Drug: Vildagliptin 50 mg qd
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
404
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with T2DM who have received metformin for at least 8 weeks and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
  • Agreement to maintain the same dose of metformin from randomization to the end of the study
  • Age in the range of 18-78 years inclusive
  • Body mass index (BMI) in the range of 20-40 kg/m2 inclusive at Visit 1
  • HbA1c in the range of > 7.0 to ≤10% at Visit 1
  • Agreement to maintain prior diet and exercise habits during the full course of the study
  • Ability to comply with all study requirements

Exclusion Criteria:

  • Fasting Plasma Glucose (FPG) > 270 mg/dl (15 mmol/L) at Visit 1
  • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Both
18 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00822211
CLAF237A23140
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