Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01426802
First received: July 1, 2011
Last updated: August 30, 2011
Last verified: August 2011

July 1, 2011
August 30, 2011
October 2010
April 2011   (final data collection date for primary outcome measure)
Evaluate the safety and tolerability of vildagliptin 50 mg bid [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Efficacy of vildagliptin based on the reduction in mean HbA1c and mean fasting plasma glucose with vildagliptin treatment at 12 weeks. Safety is measured by monitoring lipids profile, liver and kidney function to assess vildagliptin safety.
Same as current
Complete list of historical versions of study NCT01426802 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin
A 12 Week Multi Center, Open Label, Single Arm Study to Assess the Safety and Efficacy of Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
Drug: vildagliptin
Drug 50mg vildagliptin bid
Experimental: Vildagliptin 50 bid
Intervention: Drug: vildagliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who sign the informed consent
  • HbA1c in the range of > 7 to ≤10.5% at Visit 1
  • Ability to comply with all study requirements

Exclusion Criteria:

  • Pregnant or lactating women
  • Serious cardiovascular disorders
  • Liver/renal disease or dysfunction
  • Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin
  • Laboratories values abnormalities as defined by the protocol
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01426802
CLAF237AEG01
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2011

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