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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: vildagliptin
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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.


Enrollment: 150
Study Start Date: October 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin 50 bid Drug: vildagliptin
Drug 50mg vildagliptin bid

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426802

Locations
Egypt
Investigative site
Cairo, Egypt
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01426802     History of Changes
Other Study ID Numbers: CLAF237AEG01
Study First Received: July 1, 2011
Last Updated: August 30, 2011
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Novartis:
metformin
vildagliptin
T2DM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013