Efficacy of Fixed Combination Therapy of Vildagliptin and Metformin Compared to the Individual Monotherapy Components 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:
NCT00382096
First received: September 26, 2006
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

The purpose of this study is to evaluate the efficacy and safety of a fixed combination of vildagliptin and metformin in lowering blood glucose in patients with type 2 diabetes


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin
Drug: Metformin
Drug: Vildagliptin + Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active-controlled, Multicenter Study to Compare the Effect of 24 Weeks Treatment With a Fixed Combination Therapy of Vildagliptin and Metformin to the Individual Monotherapy Components in Drug Naive Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
  • Percent of patients with endpoint HbA1c <7% [ Time Frame: At week 24 ] [ Designated as safety issue: Yes ]
  • Percent of patients with reduction in HbA1c >/=0.7% [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
  • Adverse event profile after treatment [ Time Frame: At week 24 ] [ Designated as safety issue: Yes ]
  • Change from baseline in body weight [ Time Frame: At week 24 ] [ Designated as safety issue: No ]

Enrollment: 1179
Study Start Date: September 2006
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin + Metformin Dose 1 Drug: Vildagliptin + Metformin
Experimental: Vildagliptin + Metformin Dose 2 Drug: Vildagliptin + Metformin
Active Comparator: Vildagliptin Drug: Vildagliptin
Active Comparator: Metformin Drug: Metformin

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes
  • Diagnosis of T2DM for at least 4 weeks prior to study entry
  • Age 18 - 78 years inclusive
  • Body mass index (BMI) of 22 - 40 kg/m2
  • HbA1c: 7.5 - 11% inclusive
  • FPG <270 mg/dL (15 mmol/L)

Exclusion Criteria

  • Pregnant or lactating female
  • A history of type 1 diabetes
  • Evidence of significant diabetic complications
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00382096

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany
Investigative Centers, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00382096     History of Changes
Other Study ID Numbers: CLMF237A2302
Study First Received: September 26, 2006
Last Updated: January 2, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin
metformin
hemoglobin A1c

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 April 14, 2014