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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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: September 26, 2006
Last updated: May 15, 2017
Last verified: May 2017
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
Intervention Model: Parallel Assignment
Masking: Participant, 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 ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: At week 24 ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose [ Time Frame: At week 24 ]
  • Percent of patients with endpoint HbA1c <7% [ Time Frame: At week 24 ]
  • Percent of patients with reduction in HbA1c >/=0.7% [ Time Frame: At week 24 ]
  • Adverse event profile after treatment [ Time Frame: At week 24 ]
  • Change from baseline in body weight [ Time Frame: At week 24 ]

Enrollment: 1179
Study Start Date: September 2006
Study Completion Date: June 3, 2008
Primary Completion Date: June 3, 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


Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00382096

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

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00382096     History of Changes
Other Study ID Numbers: CLMF237A2302
Study First Received: September 26, 2006
Last Updated: May 15, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Type 2 diabetes
hemoglobin A1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017