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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

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ClinicalTrials.gov Identifier: NCT00382096
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : May 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Vildagliptin Drug: Metformin Drug: Vildagliptin + Metformin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : September 2006
Actual Primary Completion Date : June 3, 2008
Actual Study Completion Date : June 3, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00382096     History of Changes
Other Study ID Numbers: CLMF237A2302
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: May 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action