Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00351884
First received: July 11, 2006
Last updated: February 28, 2011
Last verified: February 2011
  Purpose

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Vildagliptin AM
Drug: vildagliptin pm
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • Safety of vildagliptin in combination with metformin during 24 weeks of treatment [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline in fasting plasma glucose at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patients with endpoint HbA1c < 7% after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight at 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 370
Study Start Date: May 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vildagliptin am Drug: Vildagliptin AM
Experimental: vildagliptin pm Drug: vildagliptin pm
Placebo Comparator: placebo Drug: placebo

  Eligibility

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

Inclusion Criteria:

  • Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
  • Body mass index in the range 22-40
  • Blood glucose criteria must be met

Exclusion Criteria:

  • Pregnancy or lactation
  • History of type 1 diabetes
  • Evidence of significant diabetic complications

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351884

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

Additional Information:
No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00351884     History of Changes
Other Study ID Numbers: CLAF237A23103
Study First Received: July 11, 2006
Last Updated: February 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin
Hemoglobin A1c

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

ClinicalTrials.gov processed this record on October 23, 2014