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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.
Information provided by:
Novartis Identifier:
First received: July 11, 2006
Last updated: November 16, 2016
Last verified: November 2016
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Safety of vildagliptin in combination with metformin during 24 weeks of treatment [ Time Frame: 24 weeks ]
  • Change from baseline in fasting plasma glucose at 24 weeks [ Time Frame: 24 weeks ]
  • Patients with endpoint HbA1c < 7% after 24 weeks [ Time Frame: 24 weeks ]
  • Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks [ Time Frame: 24 weeks ]
  • Change from baseline in body weight at 24 weeks [ Time Frame: 24 weeks ]

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


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

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
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Please refer to this study by its identifier: NCT00351884

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

Additional Information:
Responsible Party: External Affairs, Novartis Pharmaceuticals Corporation Identifier: NCT00351884     History of Changes
Other Study ID Numbers: CLAF237A23103
Study First Received: July 11, 2006
Last Updated: November 16, 2016

Keywords provided by Novartis:
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 September 20, 2017