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Efficacy and Long-Term Safety of Vildagliptin as Monotherapy in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00821977
First Posted: January 14, 2009
Last Update Posted: January 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM by assessing changes in HbA1c from baseline to 24 weeks. [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Measure: To evaluate the efficacy of vildagliptin as monotherapy in patients with T2DM as measured by changes in fasting plasma glucose from baseline to 24 weeks [ Time Frame: 24 weeks ]
  • Measure: To evaluate the safety and tolerability of vildagliptin compared to placebo over 24 weeks of treatment as monotherapy in patients with T2DM [ Time Frame: 24 weeks ]
  • Measure: To evaluate the long-term safety and tolerability of vildagliptin over the entire study duration as monotherapy in patients with T2DM [ Time Frame: 76 weeks ]
  • Measure: To evaluate the body weight change from baseline with vildagliptin compared to placebo after 24 weeks of treatment as monotherapy in patients with T2DM [ Time Frame: 24 weeks ]

Enrollment: 338
Study Start Date: November 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin Dose 1 Drug: Vildagliptin
Experimental: Vildagliptin Dose 2 Drug: Vildagliptin
Placebo Comparator: Placebo Drug: Placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at least 18 years of age at Visit 1
  • Drug naïve patients with T2DM diagnosed at least 2 months prior to Visit 1
  • HbA1c ≥ 7.0 % and ≤ 10.0% at Visit 1
  • Body Mass Index (BMI) in the range of 22-45 kg/m2 at Visit 1

Exclusion Criteria:

  • Pregnant or lactating female
  • FPG ≥ 270 mg/dL (≥15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
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): NCT00821977


  Show 176 Study Locations
Sponsors and Collaborators
Novartis
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00821977     History of Changes
Other Study ID Numbers: CLAF237B2201
First Submitted: January 13, 2009
First Posted: January 14, 2009
Last Update Posted: January 4, 2013
Last Verified: May 2012

Keywords provided by Novartis:
Type 2 Diabetes
Vildagliptin

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