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

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ClinicalTrials.gov Identifier: NCT00821977
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
This is a 2-3 period parallel group study with an adaptive element in Type 2 diabetes patients receiving vildagliptin as monotherapy.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Vildagliptin Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2008
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vildagliptin Dose 1 Drug: Vildagliptin
Experimental: Vildagliptin Dose 2 Drug: Vildagliptin
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]


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


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


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Sponsors and Collaborators
Novartis

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00821977     History of Changes
Other Study ID Numbers: CLAF237B2201
First Posted: January 14, 2009    Key Record Dates
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