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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:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00821977
First received: January 13, 2009
Last updated: January 2, 2013
Last verified: May 2012
  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: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00821977

  Show 176 Study Locations
Sponsors and Collaborators
Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00821977     History of Changes
Other Study ID Numbers: CLAF237B2201
Study First Received: January 13, 2009
Last Updated: January 2, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
India: Drugs Controller General of India
Philippines: Bureau of Food and Drugs
Malaysia: Ministry of Health
Slovakia: State Institute for Drug Control
Romania: National Medicines Agency

Keywords provided by Novartis:
Type 2 Diabetes
Vildagliptin

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 November 24, 2014