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Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00390520
First received: October 19, 2006
Last updated: July 13, 2009
Last verified: July 2009
History of Changes
  Purpose

This mechanistic study is designed to investigate the effect of vildagliptin on the sensitivity of the a-cell to glucose under hypoglycemic conditions in patients with type 2 diabetes (T2DM).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Effect of Vildagliptin on Glucagon Counterregulatory Response During Hypoglycemia in Patients With Type 2 Diabetes.

Resource links provided by NLM:

Drug Information available for: Glucagon
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Glucagon counterregulatory response to hypoglycemia of the last 30 min of the 2.5 mM hypoglycemic clamp after 4 weeks treatment

Secondary Outcome Measures:
  • Glucagon counterregulatory response to hypoglycemia assessed as glucagon Cmax of the 2.5 mM hypoglycemic clamp step after 4 weeks treatment
  • The 'insulin secretion rate relative to glucose' at the hypoglycemic clamp step after 4 weeks treatment
  • Change from baseline on hemoglobinA1c (HbA1c)and fasting plasma glucose
  • Safety based primarily on frequency of adverse events, number of notable abnormal laboratory values, and frequency and severity of hypoglycemic events

Estimated Enrollment: 28
Study Start Date: September 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
  Eligibility

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

Inclusion Criteria:

  • Patients with T2DM, diagnosed at least 6 weeks prior to visit 1, who have had no treatment with oral antidiabetic agents for at least 12 weeks prior to study entry (visit 1) and no treatment with oral antidiabetic agents at any time in the past for > 3 consecutive months
  • >/= 18 years
  • Body mass index in the range of 22-35 kg/m2
  • HbA1c </=7.5%

Exclusion Criteria:

  • Type 1 diabetes
  • Acute metabolic diabetic complications
  • Evidence of significant diabetic complications
  • Insulin treatment within the past 6 months

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390520

Locations
Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00390520     History of Changes
Other Study ID Numbers: CLAF237A2386
Study First Received: October 19, 2006
Last Updated: July 13, 2009
Health Authority: Sweden: Medical Products Agency

Keywords provided by Novartis:
Type 2 diabetes
vildagliptin
glucagon
hypoglycemia

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

ClinicalTrials.gov processed this record on May 22, 2013