Efficacy and Safety of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00390520

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 III

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Glucagon Vildagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacodynamics Study
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.

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

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

More Information

Study ID Numbers:	CLAF237A2386
Study First Received:	October 19, 2006
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00390520
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Novartis:

Type 2 diabetes
vildagliptin
glucagon
hypoglycemia

Study placed in the following topic categories:

Metabolic Diseases
Glucagon
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Vildagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009