Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin - Full Text View

Purpose

This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect in patients with type 2 diabetes.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: vildagliptin Drug: Placebo	Phase III

MedlinePlus related topics:

Diabetes

Drug Information available for:

Metformin Metformin hydrochloride 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 the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in C-peptide IAUC (0-4hr) [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in insulin secretion rate (ISR) relative to glucose (0-2hr) [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: No ]
Change in postprandial C-peptide [ Time Frame: after two weeks of treatment ] [ Designated as safety issue: No ]
Change in postprandial insulin [ Time Frame: after two weeks of treatment ] [ Designated as safety issue: No ]
Change in postprandial glucagon [ Time Frame: after two weeks of treatment ] [ Designated as safety issue: No ]
Change in postprandial GLP-1 [ Time Frame: after 2 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	October 2006
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Vildagliptin 100 mg qd	Drug: vildagliptin vildagliptin 100 mg
2: Placebo Comparator Matching placebo	Drug: Placebo matching placebo

Eligibility

Ages Eligible for Study:	30 Years to 78 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
Agreement to maintain the same dose of metformin throughout the study
Body mass index (BMI) in the range of 22-35 kg/m2
HbA1c in the range of 7.0 to 9.0%
FPG <200 mg/dl (11.1 mmol/L)
Agreement to maintain prior diet and exercise habits during the full course of the study
Ability to comply with all study requirements and signed informed consent to participate in the study

Exclusion Criteria:

A history of type 1 diabetes
A history of acute metabolic diabetic complications
Evidence of significant diabetic complications
Insulin treatment for longer than 10 days within the past 6 months
Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396071

Locations


Germany
	Diabetes Zentrum Bad Lauterberg
	Bad Lauterberg, Germany, 37431

Switzerland
	Novartis Pharmaceuticals
	Basel, Switzerland

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CLAF237A2387
First Received:	November 2, 2006
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00396071
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Type 2 diabetes

vildagliptin

incretin effect

metformin

Study placed in the following topic categories:

Metabolic Diseases

Metformin

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Vildagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Enzyme Inhibitors

Pharmacologic Actions

Protease Inhibitors

ClinicalTrials.gov processed this record on October 29, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00396071