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

Novartis Pharmaceuticals2 sites in 2 countries22 target enrollmentOctober 2006

ConditionsDiabetes Mellitus, Type 2

Interventionsvildagliptin Placebo

Drugsvildagliptin Placebo

Overview

Phase: Phase 3
Intervention: vildagliptin
Conditions: Diabetes Mellitus, Type 2
Sponsor: Novartis Pharmaceuticals
Enrollment: 22
Locations: 2
Primary Endpoint: Change in C-peptide IAUC (0-4hr)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

November 2007

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility 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

Arms & Interventions

1

Vildagliptin 100 mg qd

Intervention: vildagliptin

2

Matching placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in C-peptide IAUC (0-4hr)

Time Frame: 2 weeks after treatment

Secondary Outcomes

Change in postprandial insulin(after two weeks of treatment)
Change in postprandial GLP-1(after 2 weeks of treatment)
Change in insulin secretion rate (ISR) relative to glucose (0-2hr)(after 2 weeks of treatment)
Change in postprandial C-peptide(after two weeks of treatment)
Change in postprandial glucagon(after two weeks of treatment)