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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396071
• Other study ID #: CLAF237A2387
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2006
• Last updated: November 16, 2016
• Start date: October 2006

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. primary completion date: November 2007
• Gender: Both
• Age group: 30 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• vildagliptin
vildagliptin 100 mg
• Placebo
matching placebo

Locations

Country	Name	City	State
Germany	Diabetes Zentrum Bad Lauterberg	Bad Lauterberg
Switzerland	Novartis Pharmaceuticals	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Germany,  Switzerland, 

References & Publications (1)

Vardarli I, Nauck MA, Köthe LD, Deacon CF, Holst JJ, Schweizer A, Foley JE. Inhibition of DPP-4 with vildagliptin improved insulin secretion in response to oral as well as "isoglycemic" intravenous glucose without numerically changing the incretin effect — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in C-peptide IAUC (0-4hr)		2 weeks after treatment	No
Secondary	Change in insulin secretion rate (ISR) relative to glucose (0-2hr)		after 2 weeks of treatment	No
Secondary	Change in postprandial C-peptide		after two weeks of treatment	No
Secondary	Change in postprandial insulin		after two weeks of treatment	No
Secondary	Change in postprandial glucagon		after two weeks of treatment	No
Secondary	Change in postprandial GLP-1		after 2 weeks of treatment	No

External Links

•   Results for CLAF237A2387 from the Novartis Clinical Trials website