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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: vildagliptin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 78 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Vildagliptin 100 mg qd | Drug: vildagliptin<br>* vildagliptin 100 mg<br>* Other names: Galvus;|
| Placebo Comparator: 2<br>Matching placebo | Drug: Placebo<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in C-peptide IAUC (0-4hr) |  | 2 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 insulin |  | after two weeks of treatment | 
| Change in postprandial glucagon |  | after two weeks of treatment | 
| Change in postprandial GLP-1 |  | after 2 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, vildagliptin, incretin effect, metformin