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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00396071

Enrollment

Registered

2006-11-06

Start date

2006-10-31

Completion date

Unknown

Last updated

2016-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes, vildagliptin, incretin effect, metformin

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.

Interventions

DRUGvildagliptin

vildagliptin 100 mg

DRUGPlacebo

matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to 78 Years

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/

Design outcomes

Primary

Measure	Time frame
Change in C-peptide IAUC (0-4hr)	2 weeks after treatment

Secondary

Measure	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

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026