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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Placebo; Drug: vildagliptin

• Registration Number: NCT00396071
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2006-11-02
• Study First Submitted QC: 2006-11-02
• Study First Posted: 2006-11-06
• Primary Completion: 2007-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	Matching placebo
1	vildagliptin	Vildagliptin 100 mg qd

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Diabetes Zentrum Bad Lauterberg; 🇩🇪 Bad Lauterberg, Germany

Novartis Pharmaceuticals; 🇨🇭 Basel, Switzerland