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

November 16, 2016 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Lauterberg, Germany, 37431
        • Diabetes Zentrum Bad Lauterberg
  • Switzerland
      • Basel, Switzerland
        • Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Vildagliptin 100 mg qd
Drug: vildagliptin
vildagliptin 100 mg
Other Names:
  • Galvus
Placebo Comparator: 2
Matching placebo
Drug: Placebo
matching placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

November 2, 2006

First Submitted That Met QC Criteria

November 2, 2006

First Posted (Estimate)

November 6, 2006

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A2387

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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