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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
vildagliptin
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, vildagliptin, incretin effect, metformin

Eligibility Criteria

30 Years - 78 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Diabetes Zentrum Bad Lauterberg
  • Novartis Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Vildagliptin 100 mg qd

Matching placebo

Outcomes

Primary Outcome Measures

Change in C-peptide IAUC (0-4hr)

Secondary Outcome Measures

Change in insulin secretion rate (ISR) relative to glucose (0-2hr)
Change in postprandial C-peptide
Change in postprandial insulin
Change in postprandial glucagon
Change in postprandial GLP-1

Full Information

First Posted
November 2, 2006
Last Updated
November 16, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00396071
Brief Title
Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Type 2 diabetes, vildagliptin, incretin effect, metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Vildagliptin 100 mg qd
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
vildagliptin
Other Intervention Name(s)
Galvus
Intervention Description
vildagliptin 100 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Change in C-peptide IAUC (0-4hr)
Time Frame
2 weeks after treatment
Secondary Outcome Measure Information:
Title
Change in insulin secretion rate (ISR) relative to glucose (0-2hr)
Time Frame
after 2 weeks of treatment
Title
Change in postprandial C-peptide
Time Frame
after two weeks of treatment
Title
Change in postprandial insulin
Time Frame
after two weeks of treatment
Title
Change in postprandial glucagon
Time Frame
after two weeks of treatment
Title
Change in postprandial GLP-1
Time Frame
after 2 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
78 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Diabetes Zentrum Bad Lauterberg
City
Bad Lauterberg
ZIP/Postal Code
37431
Country
Germany
Facility Name
Novartis Pharmaceuticals
City
Basel
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21239518
Citation
Vardarli I, Nauck MA, Kothe 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 in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011 Apr;96(4):945-54. doi: 10.1210/jc.2010-2178. Epub 2011 Jan 14.
Results Reference
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Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin

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