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Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

vildagliptin

About this trial

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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

Inclusion Criteria: Blood glucose criteria must be met On a stable dose of insulin as defined by the protocol Body mass inde (BMI) in the range 22-45 Exclusion Criteria: Type 1 diabetes Pregnancy or lactation Evidence of serious diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol Other protocol defined exclusion criteria may apply

Sites / Locations

Novartis Investigative Site

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c at 24 weeks

Secondary Outcome Measures

Change from baseline in fasting plasma glucose at 24 weeks

Adverse event profile after 24 weeks of treatment

Change from baseline in mean daily insulin dose at 24 weeks

Change from baseline in mean daily number of insulin injections at 24 weeks

Patients with endpoint <7% after 24 weeks

Full Information

NCT ID

NCT00099931

First Posted

December 21, 2004

Last Updated

May 4, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00099931

Brief Title

Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Official Title

Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone.

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

254 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

vildagliptin

Primary Outcome Measure Information:

Title

Change from baseline in HbA1c at 24 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in fasting plasma glucose at 24 weeks

Title

Adverse event profile after 24 weeks of treatment

Title

Change from baseline in mean daily insulin dose at 24 weeks

Title

Change from baseline in mean daily number of insulin injections at 24 weeks

Title

Patients with endpoint <7% after 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Eligibility Criteria

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

Novartis Investigative Site

City

Investigative Sites

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

17387446

Citation

Fonseca V, Schweizer A, Albrecht D, Baron MA, Chang I, Dejager S. Addition of vildagliptin to insulin improves glycaemic control in type 2 diabetes. Diabetologia. 2007 Jun;50(6):1148-55. doi: 10.1007/s00125-007-0633-0. Epub 2007 Mar 27.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

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