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Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

International

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: Only patients successfully completing study CLAF237A2327 are eligible Written informed consent Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from study CLAF237A2327 Other protocol-defined exclusion criteria may apply

Sites / Locations

Novartis Pharmaceuticals

Outcomes

Primary Outcome Measures

Safety during 104 weeks of treatment

Change from baseline in HbA1c at 104 weeks

Secondary Outcome Measures

Change in HbA1c between 24 weeks and 104 weeks

Change from baseline in fasting plasma glucose at 104 weeks

Change in fasting plasma glucose between 24 weeks and 104 weeks

Change from baseline in HOMA B at 104 weeks

Change in HOMA B between 24 weeks and 104 weeks

Full Information

NCT ID

NCT00138619

First Posted

August 27, 2005

Last Updated

May 4, 2012

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00138619

Brief Title

Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Official Title

Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

November 2004 (undefined)

Primary Completion Date

April 2007 (Actual)

Study Completion Date

April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief Summary

This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people 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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

478 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

vildagliptin

Primary Outcome Measure Information:

Title

Safety during 104 weeks of treatment

Title

Change from baseline in HbA1c at 104 weeks

Secondary Outcome Measure Information:

Title

Change in HbA1c between 24 weeks and 104 weeks

Title

Change from baseline in fasting plasma glucose at 104 weeks

Title

Change in fasting plasma glucose between 24 weeks and 104 weeks

Title

Change from baseline in HOMA B at 104 weeks

Title

Change in HOMA B between 24 weeks and 104 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 Pharmaceuticals

City

East Hanover

State/Province

New Jersey

ZIP/Postal Code

07936

Country

United States

City

Investigative Centers

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

19383032

Citation

Rosenstock J, Niggli M, Maldonado-Lutomirsky M. Long-term 2-year safety and efficacy of vildagliptin compared with rosiglitazone in drug-naive patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 Jun;11(6):571-8. doi: 10.1111/j.1463-1326.2008.01021.x. Epub 2009 Apr 5.

Results Reference

derived

Learn more about this trial

Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

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