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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

United States

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 - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Blood glucose criteria must be met On a stable dose of metformin as defined by the protocol Body mass index (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 Pharmaceuticals

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c after 24 weeks

Secondary Outcome Measures

Change from baseline in fasting plasma glucose at 24 weeks

Patients with endpoint HbA1c <7% after 24 weeks

Patients with reduction in HbA1c >/=to 0.7% after 24 weeks

Change from baseline in body weight at 24 weeks

Change from baseline in fasting lipids at 24 weeks

Full Information

NCT ID

NCT00099892

First Posted

December 21, 2004

Last Updated

July 31, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00099892

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

September 2005 (Actual)

Study Completion Date

September 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 target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2 diabetes who are not at target blood glucose levels on metformin 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

544 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

vildagliptin

Primary Outcome Measure Information:

Title

Change from baseline in HbA1c after 24 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in fasting plasma glucose at 24 weeks

Title

Patients with endpoint HbA1c <7% after 24 weeks

Title

Patients with reduction in HbA1c >/=to 0.7% after 24 weeks

Title

Change from baseline in body weight at 24 weeks

Title

Change from baseline in fasting lipids at 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

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

12. IPD Sharing Statement

Citations:

PubMed Identifier

17277036

Citation

Bosi E, Camisasca RP, Collober C, Rochotte E, Garber AJ. Effects of vildagliptin on glucose control over 24 weeks in patients with type 2 diabetes inadequately controlled with metformin. Diabetes Care. 2007 Apr;30(4):890-5. doi: 10.2337/dc06-1732. Epub 2007 Feb 2.

Results Reference

derived

Learn more about this trial

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

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