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Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 3

Locations

Switzerland

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

Inclusion Criteria: Not currently on drug therapy for type 2 diabetes Body mass index (BMI) in the range 20-40 Blood glucose criteria must be met Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of significant diabetic complications Evidence of serious cardiovascular conditions 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 at 24 weeks

Secondary Outcome Measures

Change from baseline in HbA1c at 24 weeks for subset of Chinese patients

Overall adverse event profile after 24 weeks of treatment

Gastrointestinal side effect profiles after 24 weeks of treatment

Change from baseline in fasting plasma glucose at 24 weeks

Patients with endpoint HbA1c <7% after 24 weeks

Full Information

NCT ID

NCT00110240

First Posted

May 4, 2005

Last Updated

May 4, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00110240

Brief Title

Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

Official Title

Efficacy and Safety of Vildagliptin Compared to Acarbose 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

April 2005 (undefined)

Primary Completion Date

October 2006 (Actual)

Study Completion Date

October 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to acarbose in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

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

594 (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 HbA1c at 24 weeks for subset of Chinese patients

Title

Overall adverse event profile after 24 weeks of treatment

Title

Gastrointestinal side effect profiles after 24 weeks of treatment

Title

Change from baseline in fasting plasma glucose at 24 weeks

Title

Patients with endpoint HbA1c <7% after 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 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

Basel

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

18341596

Citation

Pan C, Yang W, Barona JP, Wang Y, Niggli M, Mohideen P, Wang Y, Foley JE. Comparison of vildagliptin and acarbose monotherapy in patients with Type 2 diabetes: a 24-week, double-blind, randomized trial. Diabet Med. 2008 Apr;25(4):435-41. doi: 10.1111/j.1464-5491.2008.02391.x. Epub 2008 Mar 13.

Results Reference

derived

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Efficacy and Safety of Vildagliptin Compared to Acarbose in Drug Naive Patients With Type 2 Diabetes

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