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Efficacy and Safety of Vildagliptin Compared to Gliclazide 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

Gliclazide

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 22-45 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 Investigative Site
Novartis Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vildagliptin

Gliclazide

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c at 104 weeks

Secondary Outcome Measures

Adverse event profile at 104 weeks

Change from baseline in fasting plasma glucose at 104 weeks

Patients with endpoint HbA1c <7% after 104 weeks

Patients with reduction in HbA1c >/= 0.7% after 104 weeks

Patients with reduction in HbA1x >/= 0.5% after 104 weeks

Full Information

NCT ID

NCT00102388

First Posted

January 29, 2005

Last Updated

November 16, 2016

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00102388

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

undefined (undefined)

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 gliclazide 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

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

1092 (Actual)

8. Arms, Groups, and Interventions

Arm Title

vildagliptin

Arm Type

Experimental

Arm Title

Gliclazide

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

vildagliptin

Intervention Type

Drug

Intervention Name(s)

Gliclazide

Primary Outcome Measure Information:

Title

Change from baseline in HbA1c at 104 weeks

Time Frame

104 weeks

Secondary Outcome Measure Information:

Title

Adverse event profile at 104 weeks

Time Frame

104 weeks

Title

Change from baseline in fasting plasma glucose at 104 weeks

Time Frame

104 weeks

Title

Patients with endpoint HbA1c <7% after 104 weeks

Time Frame

104 weeks

Title

Patients with reduction in HbA1c >/= 0.7% after 104 weeks

Time Frame

104 weeks

Title

Patients with reduction in HbA1x >/= 0.5% after 104 weeks

Time Frame

104 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 Investigative Site

City

Investigative Centers

Country

Germany

Facility Name

Novartis Pharmaceuticals

City

Basel

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

19705345

Citation

Foley JE, Sreenan S. Efficacy and safety comparison between the DPP-4 inhibitor vildagliptin and the sulfonylurea gliclazide after two years of monotherapy in drug-naive patients with type 2 diabetes. Horm Metab Res. 2009 Dec;41(12):905-9. doi: 10.1055/s-0029-1234042. Epub 2009 Aug 24. Erratum In: Horm Metab Res. 2009 Dec;41(12):909.

Results Reference

result

PubMed Identifier

21537424

Citation

Filozof C, Schwartz S, Foley JE. Effect of vildagliptin as add-on therapy to a low-dose metformin. World J Diabetes. 2010 Mar 15;1(1):19-26. doi: 10.4239/wjd.v1.i1.19.

Results Reference

result

PubMed Identifier

19221978

Citation

Goodman M, Thurston H, Penman J. Efficacy and tolerability of vildagliptin in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Horm Metab Res. 2009 May;41(5):368-73. doi: 10.1055/s-0028-1104604. Epub 2009 Feb 16.

Results Reference

result

Learn more about this trial

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

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