NCT00102388

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,092

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

3.2 years

First QC Date

January 29, 2005

Last Update Submit

November 16, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetesvildagliptin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c at 104 weeks

    104 weeks

Secondary Outcomes (5)

  • Adverse event profile at 104 weeks

    104 weeks

  • Change from baseline in fasting plasma glucose at 104 weeks

    104 weeks

  • Patients with endpoint HbA1c <7% after 104 weeks

    104 weeks

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

    104 weeks

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

    104 weeks

Study Arms (2)

vildagliptin

EXPERIMENTAL
Drug: vildagliptin

Gliclazide

ACTIVE COMPARATOR
Drug: Gliclazide

Interventions

vildagliptinDRUG
vildagliptin
GliclazideDRUG
Gliclazide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Not currently on drug therapy for type 2 diabetes
  • Body mass index (BMI) in the range 22-45
  • Blood glucose criteria must be met

You may not qualify if:

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of significant diabetic complications
  • Evidence of serious cardiovascular conditions
  • Laboratory value abnormalities as defined by the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Investigative Centers, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 19705345RESULT

  • 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.

    PMID: 21537424RESULT

  • 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.

    PMID: 19221978RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinGliclazide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzenesulfonamidesSulfonamidesAmidesSulfonylurea CompoundsUreaBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2005

First Posted

January 31, 2005

Study Start

January 1, 2005

Primary Completion

March 1, 2008

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

DE(1)CH(1)