NCT00102466

Brief Summary

This study is not being conducted in the United States. 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 vildagliptin, an unapproved drug, compared to that of gliclazide in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
1,007

participants targeted

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

Timeline
Completed

Started Jan 2005

Longer than 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
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 17, 2020

Status Verified

May 1, 2017

Enrollment Period

4 years

First QC Date

January 29, 2005

Last Update Submit

December 11, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

type 2 diabetesvildagliptin

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in HbA1c at 52 weeks

    52 weeks

Secondary Outcomes (5)

  • Adverse event profile after 52 weeks of treatment

    52 weeks

  • Change from baseline in fasting plasma glucose at 52 weeks

    52 weeks

  • Patients with endpoint HbA1c <7% at 52 weeks

    52 weeks

  • Patients with reduction in HbA1c >/= 0.7% after 52 weeks

    52 weeks

  • Patients with reduction in HbA1c >/= 0.5% after 52 weeks

    52 weeks

Study Arms (2)

Vildagliptin

EXPERIMENTAL
Drug: vildagliptinDrug: Metformin

Gliclazide

ACTIVE COMPARATOR
Drug: GliclazideDrug: Metformin

Interventions

vildagliptinDRUG
Vildagliptin
GliclazideDRUG
Gliclazide
MetforminDRUG
GliclazideVildagliptin

Eligibility Criteria

Age18 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • On a stable dose of metformin as defined by the protocol
  • Blood glucose criteria must be met
  • Body mass index (BMI) in the range 22-45

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Investigative Centers

Nuremberg, Germany

Location

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

VildagliptinGliclazideMetformin

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 CompoundsBiguanidesGuanidinesAmidines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, 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

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 17, 2020

Record last verified: 2017-05

Locations

DE(1)CH(1)