NCT00646542

Brief Summary

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
525

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
12 countries

12 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

March 1, 2005

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Last Updated

December 17, 2020

Status Verified

January 1, 2013

Enrollment Period

5.6 years

First QC Date

March 24, 2008

Last Update Submit

December 11, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes, vildagliptin

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment

    24 weeks

Secondary Outcomes (2)

  • To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency.

    24 weeks

  • To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency.

    24 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Vildagliptin

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

VildagliptinDRUG
Also known as: Galvus
1
PlaceboDRUG
2

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History T2DM
  • Moderate or Severe Renal Impairment

You may not qualify if:

  • Glucose \> 270 mg/dL (\>15 mmol/L)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Heidelberg Heights, Australia

Location

Unknown Facility

Winnipeg, Canada

Location

Unknown Facility

Cartago, Costa Rica

Location

Unknown Facility

Tampere, Finland

Location

Unknown Facility

Angers, France

Location

Unknown Facility

Dormagen, Germany

Location

Unknown Facility

Chennai, India

Location

Unknown Facility

Oslo, Norway

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Alicante, Spain

Location

Unknown Facility

Lund, Sweden

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

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

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 28, 2008

Study Start

March 1, 2005

Primary Completion

October 1, 2010

Last Updated

December 17, 2020

Record last verified: 2013-01

Locations

NO(1)IN(1)SE(1)FI(1)ES(1)RU(1)DE(1)AU(1)CA(1)AR(1)CO(1)FR(1)