Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

NCT ID: NCT00646542

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

525 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Vildagliptin

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Vildagliptin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Galvus

Eligibility Criteria

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Inclusion Criteria

* History T2DM
* Moderate or Severe Renal Impairment

Exclusion Criteria

* Glucose \> 270 mg/dL (\>15 mmol/L)
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Buenos Aires, , Argentina

Site Status

Heidelberg Heights, , Australia

Site Status

Winnipeg, , Canada

Site Status

Cartago, , Costa Rica

Site Status

Tampere, , Finland

Site Status

Angers, , France

Site Status

Dormagen, , Germany

Site Status

Chennai, , India

Site Status

Oslo, , Norway

Site Status

Saint Petersburg, , Russia

Site Status

Alicante, , Spain

Site Status

Lund, , Sweden

Site Status

Countries

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Argentina Australia Canada Costa Rica Finland France Germany India Norway Russia Spain Sweden

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4598

Results for CLAF237A23137 from the Novartis Clinical Trials website

Other Identifiers

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CLAF237A23137

Identifier Type: -

Identifier Source: org_study_id

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