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Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

NCT ID: NCT00319189

Last Updated: 2006-05-10

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

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2003-11-30

Brief Summary

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The objective of the present study is to evaluate both the efficacy and safet of nateglinide in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose tolerance. Primarily will the change in glucose tolerance and acute insuline responce be addressed.

Detailed Description

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Conditions

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Renal Transplant Recipients Posttransplant Diabetes Mellitus Posttransplant Impaired Glucose Tolerance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Nateglinide

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Reduced glucose tolerance (fasting glucose \< 6.1 mmol/L AND 2 hour glucose between 6.7 and 9.9 mmol/L) or posttransplant diabetes mellitus (fasting glucose \> 6.1 mmol/L OR 2 hour glucose between \>= 10.0 mmol/L)
* Stable patients fgollowing renal transplantation, less than 25% variation in serum creatinine last week and serum creatinine \< 200 micromol/L

Exclusion Criteria

* Patients with indulin dependent diabetes mellitus before or after transplantation
* Planned change in daily prednisolone dose during the study period
* Haemoglobin \< 8g/dL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo School of Pharmacy

OTHER

Sponsor Role lead

Principal Investigators

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Trond Jenssen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rikshospitalet, Section of Nephrology

Locations

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Rikshospitalet, Section of Nephrology

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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Starlix in RTR

Identifier Type: -

Identifier Source: org_study_id