Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

University of Oslo School of Pharmacy

Status and phase

Completed

Phase 4

Conditions

Renal Transplant Recipients

Posttransplant Impaired Glucose Tolerance

Posttransplant Diabetes Mellitus

Treatments

Drug: Nateglinide

Study type

Interventional

Funder types

Other

Identifiers

NCT00319189

Starlix in RTR

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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