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Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
University of Oslo School of Pharmacy
ClinicalTrials.gov Identifier:
NCT00319189
First received: April 27, 2006
Last updated: May 9, 2006
Last verified: April 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Renal Transplant Recipients
Posttransplant Diabetes Mellitus
Posttransplant Impaired Glucose Tolerance
 Drug: Nateglinide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nateglinide Treatment in Renal Treatment Recipients With Post Transplant Diabetes Mellitus or Impaired Glucose Tolerance

Resource links provided by NLM:

Drug Information available for: Nateglinide
U.S. FDA Resources

Further study details as provided by University of Oslo School of Pharmacy:

Primary Outcome Measures:
  • Glucose tolerance
  • Insuline release

Secondary Outcome Measures:
  • Glucose oxidation
  • Postprandial hyperlipidemia
  • Glomerular filtration rate
  • HbA1C
  • Fasting glucose
  • Plasma nitric oxide
  • Plasma endothelin-1

Estimated Enrollment: 15
Study Start Date: November 2002
Estimated Study Completion Date: November 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319189

Locations
Norway
Rikshospitalet, Section of Nephrology
Oslo, Norway, 0027
Sponsors and Collaborators
University of Oslo School of Pharmacy
Investigators
Principal Investigator: Trond Jenssen, MD, PhD Rikshospitalet, Section of Nephrology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00319189     History of Changes
Other Study ID Numbers: Starlix in RTR
Study First Received: April 27, 2006
Last Updated: May 9, 2006
Health Authority: Norway: Directorate of Health

Keywords provided by University of Oslo School of Pharmacy:
Nateglinide
Renal
Kidney
 Transplantation
Diabets
Glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperglycemia
Nateglinide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013