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Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00319189
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : May 10, 2006
Information provided by:
University of Oslo School of Pharmacy

Brief Summary:
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 or disease Intervention/treatment Phase
Renal Transplant Recipients Posttransplant Diabetes Mellitus Posttransplant Impaired Glucose Tolerance Drug: Nateglinide Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2002
Estimated Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Glucose tolerance
  2. Insuline release

Secondary Outcome Measures :
  1. Glucose oxidation
  2. Postprandial hyperlipidemia
  3. Glomerular filtration rate
  4. HbA1C
  5. Fasting glucose
  6. Plasma nitric oxide
  7. Plasma endothelin-1

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319189

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

ClinicalTrials.gov Identifier: NCT00319189     History of Changes
Other Study ID Numbers: Starlix in RTR
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: May 10, 2006
Last Verified: April 2006

Keywords provided by University of Oslo School of Pharmacy:

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