|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00319189 |
|
Date of registration:
|
27/04/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients
|
|
Scientific title:
|
Efficacy and Safety of Nateglinide Treatment in Renal Treatment Recipients With Post Transplant Diabetes Mellitus or Impaired Glucose Tolerance |
|
Date of first enrolment:
|
November 2002 |
|
Target sample size:
|
15 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00319189 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
Norway
| | | | | | | |
|
Contacts
|
|
Name:
|
Trond Jenssen, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rikshospitalet, Section of Nephrology |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Renal Transplant Recipients
|
|
Posttransplant Diabetes Mellitus
|
|
Posttransplant Impaired Glucose Tolerance
|
|
Intervention(s)
|
|
Drug: Nateglinide
|
|
Primary Outcome(s)
|
|
Insuline release
|
|
Glucose tolerance
|
|
Secondary Outcome(s)
|
|
Glomerular filtration rate
|
|
Glucose oxidation
|
|
Postprandial hyperlipidemia
|
|
Fasting glucose
|
|
Plasma endothelin-1
|
|
HbA1C
|
|
Plasma nitric oxide
|
|
Secondary ID(s)
|
|
Starlix in RTR
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|