Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation (SAPT-NODAT)
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|ClinicalTrials.gov Identifier: NCT01680185|
Recruitment Status : Unknown
Verified January 2016 by Marcus Saemann, Medical University of Vienna.
Recruitment status was: Active, not recruiting
First Posted : September 7, 2012
Last Update Posted : January 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hyperglycemia||Drug: Insulin lispro, Humalog (Eli Lilly) in insulin pump Drug: Human insulin isophane, Humulin N (Eli Lilly) Other: Standard of care||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treat-To-Target Trial of Continuous Subcutaneous, Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation (SAPT-NODAT)|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
Active Comparator: Sensor-augmented Insulin Pump
Continuous subcutaneous sensor-augmented insulin-pump therapy (SAPT) with an insulin pump from Medtronic (Paradigm® Velo) for a period of approximately 3 months post-transplantation.
Drug: Insulin lispro, Humalog (Eli Lilly) in insulin pump
all covered above
Active Comparator: Basal insulin
NPH insulin titration regimen, as specified in the IPT-NODAT study
Drug: Human insulin isophane, Humulin N (Eli Lilly)
all covered above
Active Comparator: Standard of care
Patients assigned in this arm will receive standard of care following their kidney transplantation
Other: Standard of care
all covered above
Other Name: Sliding scale short acting insulin for hyperglycemi; Sulphonylurea for NODAT
- Glycosylated hemoglobin (HbA1c) [ Time Frame: 3 months after transplantation ]HbA1c levels, in relative %, at 3 months. Superiority will be assumed if a statistically significant difference between the SAPT-treatment group versus the control group (from the ITP-NODAT study) can be determined.
- Glycosylated hemoglobin (HbA1c) [ Time Frame: 3, 6, 12, 24 months after transplantation ]HbA1c, in relative %, at 3, 6, 12 and 24 months post-transplantation; The baseline measurement will also be subtracted from the 3-, 6-, 12-, and 24-months measurement (i.e. "3-months, 6-months, 12-months, and 24-months HbA1c minus baseline HbA1c"). For the determination of the intra-individual rise in HbA1c, the previously observed rise of 0.5±0.7 % (mean ± standard deviation) from baseline to 3 months in the TIP-study basal insulin treatment group will be judged to be clinically not meaningful, hence if the intra-individual rise in the SAPT-treatment group remains below that value, the rise in HbA1c will be considered to be not meaningful, clinically.
- Oral glucose tolerance test (OGTT)-derived 2 hour-glucose [ Time Frame: 6, 12, 24 months after transplantation ]2h glucose ≥200 mg/dL, as by OGTT at 6, 12 and 24 months after transplantation (in comparison to the simultaneously monitored control group of the ITP-NODAT study [=arm B; control])
- Fasting glucose [ Time Frame: 6, 12, 24 months after transplantation ]Fasting glucose and 2h glucose at 6, 12 and 24 months after transplantation.
- Beta cell function [ Time Frame: 6, 12, 24 months after transplantation ]Insulinogenic index during an OGTT at 6, 12 and 24 months after kidney transplantation
- Insulin sensitivity [ Time Frame: 6, 12, 24 months after transplantation ]Oral glucose insulin sensitivity (OGIS) index at 6, 12 and 24 months after kidney transplantation
- Daily glucose measurements [ Time Frame: Daily glucose measurements will be obtained during the hopital stay and while patients are injecting insulin, during an expected average of 3 months. ]Daily glycemia profile, through evaluation of all available glucose measurements
- Serum creatinine [ Time Frame: 6, 12 and 24 months after transplantation ]Serum creatinine at 6, 12 and 24 months after kidney transplantation
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): NCT01680185
|Medical University of Vienna|
|Vienna, Austria, 1090|
|Principal Investigator:||Marcus D Säemann, MD||Medical University of Vienna|