Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation (SAPT-NODAT)

Study Description

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Brief Summary:

The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment with short acting insulin, applied continuously through an insulin pump, (i) improves glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers further β-cell protection, in comparison to the standard of care control group, and the basal insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic events. Patients in the SAPT-NODAT study will be followed through 24 months post-transplantation.

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

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	85 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
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

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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])
3. Fasting glucose [ Time Frame: 6, 12, 24 months after transplantation ]
   Fasting glucose and 2h glucose at 6, 12 and 24 months after transplantation.
4. 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
5. 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
6. 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
7. Serum creatinine [ Time Frame: 6, 12 and 24 months after transplantation ]
   Serum creatinine at 6, 12 and 24 months after kidney transplantation

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Adult patients with end stage renal disease undergoing kidney transplantation with a deceased or living donor kidney.
• Absence of diabetes prior to kidney transplantation, defined according to American Diabetes Association guideline (not on oral hypoglycemic agents or insulin with fasting glucose <126 mg/dL).
• Receiving standard triple immunosuppressive medications that include tacrolimus, mycophenolate mofetil or mycophenolic sodium and steroids.
• Capable of understanding the study and willing to give informed written consent for study participation.

Exclusion Criteria:

• Patients with a diagnosis of diabetes mellitus prior to kidney transplantation, or receiving anti-diabetic medications, or having pre-transplant fasting glucose level equal or greater than 126 mg/dL on two occasions at least three days apart.
• Patients receiving an organ transplant other than kidney.
• Patients receiving an unlicensed drug or therapy within one month prior to study entry.
• Patients with history of hypersensitivity to injectable insulin.
• Patients with documented HIV infection.

Contacts and Locations

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Locations

Austria
Medical University of Vienna
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:	Marcus D Säemann, MD	Medical University of Vienna

More Information

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Responsible Party:	Marcus Saemann, Prof. Dr. Marcus Säemann, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT01680185 History of Changes
Other Study ID Numbers:	SAPT-NODAT_9march2012
First Posted:	September 7, 2012
Last Update Posted:	January 28, 2016
Last Verified:	January 2016

Keywords provided by Marcus Saemann, Medical University of Vienna:

Hyperglycemia; NODAT; Insulin pump; Semiclosed loop

Additional relevant MeSH terms:

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Insulin, Globin Zinc; Isophane insulin, beef; Insulin	Insulin Lispro; Insulin, Short-Acting; Isophane Insulin, Human; Insulin, Isophane; Hypoglycemic Agents; Physiological Effects of Drugs