Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation - Full Text View

Purpose

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	Intervention	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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Hyperglycemia

Drug Information available for: Insulin Insulin human Insulin, isophane Insulin lispro

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Glycosylated hemoglobin (HbA1c) [ Time Frame: 3 months after transplantation ] [ Designated as safety issue: No ]
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:

Glycosylated hemoglobin (HbA1c) [ Time Frame: 3, 6, 12, 24 months after transplantation ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Fasting glucose and 2h glucose at 6, 12 and 24 months after transplantation.
Beta cell function [ Time Frame: 6, 12, 24 months after transplantation ] [ Designated as safety issue: No ]
Insulinogenic index during an OGTT at 6, 12 and 24 months after kidney transplantation
Insulin sensitivity [ Time Frame: 6, 12, 24 months after transplantation ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: Yes ]
Daily glycemia profile, through evaluation of all available glucose measurements
Serum creatinine [ Time Frame: 6, 12 and 24 months after transplantation ] [ Designated as safety issue: No ]
Serum creatinine at 6, 12 and 24 months after kidney transplantation


Enrollment:	85
Study Start Date:	August 2012
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680185

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


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
Study First Received:	August 30, 2012
Last Updated:	January 27, 2016
Health Authority:	Austria: Agency for Health and Food Safety

Keywords provided by 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 Isophane Insulin, Human Insulin, Isophane Insulin, Short-Acting Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016

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