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

NCT01680185 | Completed Phase 3

• 1 other identifier: SAPT-NODAT_9march2012
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperglycemia

Keywords

Hyperglycemia; NODAT; Insulin pump; Semiclosed loop

Outcome Measures

Primary Outcomes (1)

• Glycosylated hemoglobin (HbA1c)

  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.

  3 months after transplantation

Secondary Outcomes (7)

• Glycosylated hemoglobin (HbA1c)

  3, 6, 12, 24 months after transplantation

• Oral glucose tolerance test (OGTT)-derived 2 hour-glucose

  6, 12, 24 months after transplantation

• Fasting glucose

  6, 12, 24 months after transplantation

• Beta cell function

  6, 12, 24 months after transplantation

• Insulin sensitivity

  6, 12, 24 months after transplantation

Study Arms (3)

Sensor-augmented Insulin Pump

ACTIVE COMPARATOR

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

Basal insulin

ACTIVE COMPARATOR

NPH insulin titration regimen, as specified in the IPT-NODAT study

Drug: Human insulin isophane, Humulin N (Eli Lilly)

Standard of care

ACTIVE COMPARATOR

Patients assigned in this arm will receive standard of care following their kidney transplantation

Other: Standard of care

Interventions

Insulin lispro, Humalog (Eli Lilly) in insulin pump DRUG

all covered above

Sensor-augmented Insulin Pump

Human insulin isophane, Humulin N (Eli Lilly) DRUG

all covered above

Basal insulin

Standard of care OTHER

all covered above

Also known as: Sliding scale short acting insulin for hyperglycemi; Sulphonylurea for NODAT

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.

  PMID: 32803882 DERIVED

MeSH Terms

Conditions

Hyperglycemia

Interventions

Insulin Lispro; Isophane Insulin, Human; Standard of Care; Sulfonylurea Compounds

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Isophane; Insulin, Long-Acting; Insulin, Regular, Human; Insulin; Proinsulin; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Marcus D Säemann, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Marcus Säemann

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 7, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

AU (1)