Abstract: TH-PO1161
Insulin Therapy for the Prevention of Posttransplantation Diabetes Mellitus: Preliminary Results from an International Multicenter Study (ITP-NODAT)
Session Information
- Late-Breaking Clinical Trials Posters
October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Transplantation
- No subcategory defined
Authors
- Schwaiger, Elisabeth, Medical University Vienna, Vienna, Austria
- Bergfeld, Leon, Charité Universitätsmedizin Berlin, Berlin, Germany
- Budde, Klemens, Charite Universitatsmedizin Berlin, Berlin, Germany
- Pascual, Julio, Hospital del Mar, Parc de Salut Mar, Barcelona, Spain
- Eller, Kathrin, Graz Medical University, Graz, Austria
- Rosenkranz, Alexander R., Medizinische Universität Graz, Graz, ST, Austria
- Saemann, Marcus D., Wilhelminen Hospital, Vienna, Austria
- Hecking, Manfred, Medical University of Vienna, Nephrology & Dialysis, Vienna, Austria
Background
In our previous proof-of-concept trial, basal insulin therapy early after kidney transplantation significantly reduced the odds of posttransplantation diabetes mellitus (PTDM) throughout 1 year of follow-up (PMID22343119). The ITP-NODAT study aimed at reproducing these findings (NCT03507829).
Methods
Kidney transplant recipients without diabetes history were randomized to receive immediate insulin isophane treatment for pre-dinner glucose ≥140 mg/dL, or short-acting insulin and/or oral antidiabetics for fasting glucose ≥200 mg/dL. Primary endpoint: PTDM incidence at 12 months.
Results
Of 263 patients enrolled at 4 centers, N=205 completed month 24 by 5/2018. 119 of 133 treatment patients received insulin for a median duration of 49 days while 18 of 130 control patients received insulin and/or oral antidiabetics for a median duration of 730 days (Figure: A/B). We observed 17 versus 1 episodes of hypoglycemia in treatment versus control patients (none clinically concerning). While results from oral glucose tolerance tests are currently being evaluated, fasting glucose and HbA1c data indicate that treatment and control patients did not separate well in terms of glycemic control (Figure: C/D). Based on HbA1c (≥6.5 %) and antidiabetic treatment, 13 patients in each group classified as diabetics at 12 months.
Conclusion
(1) Exogenous insulin therapy was relatively safe; (2) treatment and control patients had a similarly low PTDM incidence and a low rise in HbA1c over follow-up; (3) there were more control group than treatment group patients who required prolonged antidiabetic therapy. Result (2) differs from our previous trial, where PTDM incidence had been higher, and significantly different between groups. The lower glucocorticoid regimen in ITP-NODAT and increased PTDM awareness likely contributed to this difference.
Funding
- NIDDK Support – Astellas Pharma, Eli Lilly