title: Sitagliptin Treatment After Total Pancreatectomy With Islet Autotransplantation: A Randomized, Placebo-Controlled Study.
abstract: Insulin independence after total pancreatectomy and islet autotransplant (TPIAT) for chronic pancreatitis is limited by a high rate of postprocedure beta cell apoptosis. Endogenous glucagon-like peptide-1 and glucose-dependent insulinotropic peptide, which are increased by dipeptidyl peptidase 4 inhibitor therapy (sitagliptin) may protect against beta cell apoptosis. To determine the effect of sitagliptin after TPIAT, 83 adult TPIAT recipients were randomized to receive sitagliptin (n = 54) or placebo (n = 29) for 12 months after TPIAT. At 12 and 18 months after TPIAT, participants were assessed for insulin independence; metabolic testing was performed with mixed meal tolerance testing and frequent sample intravenous glucose tolerance testing. Insulin independence did not differ between the sitagliptin and placebo groups at 12 months (42% vs. 45%, p = 0.82) or 18 months (36% vs. 44%, p = 0.48). At 12 months, insulin dose was 9.0 (standard error 1.7) units/day and 7.9 (2.2) units/day in the sitagliptin and placebo groups, respectively (p = 0.67) and at 18 months 10.3 (1.9) and 7.1 (2.6) units/day, respectively (p = 0.32). Hemoglobin A1clevels and insulin secretory measures were similar in the two groups, as were adverse events. In conclusion, sitagliptin could be safely administered but did not improve metabolic outcomes after TPIAT.
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: M D
authors.initials: MD
authors.lastname: Bellin
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: G J
authors.initials: GJ
authors.lastname: Beilman
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: T B
authors.identifier: 0000-0002-5941-0659
authors.initials: TB
authors.lastname: Dunn
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: T L
authors.initials: TL
authors.lastname: Pruett
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: D E R
authors.initials: DE
authors.lastname: Sutherland
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: S
authors.initials: S
authors.lastname: Chinnakotla
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: J S
authors.initials: JS
authors.lastname: Hodges
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: A
authors.initials: A
authors.lastname: Lane
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: P
authors.initials: P
authors.lastname: Ptacek
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: K L
authors.initials: KL
authors.lastname: Berry
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: B J
authors.initials: BJ
authors.lastname: Hering
authors.affiliation: Departments of Pediatrics, Surgery, Biostatistics, Schulze Diabetes Institute, University of Minnesota, Minneapolis, MN.
authors.forename: A
authors.initials: A
authors.lastname: Moran
mesh_terms: D000328:Adult; D001786:Blood Glucose; D003920:Diabetes Mellitus / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin; D006084:Graft Rejection / Q000188:drug therapy* / Q000209:etiology; D006085:Graft Survival / Q000187:drug effects*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D050417:Insulin-Secreting Cells / Q000473:pathology*; D016381:Islets of Langerhans Transplantation / Q000009:adverse effects*; D008297:Male; D010180:Pancreatectomy / Q000009:adverse effects*; D000068900:Sitagliptin Phosphate / Q000627:therapeutic use*; D014182:Transplantation, Autologous
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000068900:Sitagliptin Phosphate
keywords: clinical research/practice; clinical trial; diabetes; graft survival; insulin/C-peptide; islet transplantation; islets of Langerhans