Phase 4
Completed N=83
Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant
Source: ClinicalTrials.gov NCT01186562 ↗Enrolled (actual)
83
Serious AEs
68.7%
Results posted
Dec 2016
Primary outcomePrimary: Insulin Independence — 42; 45 percentage of participants
◆ Published Evidence
Established
24citations · ~3 / year
Sitagliptin Treatment After Total Pancreatectomy With Islet Autotransplantation: A Randomized, Placebo-Controlled Study.
Summary
The purpose of the study is to test the effects of sitagliptin on the need for insulin (the hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet autotransplant for chronic pancreatitis.
Linked Publications (2)
-
Sitagliptin Treatment After Total Pancreatectomy With Islet Autotransplantation: A Randomized, Placebo-Controlled Study.
-
Body Composition is Associated With Islet Function After Pancreatectomy and Islet Autotransplantation for Pancreatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insulin Independence |
36; 44 | — |
| SECONDARY Insulin Independence |
36; 44 | — |
| SECONDARY Area Under the Curve (AUC) C-peptide (ng/dL*Min) |
273; 273 | — |
| SECONDARY AUC C-peptide |
274; 235 | — |
| SECONDARY Acute C-peptide Response (ACR) to Glucose |
6.9; 6.0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years
- Scheduled for total pancreatectomy and IAT at UM
Exclusion Criteria
- Pre-existing diabetes mellitus or hyperglycemia with fasting glucose ≥115 mg/dl
- Medical conditions which, in the opinion of the investigator, might impact islet function (e.g asthma or inflammatory disease requiring chronic systemic corticosteroids)
- Significant renal disease: serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women, or end-stage renal disease requiring hemodialysis or peritoneal dialysis.
- For female subjects, plans to become pregnant or unwillingness to practice birth control for 18 months.
- Islet yield <1, 000 IE/kg body weight (exclusion for treatment with drug/placebo)
Data sourced from ClinicalTrials.gov (NCT01186562) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.