Phase 4 N=83 Randomized Triple-blind Treatment

Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

Pancreatitis · Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01186562 ↗

Enrolled (actual)

Serious AEs

68.7%

Results posted

Dec 2016

Primary outcome: Primary: Insulin Independence — 42; 45 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sitagliptin (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Jul 2015

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	—
SECONDARY Acute C-peptide Response (ACR) to Glucose	6.9; 6.0	—

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.

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01186562). 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.