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Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

Primary Purpose

Pancreatitis, Diabetes

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sitagliptin

Placebo

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring Pancreatitis, Pancreatectomy, Islet autotransplant, Sitagliptin, Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sitagliptin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Insulin Independence

percentage of patients insulin independent

Secondary Outcome Measures

Insulin Independence

percentage of patients insulin independent

Area Under the Curve (AUC) C-peptide (ng/dL*Min)

AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)

AUC C-peptide

AUC C-peptide (ng/dL*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)

Acute C-peptide Response (ACR) to Glucose

Derived from intravenous gluocose tolerance testing (0 to 10 minute measures after dextrose bolus)

Acute C-peptide Response (ACR) to Glucose

Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)

Full Information

NCT ID

NCT01186562

First Posted

August 4, 2010

Last Updated

May 2, 2017

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT01186562

Brief Title

Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

Official Title

A Double-Blind, Randomized, Placebo Controlled Intervention Study to Assess the Impact of Sitagliptin 100 mg/Day for 1 Year on Insulin Independence Following Pancreatectomy and Autoislet Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

At the current time, about one-third of patients are insulin independent (do not need to take insulin) after autotransplant, but the other two-thirds still need some insulin. Sitagliptin works by increasing the amount of a hormone called glucagon-like peptide 1, or GLP-1, in the body which then increases the amount of insulin that is made by the beta cells(the insulin producing cell of the islets). GLP-1 might also help protect beta cells from dying under stressful conditions and increase the production of new beta cells. The primary goal of this study is to see if taking sitagliptin for one year after islet autotransplant increases the number of patients who achieve and maintain insulin independence. Other goals of this study are to see if sitagliptin reduces the amount of insulin injections needed or helps the islets make more insulin.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatitis, Diabetes

Keywords

Pancreatitis, Pancreatectomy, Islet autotransplant, Sitagliptin, Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

83 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sitagliptin

Arm Type

Active Comparator

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Sitagliptin

Intervention Description

100 mg PO daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

Insulin Independence

Description

percentage of patients insulin independent

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Insulin Independence

Description

percentage of patients insulin independent

Time Frame

18 months

Title

Area Under the Curve (AUC) C-peptide (ng/dL*Min)

Description

AUC C-peptide obtained from a mixed meal test (measured time 0 to 2 hours after Boost HP)

Time Frame

12 months

Title

AUC C-peptide

Description

AUC C-peptide (ng/dL*min) from mixed meal tolerance test (measured times 0 to 2 hours after Boost HP)

Time Frame

18 months

Title

Acute C-peptide Response (ACR) to Glucose

Description

Derived from intravenous gluocose tolerance testing (0 to 10 minute measures after dextrose bolus)

Time Frame

12 months

Title

Acute C-peptide Response (ACR) to Glucose

Description

Derived from intravenous glucose tolerance test (0 to 10 minute measures after IV dextrose bolus)

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Melena Bellin, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33124670

Citation

Harindhanavudhi T, Yang Y, Hodges JS, Pruett TL, Kirchner V, Beilman GJ, Bellin MD. Body Composition is Associated With Islet Function After Pancreatectomy and Islet Autotransplantation for Pancreatitis. J Clin Endocrinol Metab. 2021 Jan 23;106(2):e496-e506. doi: 10.1210/clinem/dgaa790.

Results Reference

derived

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Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

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