NCT01186562

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 4, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
7 months until next milestone

Results Posted

Study results publicly available

December 28, 2016

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

4.9 years

First QC Date

August 4, 2010

Results QC Date

October 28, 2016

Last Update Submit

May 2, 2017

Conditions

PancreatitisDiabetes

Keywords

PancreatitisPancreatectomyIslet autotransplantSitagliptinDiabetes

Outcome Measures

Primary Outcomes (1)

  • Insulin Independence

    percentage of patients insulin independent

    12 months

Secondary Outcomes (5)

  • Insulin Independence

    18 months

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

    12 months

  • AUC C-peptide

    18 months

  • Acute C-peptide Response (ACR) to Glucose

    12 months

  • Acute C-peptide Response (ACR) to Glucose

    18 months

Study Arms (2)

Sitagliptin

ACTIVE COMPARATOR
Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SitagliptinDRUG

100 mg PO daily

Sitagliptin
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Scheduled for total pancreatectomy and IAT at UM

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

  • 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.

    PMID: 33124670DERIVED

MeSH Terms

Conditions

PancreatitisDiabetes Mellitus

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Limitations and Caveats

It is also possible that the study is not powered enough to detect small differences in insulin independence. The feasibility of conducting any larger trial in the small population of adult islet autograft recipients is limited, however.

Results Point of Contact

Title
Melena D. Bellin
Organization
University of Minnesota
bell0130@umn.edu
612-624-5409

Study Officials

  • Melena Bellin, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2010

First Posted

August 23, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2015

Study Completion

June 1, 2016

Last Updated

May 31, 2017

Results First Posted

December 28, 2016

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)