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Sitagliptin in Cystic Fibrosis-Related Diabetes

Primary Purpose

Cystic Fibrosis

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Sitagliptin
Placebo
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring CFRD, sitagliptin, cystic fibrosis-related diabetes, incretins, hyperglycemia, GIP, GLP-1

Eligibility Criteria

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

Inclusion Criteria:

  • 19 years of age or older
  • Cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy

Exclusion Criteria:

  • Age under 19 years
  • Use of basal insulin therapy
  • Creatinine Clearance < 50 mL/min
  • Active cystic fibrosis exacerbation
  • Pregnancy
  • Women of child-bearing age not using effective contraception
  • Current or prior use of DPPIV inhibitor

Sites / Locations

  • University of British Columbia Gerontology & Diabetes Reserach Centre (ViTALITY)

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 release
The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.

Secondary Outcome Measures

Incretin Response
We will assess incretin release [glucoagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide(GIP)] during the glucose clamp.

Full Information

First Posted
December 2, 2010
Last Updated
March 5, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01257464
Brief Title
Sitagliptin in Cystic Fibrosis-Related Diabetes
Official Title
The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether the dipeptidyl peptidase IV (DPPIV) inhibitor sitagliptin is effective in the treatment of cystic fibrosis-related diabetes (CFRD). We hypothesize that sitagliptin will improve meal-stimulated insulin secretion.
Detailed Description
To date, no clinical trials have been conducted using the DPPIV inhibitor sitagliptin in cystic fibrosis-related diabetes. Cystic fibrosis-related diabetes is characterized initially by post-prandial hyperglycemia, with normal fasting sugars. As the disease progresses, fasting hyperglycemia develops. As sitagliptin augments post-prandial insulin release, while avoiding fasting hypoglycemia, it may be an alternative therapy for cystic fibrosis-related diabetes in individuals who do not yet require basal insulin therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
CFRD, sitagliptin, cystic fibrosis-related diabetes, incretins, hyperglycemia, GIP, GLP-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (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
Other Intervention Name(s)
Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)
Intervention Description
100mg po one dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill po one dose
Primary Outcome Measure Information:
Title
Insulin release
Description
The study protocol is a iv-oral hyperglycemic glucose clamp. We will assess insulin release during the clamp, comparing placebo to sitagliptin.
Time Frame
180 minutes (during clamp)
Secondary Outcome Measure Information:
Title
Incretin Response
Description
We will assess incretin release [glucoagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide(GIP)] during the glucose clamp.
Time Frame
180 minutes (during clamp)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 19 years of age or older Cystic fibrosis-related diabetes with or without fasting hyperglycemia either untreated or using only pre-prandial repaglinide or pre-prandial bolus insulin therapy Exclusion Criteria: Age under 19 years Use of basal insulin therapy Creatinine Clearance < 50 mL/min Active cystic fibrosis exacerbation Pregnancy Women of child-bearing age not using effective contraception Current or prior use of DPPIV inhibitor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graydon Meneilly, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia Gerontology & Diabetes Reserach Centre (ViTALITY)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada

12. IPD Sharing Statement

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Sitagliptin in Cystic Fibrosis-Related Diabetes

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