NCT01257464

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.

Trial Health

57
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Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
terminated

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

September 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

December 2, 2010

Last Update Submit

March 5, 2014

Conditions

Cystic Fibrosis

Keywords

CFRDsitagliptincystic fibrosis-related diabetesincretinshyperglycemiaGIPGLP-1

Outcome Measures

Primary Outcomes (1)

  • Insulin release

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

    180 minutes (during clamp)

Secondary Outcomes (1)

  • Incretin Response

    180 minutes (during clamp)

Study Arms (2)

Sitagliptin

ACTIVE COMPARATOR
Drug: Sitagliptin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SitagliptinDRUG

100mg po one dose

Also known as: Januvia, MK-0431, Dipeptidyl peptidase IV inhibitor (DPP-4 inhibitor)
Sitagliptin
PlaceboDRUG

Sugar pill po one dose

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vancouver, British Columbia, V5Z 1L8, Canada

Location

MeSH Terms

Conditions

Cystic FibrosisHyperglycemia

Interventions

Sitagliptin PhosphateDipeptidyl-Peptidase IV Inhibitors

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesProtease InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • Graydon Meneilly, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 9, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

CA(1)