NCT00072904

Brief Summary

To recruit 150 adult patients with cystic fibrosis related diabetes (CFRD) without fasting hyperglycemia for a multi-center, twelve month, placebo-controlled intervention trial testing the ability of insulin or repaglinide to improve body mass index (BMI) and stabilize pulmonary function in cystic fibrosis (CF).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_3

Geographic Reach
2 countries

7 active sites

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

June 1, 2001

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

6.5 years

First QC Date

November 12, 2003

Last Update Submit

February 27, 2012

Conditions

Cystic FibrosisDiabetes Mellitus

Keywords

Cystic Fibrosis Related DiabetesDiabetes without Fasting Hyperglycemia

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this research is to determine whether treatment with either insulin or an oral diabetes agent that increases endogenous insulin secretion will improve BMI and pulmonary function in cystic fibrosis patients who have diabetes

    12 months

Study Arms (1)

III

PLACEBO COMPARATOR

Placebo take half tab with meals tid

Drug: Insulin AsparteDrug: Repaglinide

Interventions

Insulin AsparteDRUG

Insulin asparte given 0.5 units per carb per meal

III
RepaglinideDRUG

0.5mg tab with meals tid

III

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* Diabetic glucose pattern by oral glucose tolerance test (OGTT) of \>200 at 120 min. (stable and healthy at time of OGTT) * Fasting glucose levels \<126. * Weight stable within 5% in previous 3 months. * Free from illness for two months. * Male and female 16 and older, who are done growing * Willing to come in for visits every 3 months. * Patients receiving infrequent short bursts of systemic glucocorticoids may be considered for the study inclusion if: a. they have not received systemic glucocorticoids steroids for at least one month, b. they did not receive the steroids for more than 14 consecutive days or 28 days total in six months

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Stanford University

Palo Alto, California, 94304, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213-2583, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2650, United States

Location

University of Utah

Salt Lake City, Utah, 84132-4701, United States

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

  • Moran A, Pekow P, Grover P, Zorn M, Slovis B, Pilewski J, Tullis E, Liou TG, Allen H; Cystic Fibrosis Related Diabetes Therapy Study Group. Insulin therapy to improve BMI in cystic fibrosis-related diabetes without fasting hyperglycemia: results of the cystic fibrosis related diabetes therapy trial. Diabetes Care. 2009 Oct;32(10):1783-8. doi: 10.2337/dc09-0585. Epub 2009 Jul 10.

    PMID: 19592632RESULT

MeSH Terms

Conditions

Cystic FibrosisDiabetes Mellitus

Interventions

repaglinide

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 DiseasesEndocrine System Diseases

Study Officials

  • Antoinette Moran, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 12, 2003

First Posted

November 14, 2003

Study Start

June 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

US(6)CA(1)