Diabetes Therapy to Improve BMI and Lung Function in CF

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2007-12-31

Brief Summary

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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).

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Detailed Description

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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 without fasting hyperglycemia.

Conditions

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Cystic Fibrosis Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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III

Placebo take half tab with meals tid

Group Type PLACEBO_COMPARATOR

Insulin Asparte

Intervention Type DRUG

Insulin asparte given 0.5 units per carb per meal

Repaglinide

Intervention Type DRUG

0.5mg tab with meals tid

Interventions

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Insulin Asparte

Insulin asparte given 0.5 units per carb per meal

Intervention Type DRUG

Repaglinide

0.5mg tab with meals tid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes