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Study Name: Effect of Insulin or Repaglinide on Body Weight and Pulmonary Function in Patients with CF Related Diabetes
Study Type: Interventional
Intervention Category: Other
Study Sponsor: Moran, Antoinette
Study Phase: 3
Recruitment Status: Trial Completed
Study Drug(s): Repaglinide
Number of Participants Being Recruited: 108
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study will examine the specific effects of insulin in CF patients with diabetes. More than 1 in 4 people with CF have cystic fibrosis related diabetes â?? a kind of diabetes that differs from traditional diabetes. It is believed that CF patients with this kind of diabetes experience a more rapid loss of healthy weight and deterioration in pulmonary function when compared to other CF patients.

The primary objective of this study is to determine whether treatment with either insulin (or a medication that increases insulin levels) will improve healthy body weight and pulmonary function in cystic fibrosis patients who have CF-related diabetes. Healthy body weight will be measured by determining a patientâ??s body mass index or BMI (a measure of body weight relative to height).
ELIGIBILITY
Age: >= 16 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Moran, Antoinette
(612) 624-5409
moran001@umn.edu
Trial Specific Link on ClinicalTrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00072904?term=diabetes+and+cystic+fibrosis&rank=1
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

A three-arm multicenter randomized trial compared 1 year of therapy with premeal insulin aspart, repaglinide, or oral placebo in subjects with cystic fibrosis who had abnormal glucose tolerance. One hundred adult patients were enrolled. Eighty-one completed the study, including 61 with CFRD FH- and 20 with severly impaired glucose tolerance (IGT). During the year before therapy, BMI declined in all groups. Among the group with CFRD FH-, insulin-treated patients lost 0.30 ± 0.21 BMI units the year before therapy. After 1 year of insulin therapy, this pattern reversed, and they gained 0.39 ± 21 BMI units (P = 0.02). No significant change in the rate of BMI decline was seen in placebo-treated patients (P = 0.45). Repaglinide-treated patients had an initial significant BMI gain, but this effect was not sustained. At the end of the study (12 months) there was no difference in the rate of BMI change during the study year compared with the year before (P = 0.33). Among patients with IGT, neither insulin nor repaglinide affected the rate of BMI decline.

Secondary Efficacy:

No differences were seen in the rate of lung function decline or the number of hospitalizations in any group.

Safety:

In the first 3 months, significantly more patients receiving active medication compared with those receiving placebo reported mild hypoglycemic events. In most cases these resolved with patient education. After the first 3 months, there were no significant differences between groups in the frequency of hypoglycemia

Citation:

Diabetes Care 2009;32(10):1783-1788

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