Overview

Insulin Glargine Vs Standard Insulin Therapy

Status:
Completed

Trial end date:
2005-08-01

Target enrollment:
0

Participant gender:
All

Summary

This Study is designed to determine whether treatment of CFRD with glargine insulin will improve hemoglobin A1c, weight and muscle mass compared to the traditional regimen of bedtime NPH insulin.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Minnesota
University of Minnesota - Clinical and Translational Science Institute

Collaborators:

Moran, Antoinette, M.D.
Sanofi

Treatments:

Insulin
Insulin Glargine
Insulin, Globin Zinc

Criteria

1. Inclusion Criteria

1. CFRD with fasting hyperglycemia (fasting plasma glucose ≥126 mg/dl)

1. . The diagnosis must be made at a time when the patient is in his/her basal
state of health with no evidence of acute exacerbation in the preceding two
months.

a). Acute exacerbation is defined on page 9.

2. . For patients with onset of diabetes in the preceding 6 months, the
hemoglobin A1c must be stable for 3 months prior to study entrance within 5%
(0.3% A1c increment).

2. Age ≥18, post-pubertal (done growing, since change in weight is a study endpoint)

3. Weight stable within 5% during the previous 3 months as measured in CF clinic

4. Willingness to attend all study visits and to engage in regular phone or e-mail
contact with the study diabetes nurse

5. Glucocorticoids can have a profound effect on weight, and thus we wish to
minimize the occurrence of changing steroid doses during the study period.
Patients receiving glucocorticoid therapy will be included in the protocol only
if:

1. . They have been on the same steroid dose for the preceding six months,

2. . There are no plans to change their steroid dose in the next eight months.

2. Exclusion Criteria

1. Pregnancy or plans to become pregnant in the next eight months (because of the
changes pregnancy would cause in our study endpoints),

2. Unwillingness / inability to take multiple injections or to count carbohydrates,

3. A history of hypoglycemia unawareness (rare in CF),

4. Plans to start any medication in the next 8 months that might affect weight, such
as testosterone or Megace. Patients chronically taking these medications may be
included if:

1. . They have been on the same dose for the preceding six months

2. . There are no plans to change their dose in the next eight months