Status:
COMPLETED
Insulin Glargine Vs Standard Insulin Therapy
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Sanofi
Moran, Antoinette, M.D.
Conditions:
Cystic Fibrosis Related Diabetes
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief 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.
Detailed Description
The majority of cystic fibrosis (CF) patients now survive beyond childhood, and CF related diabetes (CFRD), due to insulin deficiency, is common. CFRD with fasting hyperglycemia occurs in about 15% of...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- CFRD with fasting hyperglycemia (fasting plasma glucose ≥126 mg/dl)
- . 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.
- . 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).
- Age ≥18, post-pubertal (done growing, since change in weight is a study endpoint)
- Weight stable within 5% during the previous 3 months as measured in CF clinic
- Willingness to attend all study visits and to engage in regular phone or e-mail contact with the study diabetes nurse
- 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:
- . They have been on the same steroid dose for the preceding six months,
- . There are no plans to change their steroid dose in the next eight months.
- Exclusion Criteria
- Pregnancy or plans to become pregnant in the next eight months (because of the changes pregnancy would cause in our study endpoints),
- Unwillingness / inability to take multiple injections or to count carbohydrates,
- A history of hypoglycemia unawareness (rare in CF),
- 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:
- . They have been on the same dose for the preceding six months
- . There are no plans to change their dose in the next eight months
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00222521
Start Date
April 1 2003
End Date
August 1 2005
Last Update
September 22 2005
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455