NCT00222521

Insulin Glargine Vs Standard Insulin Therapy

Comparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting Hyperglycemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 adult CF patients. Standard insulin therapy has relied primarily on meal coverage with rapid-acting insulin. Usually, basal insulin coverage is only provided overnight, with modest doses of NPH insulin. The practice of providing minimal basal insulin in CFRD is based on the fact that most of these patients, unless they are acutely ill, are able to maintain relatively normal blood glucose levels during the day without it. In addition, anecdotal experience has suggested that daytime NPH insulin or once to twice daily ultralente insulin frequently lead to hypoglycemia in the CFRD patient. This practice, which is based on practical clinical considerations, ignores the established relationship between insulin deficiency and clinical deterioration in CFRD. BMI and pulmonary function deteriorate much more rapidly in CF patients with diabetes than in CF patients with normal glucose tolerance. Insulin deficiency leads to increased protein catabolism and fatty acid turnover. The resulting loss of weight and lean body mass contributes to pulmonary disease and clinical decline. We hypothesize that: 1. Basal insulin coverage with insulin glargine will improve hemoglobin A1c, weight, and muscle mass in patients with CFRD with fasting hyperglycemia, compared to traditional regimens with less basal insulin. 2. Because of the peakless action of insulin glargine, this will be accomplished without serious hypoglycemia.

Conditions

• Cystic Fibrosis Related Diabetes

Interventions

Type	Name	Description
DRUG	Glargine insulin

Timeline

• Start date: 2003-04-01
• Completion: 2005-08-01
• First posted: 2005-09-22
• Last updated: 2005-09-22

Locations

1 site across 1 country: United States