Insulin Glargine Vs Standard Insulin Therapy

NCT00222521 | Completed Phase 3

• 1 other identifier: 0205M25461
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis Related Diabetes

Keywords

Cystic Fibrosis; Diabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

Secondary Outcomes (4)

• BMI

• Body composition by DEXA Scan

• # Episodes of illness

• Quality of life survey

Interventions

Glargine insulin DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Sanofi: collaborator
• Moran, Antoinette, M.D.: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Antoinette Moran, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 22, 2005
• Study Start: April 1, 2003
• Study Completion: August 1, 2005
• Last Updated: September 22, 2005

Record last verified: 2005-09

Locations

US (1)