Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

1. To investigate the effect of insulin glargine (Lantus™) vs NPH insulin regarding glycemic control during the early AM (dawn phenomenon) in individuals with type 1 diabetes.

2. To measure hormones implicated in the pathogenesis of the dawn phenomenon in individuals with type 1 diabetes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc; Insulin, Isophane; Isophane insulin, beef; Isophane Insulin, Human

Criteria

Inclusion Criteria:

• Written informed consent obtained prior to performing screening evaluations.

• Male or female, 18 yrs or older.

• Diagnosis of type 1 diabetes made 5 years prior to screening visit.

• A1C > 6.0% and 9.0% at screening visit.

• Body Mass Index (BMI) 35 kg/m2 at screening visit.

• Documented undetectable C-Peptide

• Ability to follow instructions for Continuous Glucose Monitoring System (CGMS).

• Multiple daily injection participants on at least 3 injections per day. May be treated with NPH or glargine.

Exclusion Criteria:

• Pregnant or lactating females, or females planning to become pregnant during the study or not using an acceptable method of contraception. Females of childbearing potential must have a negative pregnancy test at Visit 3 and Visit 5. Females who become pregnant during the study will be discontinued.

• Type 2 diabetes.

• Two or more severe hypoglycemic episodes (requiring assistance) within six months of Screening.

• Drugs known to affect glycemia (eg. steroids, beta blockers) or conditions that are likely to require steroid therapy or cause metabolic instability in the next 6 months.

• History of allergy or intolerance to NPH or glargine.

• History of hypoglycemia unawareness i.e. no warning symptoms accompanying low (<50 mg/dl) blood glucose levels.

• Unable and/or unlikely to comprehend and/or follow the study protocol (including self blood glucose monitoring, CGMS).

• Currently using an insulin pump.

• Pituitary disorder (Acromegaly, Cushing's, Hypothyroidism etc.) or tumor.

• Two or more severe hypoglycemic episodes (requiring assistance) within six months of Screening.