Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon (DAWN)
Type 1 Diabetes, Dawn Phenomenon
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring glucose, cortisol, growth hormone, glucagon, insulin
Eligibility 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.
Sites / Locations
- Massachusettes General Hospital/ Diabetes Research Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Glargine (Lantus) insulin
NPH insulin
Long acting insulin, glargine, that subject currently used as an outpatient. SC injections. Dose given at 22:00 is based on past week blood glucose data during evening overnight hours and AM glucose. 20.2 +/- 11.7 units glargine (mean +/- SD). Glargine (Lantus): Sanolfi Aventis Hourly blood glucose from 22:00 to 08:00 while receiving glargine (Lantus) insulin will be compared with the NPH insulin arm.
Long acting insulin, NPH, that participant was currently while an outpatient. SC injections. Dose (units) given at 22:00 is based on past week blood glucose during evening overnight period and AM glucose. 20.7 +/- 10.0 units NPH (mean +/- SD). NPH: Eli Lilly Hourly blood glucose from 22:00 to 08:00 while receiving glargine (Lantus) insulin will be compared with the glargine (Lantus) insulin arm.