Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon
Completed · Phase 3
Conditions studied: Type 1 Diabetes, Dawn Phenomenon
In brief
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.
Key facts
- Study ID
- NCT00694122
- Run by
- Massachusetts General Hospital
- People needed
- 27
- Starts
- 2005-06-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2014-10-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Massachusettes General Hospital/ Diabetes Research Center — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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