Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon (NCT00694122) | Clinical Trial Compass
CompletedPhase 3
Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon
United States27 participantsStarted 2005-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 (Acromeg…