Status:
COMPLETED
Comparison of Lantus and Neutral Protamine Hagedorn (NPH) Insulin in the Dawn Phenomenon
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Sanofi
Conditions:
Type 1 Diabetes
Dawn Phenomenon
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 i...
Detailed Description
Title: COMPARISON of LANTUS and NPH INSULIN IN THE DAWN PHENOMENON I. Background and Significance Diabetes mellitus affects greater than 6% of the population, with type 2 more prevalent than type 1....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00694122
Start Date
June 1 2005
End Date
November 1 2010
Last Update
October 21 2014
Active Locations (1)
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1
Massachusettes General Hospital/ Diabetes Research Center
Boston, Massachusetts, United States, 02114