Status:
TERMINATED
Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes
Lead Sponsor:
Johns Hopkins University
Conditions:
Type 1 Diabetes
Hypoglycemia
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood gl...
Detailed Description
Over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night. After 2 weeks taking ...
Eligibility Criteria
Inclusion
- Adult men and women above age 18 with a diagnosis of type 1 diabetes mellitus
- On multiple insulin injections, including a long acting or intermediate acting insulin preparation and mealtime short acting insulin preparation.
- Clinical history consistent with hypoglycemia
- Hba1c \<9.0%
Exclusion
- Patients with type 2 diabetes mellitus
- Patients on insulin pump
- Poor control of diabetes (HbA1c \> 9.0%)
- Pregnancy (women of childbearing age will undergo a pregnancy test at the start of the study and will be advised to use birth control methods during the study). Insulin glargine has been reported to have teratogenic effects in animal models, and therefore should only be used during pregnancy if clearly needed.
- Serious co-morbidities that, in clinical opinion of the investigators, could affect pharmacokinetics of glargine (e.g., CRF) or safety (e.g., recent CAD)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00869414
Start Date
July 1 2009
End Date
March 1 2010
Last Update
June 29 2017
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287