Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes

Stopped early · Not applicable

Conditions studied: Type 1 Diabetes, Hypoglycemia

In brief

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 glucose level \<70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.

Key facts

Study ID

NCT00869414

Run by

Johns Hopkins University

People needed

16

Starts

2009-07-01

Expected to finish

2010-03-01

Last updated by the study team

2017-06-29

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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)

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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