Glycemic Effects of Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes; Hypoglycemia
Intervention: Evening only administration of insulin glargine (Drug); Morning only administration of insulin glargine (Drug); split dose insulin glargine (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Christopher D Saudek, MD, Principal Investigator, Affiliation: Johns Hopkins University Ari S Eckman, MD, Study Director, Affiliation: Johns Hopkins University
Overall contact: Christopher D Saudek, MD, Phone: 410-955-2132, Email: csaudek@jhu.edu
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 glucose level <70 mg/dL) as measured by continuous glucose monitoring
(CGM) in patients with type 1 diabetes.
Clinical Details
Official title: Comparison of Glycemic Response to Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes Using Continuous Glucose Monitoring
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Time spent (mean number of minutes per 24 hour day) in hypoglycemic range (<70mg/dl)Change in the mean minutes per 24 hour day in the hyperglycemic range of > 180 mg/dL.
Secondary outcome: Time spent in nocturnal hypoglycemic range (midnight to 6am)Time spent in severe hypoglycemic range (<50 mg/dl) Episodes of clinical hypoglycemia (symptoms) Removal from study due to unacceptable hypoglycemia Overall number of hypoglycemic episodes (instances of glucose levels <70 mg/dL) Determine which regimen of glargine insulin preparation best reduces the propensity for nocturnal hypoglycemia Glucose levels at fixed times of day (morning, dinner, bedtime) will be compared
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 the insulin in one regimen, patients will be switched to another
regimen. Through the whole study, patients will be injecting themselves twice daily, and
neither the patient nor the treating doctor will know which vials contain the insulin and
which have only saline (placebo). The vials will be labeled MORNING or EVENING. Patients
will continue to take their mealtime, short acting insulin doses.
Additionally, patients will wear a continuous glucose monitor (CGM) which will be masked.
Before the study, patients will be taught about how to use the CGM, and keep it taped to
their abdomen. The site that the CGM inserts into their abdomen will need to be changed
every 5 days. We will know if a patients' blood sugar goes low even if the patient did not
feel the low. Patients will still have to self-monitor their blood sugar levels at-least
four times in five days, to calibrate the CGM.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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)
Locations and Contacts
Christopher D Saudek, MD, Phone: 410-955-2132, Email: csaudek@jhu.edu
Johns Hopkins Hospital, Baltimore, Maryland 21287, United States
Additional Information
Related publications: Garg SK, Gottlieb PA, Hisatomi ME, D'Souza A, Walker AJ, Izuora KE, Chase HP. Improved glycemic control without an increase in severe hypoglycemic episodes in intensively treated patients with type 1 diabetes receiving morning, evening, or split dose insulin glargine. Diabetes Res Clin Pract. 2004 Oct;66(1):49-56. Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart. Diabet Med. 2006 Aug;23(8):879-86.
Starting date: March 2009
Last updated: March 25, 2009
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