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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00869414
• Other study ID #: NA_00024168
• Status: Not yet recruiting
• Phase: N/A
• First received: March 25, 2009
• Last updated: March 25, 2009
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: March 2009
• Source: Johns Hopkins University
• Contact: Christopher D Saudek, MD
• Phone: 410-955-2132
• Email: csaudek[@]jhu.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Drug:
• Evening only administration of insulin glargine
Evening only administration of insulin glargine, with normal saline injection administered in the morning.
• Morning only administration of insulin glargine
Morning only administration of insulin glargine, with normal saline injection administered at night.
• split dose insulin glargine
split dose of insulin glargine, half administered in the morning, half administered in evening

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time spent (mean number of minutes per 24 hour day) in hypoglycemic range (<70mg/dl)		6 weeks	Yes
Primary	Change in the mean minutes per 24 hour day in the hyperglycemic range of > 180 mg/dL.		6 weeks	Yes
Secondary	Time spent in nocturnal hypoglycemic range (midnight to 6am)		6 weeks	Yes
Secondary	Time spent in severe hypoglycemic range (<50 mg/dl)		6 weeks	Yes
Secondary	Episodes of clinical hypoglycemia (symptoms)		6 weeks	Yes
Secondary	Removal from study due to unacceptable hypoglycemia		6 weeks	Yes
Secondary	Overall number of hypoglycemic episodes (instances of glucose levels <70 mg/dL)		6 weeks	Yes
Secondary	Determine which regimen of glargine insulin preparation best reduces the propensity for nocturnal hypoglycemia		6 weeks	Yes
Secondary	Glucose levels at fixed times of day (morning, dinner, bedtime) will be compared		6 weeks	Yes