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

• ClinicalTrials.gov Identifier: NCT00869414
• Recruitment Status: Terminated
• First Posted: March 26, 2009
• Results First Posted: June 29, 2017
• Last Update Posted: June 29, 2017
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes; Hypoglycemia	Drug: Evening only administration of insulin glargine; Drug: Morning only administration of insulin glargine; Drug: split dose insulin glargine	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 2009
• Actual Primary Completion Date: March 2010
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: insulin glargine only in morning; Morning only administration of insulin glargine	Drug: Morning only administration of insulin glargine; Morning only administration of insulin glargine, with normal saline injection administered at night.; Other Name: Lantus
Active Comparator: insulin glargine only at evening; Evening only administration of insulin glargine	Drug: Evening only administration of insulin glargine; Evening only administration of insulin glargine, with normal saline injection administered in the morning.; Other Name: Lantus
Active Comparator: split dose insulin glargine; Split dose administration of insulin glargine, half dose in morning, half dose in evening	Drug: split dose insulin glargine; split dose of insulin glargine, half administered in the morning, half administered in evening; Other Name: Lantus

Outcome Measures

Primary Outcome Measures :

1. Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl) [ Time Frame: 6 weeks ]
2. Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL. [ Time Frame: 6 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Principal Investigator: Christopher D Saudek, MD; Johns Hopkins University
• Study Director: Ari S Eckman, MD; Johns Hopkins University

More Information

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. doi: 10.1016/j.diabres.2004.02.008.

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. doi: 10.1111/j.1464-5491.2006.01913.x.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00869414
• Other Study ID Numbers: NA_00024168
• First Posted: March 26, 2009
• Results First Posted: June 29, 2017
• Last Update Posted: June 29, 2017
• Last Verified: May 2017

Keywords provided by Johns Hopkins University:

hypoglycemia; type 1 diabetes; split dosing insulin glargine; continuous glucose monitoring

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Insulin; Insulin, Globin Zinc; Insulin Glargine; Hypoglycemic Agents; Physiological Effects of Drugs