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

NCT ID: NCT00869414

Last Updated: 2017-06-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-03-31

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.

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.

Conditions

Type 1 Diabetes; Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

insulin glargine only in morning

Morning only administration of insulin glargine

Group Type: ACTIVE_COMPARATOR

Morning only administration of insulin glargine

Intervention Type: DRUG

Morning only administration of insulin glargine, with normal saline injection administered at night.

insulin glargine only at evening

Evening only administration of insulin glargine

Group Type: ACTIVE_COMPARATOR

Evening only administration of insulin glargine

Intervention Type: DRUG

Evening only administration of insulin glargine, with normal saline injection administered in the morning.

split dose insulin glargine

Split dose administration of insulin glargine, half dose in morning, half dose in evening

Group Type: ACTIVE_COMPARATOR

split dose insulin glargine

Intervention Type: DRUG

split dose of insulin glargine, half administered in the morning, half administered in evening

Interventions

Evening only administration of insulin glargine

Evening only administration of insulin glargine, with normal saline injection administered in the morning.

Intervention Type: DRUG

Morning only administration of insulin glargine

Morning only administration of insulin glargine, with normal saline injection administered at night.

Intervention Type: DRUG

split dose insulin glargine

split dose of insulin glargine, half administered in the morning, half administered in evening

Intervention Type: DRUG

Other Intervention Names

Lantus; Lantus; Lantus

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher D Saudek, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Ari S Eckman, MD

Role: STUDY_DIRECTOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15364161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16911626 (View on PubMed)

Other Identifiers

NA_00024168

Identifier Type: -

Identifier Source: org_study_id