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

NCT00869414 | Terminated Results DMC

• 1 other identifier: NA_00024168
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl)

  6 weeks

• Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL.

  6 weeks

Study Arms (3)

insulin glargine only in morning

ACTIVE COMPARATOR

Morning only administration of insulin glargine

Drug: Morning only administration of insulin glargine

insulin glargine only at evening

ACTIVE COMPARATOR

Evening only administration of insulin glargine

Drug: Evening only administration of insulin glargine

split dose insulin glargine

ACTIVE COMPARATOR

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

Drug: split dose insulin glargine

Interventions

Evening only administration of insulin glargine DRUG

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

Also known as: Lantus

insulin glargine only at evening

Morning only administration of insulin glargine DRUG

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

Also known as: Lantus

insulin glargine only in morning

split dose insulin glargine DRUG

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

Also known as: Lantus

split dose insulin glargine

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

• 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.

  PMID: 15364161 BACKGROUND

• 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.

  PMID: 16911626 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Johns Hopkins University Clinical Trials Program
• Organization: Johns Hopkins University School of Medicine

registerclinicaltrials@jhmi.edu

410-550-6484

Study Officials

• Christopher D Saudek, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Ari S Eckman, MD

  Johns Hopkins University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 26, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 29, 2017
• Results First Posted: June 29, 2017

Record last verified: 2017-05

Locations

US (1)