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

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00869414

Purpose

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	Intervention
Type 1 Diabetes Hypoglycemia	Drug: Evening only administration of insulin glargine Drug: Morning only administration of insulin glargine Drug: split dose insulin glargine

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Crossover Assignment
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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Time spent (mean number of minutes per 24 hour day) in hypoglycemic range (<70mg/dl) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Change in the mean minutes per 24 hour day in the hyperglycemic range of > 180 mg/dL. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time spent in nocturnal hypoglycemic range (midnight to 6am) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Time spent in severe hypoglycemic range (<50 mg/dl) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Episodes of clinical hypoglycemia (symptoms) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Removal from study due to unacceptable hypoglycemia [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Overall number of hypoglycemic episodes (instances of glucose levels <70 mg/dL) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Determine which regimen of glargine insulin preparation best reduces the propensity for nocturnal hypoglycemia [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Glucose levels at fixed times of day (morning, dinner, bedtime) will be compared [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	25
Study Start Date:	March 2009
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
insulin glargine only in morning: Active Comparator 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.
insulin glargine only at evening: Active Comparator 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.
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 split dose of insulin glargine, half administered in the morning, half administered in evening

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869414

Contacts

Contact: Christopher D Saudek, MD	410-955-2132	csaudek@jhu.edu
Contact: Ari S Eckman, MD	410-614-4114	aeckman1@jhmi.edu

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.

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.

Responsible Party:	Johns Hopkins Hospital ( Christopher D. Saudek )
Study ID Numbers:	NA_00024168
Study First Received:	March 25, 2009
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00869414 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

hypoglycemia
type 1 diabetes
split dosing insulin glargine
continuous glucose monitoring

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Hypoglycemia
Insulin

Hypoglycemic Agents
Diabetes Mellitus, Type 1
Glargine
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Immune System Diseases
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Hypoglycemia

Insulin
Pharmacologic Actions
Hypoglycemic Agents
Diabetes Mellitus, Type 1
Glargine
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009