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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Johns Hopkins University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00869414
First received: March 25, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Johns Hopkins University:
hypoglycemia
type 1 diabetes
split dosing insulin glargine
continuous glucose monitoring

Additional relevant MeSH terms:
Insulin
Insulin, Globin Zinc
Insulin, Long-Acting
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Glargine
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 23, 2014