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

This study has been terminated.
(PI deceased)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00869414
First Posted: March 26, 2009
Last Update Posted: June 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johns Hopkins University
  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 (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 ]
  • Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL. [ Time Frame: 6 weeks ]

Enrollment: 16
Actual Study Start Date: July 2009
Study Completion Date: March 2010
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

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00869414


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: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00869414     History of Changes
Other Study ID Numbers: NA_00024168
First Submitted: March 25, 2009
First Posted: March 26, 2009
Results First Submitted: April 13, 2017
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, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs