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Sponsored by: |
Johns Hopkins University |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00869414 |
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 |
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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: | 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 |
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 |
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insulin glargine only in morning: Active Comparator
Morning only administration of insulin glargine
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Drug: Morning only administration of insulin glargine
Morning only administration of insulin glargine, with normal saline injection administered at night.
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insulin glargine only at evening: Active Comparator
Evening only administration of insulin glargine
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Drug: Evening only administration of insulin glargine
Evening only administration of insulin glargine, with normal saline injection administered in the morning.
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split dose insulin glargine: Active Comparator
Split dose administration of insulin glargine, half dose in morning, half dose in evening
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Drug: split dose insulin glargine
split dose of insulin glargine, half administered in the morning, half administered in evening
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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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Christopher D Saudek, MD | 410-955-2132 | csaudek@jhu.edu |
Contact: Ari S Eckman, MD | 410-614-4114 | aeckman1@jhmi.edu |
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Christopher D Saudek, MD | Johns Hopkins University |
Study Director: | Ari S Eckman, MD | Johns Hopkins University |
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 |
hypoglycemia type 1 diabetes split dosing insulin glargine continuous glucose monitoring |
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 |
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 |