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PI deceased
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| insulin glargine only in morning | Active Comparator | Morning only administration of insulin glargine |
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| insulin glargine only at evening | Active Comparator | Evening only administration of insulin glargine |
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| split dose insulin glargine | Active Comparator | Split dose administration of insulin glargine, half dose in morning, half dose in evening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evening only administration of insulin glargine | Drug | Evening only administration of insulin glargine, with normal saline injection administered in the morning. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D Saudek, MD | Johns Hopkins University | Principal Investigator |
| Ari S Eckman, MD | Johns Hopkins University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15364161 | Background | 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. | |
| 16911626 |
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This study was prematurely terminated because the P.I. is deceased. Although 16 participants were enrolled, however, the number of participants starting and completing the study as well as the number of participants assigned to each Arm/Group are unknown, since no data are available
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Glargine Only in Morning | Morning only administration of insulin glargine Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night. |
| FG001 | Insulin Glargine Only at Evening |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Morning only administration of insulin glargine | Drug | Morning only administration of insulin glargine, with normal saline injection administered at night. |
|
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| split dose insulin glargine | Drug | split dose of insulin glargine, half administered in the morning, half administered in evening |
|
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| 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. |
Evening only administration of insulin glargine Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning. |
| FG002 | Split Dose Insulin Glargine | Split dose administration of insulin glargine, half dose in morning, half dose in evening split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening |
| COMPLETED |
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| NOT COMPLETED |
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This study was prematurely terminated because the PI is deceased. The Baseline data for the specific arms is unknown since no data are available. Only the baseline data for the overall population is available and reported.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants were randomized to receive one of the three interventions: Insulin glargine only in the morning, Insulin glargine only in the evening, or a split dose of insulin glargine (half the dose in the morning and the other half in the evening). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl) | This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available. | Posted | 6 weeks |
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| Primary | Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL. | This study was prematurely terminated because the P.I. is deceased. The data for the Outcome Measures (if collected) is unknown since no data are available | Posted | 6 weeks |
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This study was prematurely terminated because the P.I. is deceased. The time frame for Adverse Event data (if collected) is unknown since no data are available.
This study was prematurely terminated because the P.I. is deceased. The data for the Adverse Events (if collected) is unknown since no data are available.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Glargine Only in Morning | Morning only administration of insulin glargine Morning only administration of insulin glargine: Morning only administration of insulin glargine, with normal saline injection administered at night. | 0 | 0 | 0 | 0 | ||
| EG001 | Insulin Glargine Only at Evening | Evening only administration of insulin glargine Evening only administration of insulin glargine: Evening only administration of insulin glargine, with normal saline injection administered in the morning. | 0 | 0 | 0 | 0 | ||
| EG002 | Split Dose Insulin Glargine | Split dose administration of insulin glargine, half dose in morning, half dose in evening split dose insulin glargine: split dose of insulin glargine, half administered in the morning, half administered in evening | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Johns Hopkins University Clinical Trials Program | Johns Hopkins University School of Medicine | 410-550-6484 | registerclinicaltrials@jhmi.edu |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Counts |
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| Participants |
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