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PI left University of Miami
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Basal-bolus insulin therapy, which includes one injection of long acting insulin and three injections of short acting insulin is the most commonly used insulin treatment. However, many older patients find the basal-bolus insulin regimen hard to manage because it involves 4 injections and 4 blood glucose tests each day. It is possible that a simplified treatment that involves one injection of long acting insulin daily and two blood glucose tests daily might be equally effective. This simplified regimen, if effective, would be easier to use and might result in less errors. Therefore, the investigators want to conduct this study to compare using a single daily injection of basal insulin with the usual basal-bolus insulin regimen in elderly patients (age >65 years) with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Subcutaneous Injection (MSI) | Active Comparator | MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro. |
|
| Basal Insulin (BI) | Experimental | BI group will receive only one injection of insulin glargine in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | 0.40 units/kg body weight |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c (HbA1c) | The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Any Hypoglycemia | Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups | 6 months |
| Incidence of Severe Hypoglycemia | Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups. |
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Inclusion Criteria:
-Age >65 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Garg, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | South Miami | Florida | 33143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Multiple Subcutaneous Injection (MSI) | Multiple Subcutaneous Injection (MSI) group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro. Insulin Glargine: 0.20 units/kg body weight Insulin Aspart: 0.20 units/kg body weight Insulin Lispro: 0.20 units/kg body weight |
| FG001 | Basal Insulin (BI) | Basal Insulin (BI) group will receive only one injection of insulin glargine in the morning. Insulin Glargine: 0.40 units/kg body weight |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Multiple Subcutaneous Injection (MSI) | MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro. Insulin Glargine: 0.20 units/kg body weight Insulin Aspart: 0.20 units/kg body weight Insulin Lispro: 0.20 units/kg body weight |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Hemoglobin A1c (HbA1c) | The mean HbA1c in the BI group will be compared to the mean HbA1c in the MSI group | Posted | Mean | Full Range | percentage of HbA1c | 6 months |
|
6 months
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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 | Multiple Subcutaneous Injection (MSI) | MSI group will receive four insulin injections per day that will include a long acting and a short acting insulin. Short acting insulin will be either insulin aspart or insulin lispro. Insulin Glargine: 0.20 units/kg body weight Insulin Aspart: 0.20 units/kg body weight Insulin Lispro: 0.20 units/kg body weight |
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This study was terminated and there was insufficient patient data for statistical analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajesh Garg | The Lundquist Research Institute | 310-222-1968 | rajesh.garg@lundquist.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2023 | Nov 20, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D061267 | Insulin Aspart |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin Glargine |
| Drug |
0.20 units/kg body weight |
|
| Insulin Aspart | Drug | 0.20 units/kg body weight |
|
| Insulin Lispro | Drug | 0.20 units/kg body weight |
|
| 6 months |
| BG001 |
| Basal Insulin (BI) |
BI group will receive only one injection of insulin glargine in the morning. Insulin Glargine: 0.40 units/kg body weight |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| HbA1c | Mean | Full Range | % |
|
|
|
| Secondary | Incidence of Any Hypoglycemia | Defined as any reported blood glucose (BG) <70 mg/dl will be compared between the two groups | Posted | Number | participants | 6 months |
|
|
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| Secondary | Incidence of Severe Hypoglycemia | Any BG <54 mg/dl or patient requiring assistance to recover from hypoglycemia will be compared between 2 groups. | Posted | Number | participants | 6 months |
|
|
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| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Basal Insulin (BI) | BI group will receive only one injection of insulin glargine in the morning. Insulin Glargine: 0.40 units/kg body weight | 0 | 4 | 0 | 4 | 0 | 4 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |