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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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This study aims to compare the post-meal blood glucose values of two drugs in a "real-world" setting.
This is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog) insulin in a real-world setting. Children participating in the Florida Camp for Children and Youth with Diabetes will be randomized to receive either Glulisine or Apidra to cover carbohydrates after meals. The difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Humalog | Active Comparator | Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. |
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| Apidra | Active Comparator | Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. |
|
| Novolog | Active Comparator | Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apidra | Drug | Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch. | Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona. | averaged over 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner | Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet Silverstein, M.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Camp Winona | DeLeon Springs | Florida | 32130 | United States |
There were 107 participants consented to the study. 8 participants were withdrawn prior to randomization to the study.
The study was conducted at the Florida Camp for Children & Youth with Diabetes during the summers of 2011 and 2012. In the summer of 2012 an additional arm was added to the study to include Novolog.
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| ID | Title | Description |
|---|---|---|
| FG000 | Humalog | Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. |
| FG001 | Apidra | Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. |
| FG002 | Novolog | Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
In the first year (Camp 2011) there were 2 arms, the Humalog and Apidra. In the second year (Camp 2012) there were 3 arms, the Humalog, Apidra, and Novolog. Therefore, there will be more participants in the Humalog and Apidra arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | Humalog | Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. |
| BG001 | Apidra |
| 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 | The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch. | Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona. | Post-Prandial Blood Glucose Values [Within 90 minutes following the completion of participant lunch] | Posted | Mean | Standard Deviation | mg/dl | averaged over 5 days |
|
July 2011 through July 2012
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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 | Humalog | Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemic Event | Endocrine disorders | MedDRA (10.0) | Systematic Assessment | The participants have a diagnosis of diabetes. A hypoglycemic event is not an unusual occurrence for them to experience. |
In the first year (Camp 2011) there were 2 arms, the Humalog and Apidra. In the second year (Camp 2012) there were 3 arms, the Humalog, Apidra, and Novolog. Therefore, there will be more participants in the Humalog and Apidra arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Silverstein, MD | University of Florida | 352-334-1390 | silvejh@peds.ufl.edu |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C479079 | insulin glulisine |
| D061268 | Insulin Lispro |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Humalog | Drug | Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. |
|
|
| Novolog | Drug | Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.) |
|
|
| averaged over 5 days |
| Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast | Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. | averaged over 5 days |
Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
| BG002 | Novolog | Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Apidra | Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. |
| OG002 | Novolog | Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.) |
|
|
|
| Secondary | Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner | Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. | Posted | Mean | Standard Deviation | mg/dl | averaged over 5 days |
|
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|
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| Secondary | Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast | Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. | Posted | Mean | Standard Deviation | mg/dl | averaged over 5 days |
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| 0 |
| 41 |
| 41 |
| 41 |
| EG001 | Apidra | Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. | 0 | 40 | 40 | 40 |
| EG002 | Novolog | Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.) | 0 | 18 | 18 | 18 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |