Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Amylin Pharmaceuticals, LLC. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes.
This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).
Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are:
Exclusion factors:
The study consists of 2 overnight stays at the CTRC where a continuous glucose monitoring system will be worn for twenty-four hours. Blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal. Meals will be controlled for carbohydrate, fat and protein content. Meals will be identical at each CTRC visit.
After a baseline visit for all participants, randomization will occur to either Treatment or Control.Bolus insulin will be adjusted for participants when beginning pramlintide and will likely remain at a reduced rate throughout the trial. All participants will have access to staff to assist with insulin dosing. There will be six mandatory phone visits over the 36 days to ensure the safety of participants in this study.
Insulin, glucose and glucagon levels will be assessed as well as pramlintide levels at final visit of the study. Hypoglycemic events will be tracked, as well as any other adverse events.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 Symlin | Experimental | Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin |
|
| 2 Usual Regimen | No Intervention | Usual bolus insulin dose at each meal |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pramlintide | Drug | subcutaneous injection (15 mcg initial dose)prior to meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Value After 28 Days | HbA1c values 28 days after randomization | 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change After 28 Days Intervention Period | Mean weight change after 28 days intervention period | 28 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Chase, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center | Aurora | Colorado | 80010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19858155 | Derived | Kishiyama CM, Burdick PL, Cobry EC, Gage VL, Messer LH, McFann K, Chase HP. A pilot trial of pramlintide home usage in adolescents with type 1 diabetes. Pediatrics. 2009 Nov;124(5):1344-7. doi: 10.1542/peds.2008-3750. Epub 2009 Oct 26. |
Not provided
Not provided
no comments
10 subjects recruited and completed
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1 Symlin | Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin |
| FG001 | 2 Usual Regimen | Usual bolus insulin dose at each meal |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1 Symlin | Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin |
| BG001 | 2 Usual Regimen | Usual bolus insulin dose at each meal |
| 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 | HbA1c Value After 28 Days | HbA1c values 28 days after randomization | pilot study | Posted | Mean | Standard Deviation | HbA1c % | 28 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 Symlin | Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. H. Peter Chase | UColorado | 303-724-2323 | peter.chase@ucdenver.edu |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C105254 | pramlintide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Weight Change After 28 Days Intervention Period | Mean weight change after 28 days intervention period | Posted | Mean | Standard Deviation | kg | 28 days |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 2 Usual Regimen | Usual bolus insulin dose at each meal | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |