Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, adolescents, post prandial glucose
Brief summary
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).
Detailed description
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: * HbA1c level between 7.5 and 10% inclusive * Currently using carbohydrate to insulin ratio * Acceptable form of birth control Exclusion factors: * Oral hyperglycemic agents or medications which might affect blood sugar levels * Recurrent severe hypoglycemia requiring assistance in previous 6 months * Diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal motility * Previous use of pramlintide 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.
Interventions
DRUGpramlintide
subcutaneous injection (15 mcg initial dose)prior to meals
Sponsors
Amylin Pharmaceuticals, LLC.
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Between 13 and 17 years of age, inclusive * Diagnosed with type 1 diabetes for \> 1 year * Hemoglobin A1c between 7.5 and 10% inclusive * Currently using carbohydrate to insulin ratio * Acceptable form of birth control
Exclusion criteria
* Use of oral hyperglycemic agents or medications affecting blood sugar levels * Recurrent severe hypoglycemia requiring assistance in past 6 months * History of hypoglycemia unawareness * History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility * Previous use of pramlintide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Value After 28 Days | 28 | HbA1c values 28 days after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change After 28 Days Intervention Period | 28 days | Mean weight change after 28 days intervention period |
Countries
United States
Participant flow
Recruitment details
10 subjects recruited and completed
Pre-assignment details
no comments
Participants by arm
| Arm | Count |
|---|---|
| 1 Symlin Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin | 5 |
| 2 Usual Regimen Usual bolus insulin dose at each meal | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | 2 Usual Regimen | 1 Symlin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | NA years | NA years | 15 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
HbA1c Value After 28 Days
HbA1c values 28 days after randomization
Time frame: 28
Population: pilot study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Symlin | HbA1c Value After 28 Days | 7.94 HbA1c % | Standard Deviation 0.71 |
| 2 Usual Regimen | HbA1c Value After 28 Days | 8.72 HbA1c % | Standard Deviation 0.44 |
Secondary
Weight Change After 28 Days Intervention Period
Mean weight change after 28 days intervention period
Time frame: 28 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 Symlin | Weight Change After 28 Days Intervention Period | -0.84 kg | Standard Deviation 0.24 |
| 2 Usual Regimen | Weight Change After 28 Days Intervention Period | 0.04 kg | Standard Deviation 0.62 |