Pramlintide in Adolescents With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Pramlintide in Adolescents With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: pramlintide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 Symlin<br>Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin | Drug: pramlintide<br>* subcutaneous injection (15 mcg initial dose)prior to meals<br>* Other names: Symlin;|
| No Intervention: 2 Usual Regimen<br>Usual bolus insulin dose at each meal | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c Value After 28 Days | HbA1c values 28 days after randomization | 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Change After 28 Days Intervention Period | Mean weight change after 28 days intervention period | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, adolescents, post prandial glucose