Clinical trial NCT00842075: Pramlintide in Adolescents With Type 1 Diabetes
Official title: Effects of Pramlintide in Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
adolescents
post prandial glucose
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
First posted: 2009-02-12
Enrollment: 10
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c Value After 28 Days
timeFrame: 28
Secondary outcomes:
measure: Weight Change After 28 Days Intervention Period
timeFrame: 28 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Peter Chase, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.