Pramlintide in Adolescents With Type 1 Diabetes

Effects of Pramlintide in Adolescents With Type 1 Diabetes

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).

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: pramlintide

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80010
      • Barbara Davis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1 Symlin; Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	Drug: pramlintide; subcutaneous injection (15 mcg initial dose)prior to meals; Other Names: Symlin
NO_INTERVENTION: 2 Usual Regimen; Usual bolus insulin dose at each meal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Amylin Pharmaceuticals, LLC.
• Investigators: Principal Investigator: Peter Chase, MD, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: January 20, 2009
• First Submitted That Met QC Criteria: February 11, 2009
• First Posted (ESTIMATE): February 12, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 23, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: adolescents; type 1 diabetes; post prandial glucose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Pramlintide
• Other Study ID Numbers: 05-0724(2)