Pramlintide in Adolescents With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Effects of Pramlintide in Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842075
• Other study ID #: 05-0724(2)
• Status: Completed
• Phase: N/A
• First received: January 20, 2009
• Last updated: May 26, 2015
• Start date: December 2006
• Est. completion date: December 2009

Study information

• Verified date: September 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• pramlintide
subcutaneous injection (15 mcg initial dose)prior to meals

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Amylin Pharmaceuticals, LLC.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Value After 28 Days	HbA1c values 28 days after randomization	28	No
Secondary	Weight Change After 28 Days Intervention Period	Mean weight change after 28 days intervention period	28 days	No