Pramlintide in Adolescents With Type 1 Diabetes

NCT ID: NCT00842075

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2009-12-31

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

1 Symlin

Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin

Group Type: EXPERIMENTAL

pramlintide

Intervention Type: DRUG

subcutaneous injection (15 mcg initial dose)prior to meals

2 Usual Regimen

Usual bolus insulin dose at each meal

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pramlintide

subcutaneous injection (15 mcg initial dose)prior to meals

Intervention Type: DRUG

Other Intervention Names

Symlin

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amylin Pharmaceuticals, LLC.

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Chase, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

Barbara Davis Center

Aurora, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 19858155 (View on PubMed)

Other Identifiers

05-0724(2)

Identifier Type: -

Identifier Source: org_study_id