Pramlintide in Adolescents With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
H Peter Chase, University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00842075
First received: January 20, 2009
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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).


Condition Intervention
Type 1 Diabetes
Drug: pramlintide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effects of Pramlintide in Adolescents With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • HbA1c Value After 28 Days [ Time Frame: 28 ] [ Designated as safety issue: No ]
    HbA1c values 28 days after randomization


Secondary Outcome Measures:
  • Weight Change After 28 Days Intervention Period [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Mean weight change after 28 days intervention period


Enrollment: 10
Study Start Date: December 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Symlin
No Intervention: 2 Usual Regimen
Usual bolus insulin dose at each meal

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

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842075

Locations
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80010
Sponsors and Collaborators
University of Colorado, Denver
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Peter Chase, MD University of Colorado, Denver
  More Information

No publications provided by University of Colorado, Denver

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: H Peter Chase, professor of pediatrics, University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00842075     History of Changes
Other Study ID Numbers: duplicate 05-0724
Study First Received: January 20, 2009
Results First Received: September 17, 2012
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
type 1 diabetes
adolescents
post prandial glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pramlintide
Islet Amyloid Polypeptide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014