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Pramlintide in Adolescents With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00842075
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : October 19, 2012
Last Update Posted : June 23, 2015
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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).


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: pramlintide Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effects of Pramlintide in Adolescents With Type 1 Diabetes
Study Start Date : December 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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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 Name: Symlin
No Intervention: 2 Usual Regimen
Usual bolus insulin dose at each meal


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c Value After 28 Days [ Time Frame: 28 ]
    HbA1c values 28 days after randomization


Secondary Outcome Measures :
  1. Weight Change After 28 Days Intervention Period [ Time Frame: 28 days ]
    Mean weight change after 28 days intervention period


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00842075


Locations
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United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80010
Sponsors and Collaborators
University of Colorado, Denver
Amylin Pharmaceuticals, LLC.
Investigators
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Principal Investigator: Peter Chase, MD University of Colorado, Denver
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00842075    
Other Study ID Numbers: 05-0724(2)
First Posted: February 12, 2009    Key Record Dates
Results First Posted: October 19, 2012
Last Update Posted: June 23, 2015
Last Verified: September 2012
Keywords provided by University of Colorado, Denver:
type 1 diabetes
adolescents
post prandial glucose
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Pramlintide
Hypoglycemic Agents
Physiological Effects of Drugs