Pramlintide in Adolescents With Type 1 Diabetes

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT00842075
• Collaborator: Amylin Pharmaceuticals, LLC. (Industry)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• 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: Dec 1, 2006
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. HbA1c Value After 28 Days [28]

   HbA1c values 28 days after randomization

Secondary Outcome Measures

1. Weight Change After 28 Days Intervention Period [28 days]

   Mean weight change after 28 days intervention period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00842075
• Other Study ID Numbers: 05-0724(2)
• First Posted: Feb 12, 2009
• Last Update Posted: Jun 23, 2015
• Last Verified: Sep 1, 2012

• Keywords provided by University of Colorado, Denver: type 1 diabetes; adolescents; post prandial glucose
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Pramlintide

Study Results

Participant Flow

Recruitment Details	10 subjects recruited and completed
Pre-assignment Detail	no comments

Arm/Group Title	1 Symlin	2 Usual Regimen
Arm/Group Description	Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	Usual bolus insulin dose at each meal
Period Title: Overall Study
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	1 Symlin	2 Usual Regimen	Total
Arm/Group Description	Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	Usual bolus insulin dose at each meal	Total of all reporting groups
Overall Participants	5	5	10
Age (Count of Participants)
<=18 years	5 100%	5 100%	10 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	NA (NA)	NA (NA)	15 (2)
Sex: Female, Male (Count of Participants)
Female	3 60%	2 40%	5 50%
Male	2 40%	3 60%	5 50%
Region of Enrollment (participants) [Number]
United States	5 100%	5 100%	10 100%

Outcome Measures

1. Primary Outcome

Title	HbA1c Value After 28 Days
Description	HbA1c values 28 days after randomization
Time Frame	28

Outcome Measure Data

Analysis Population Description

pilot study

Arm/Group Title	1 Symlin	2 Usual Regimen
Arm/Group Description	Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	Usual bolus insulin dose at each meal
Measure Participants	5	5
Mean (Standard Deviation) [HbA1c %]	7.94 (0.71)	8.72 (0.44)

2. Secondary Outcome

Title	Weight Change After 28 Days Intervention Period
Description	Mean weight change after 28 days intervention period
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	1 Symlin	2 Usual Regimen
Arm/Group Description	Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	Usual bolus insulin dose at each meal
Measure Participants	5	5
Mean (Standard Deviation) [kg]	-0.84 (0.24)	0.04 (0.62)

Adverse Events

Arm/Group Title	1 Symlin		2 Usual Regimen
Arm/Group Description	Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin		Usual bolus insulin dose at each meal
All Cause Mortality
	1 Symlin		2 Usual Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	1 Symlin		2 Usual Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	1 Symlin		2 Usual Regimen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.