Trial Outcomes & Findings for Pramlintide in Adolescents With Type 1 Diabetes (NCT NCT00842075)

NCT ID: NCT00842075

Last Updated: 2015-06-23

Results Overview

HbA1c values 28 days after randomization

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: 28
• Results posted on: 2015-06-23

Participant Flow

10 subjects recruited and completed

no comments

Participant milestones

Measure	1 Symlin Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	2 Usual Regimen Usual bolus insulin dose at each meal
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pramlintide in Adolescents With Type 1 Diabetes

Baseline characteristics by cohort

Measure	1 Symlin n=5 Participants Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	2 Usual Regimen n=5 Participants Usual bolus insulin dose at each meal	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	NA years STANDARD_DEVIATION NA • n=5 Participants	NA years STANDARD_DEVIATION NA • n=7 Participants	15 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 28

Population: pilot study

HbA1c values 28 days after randomization

Outcome measures

Measure	1 Symlin n=5 Participants Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	2 Usual Regimen n=5 Participants Usual bolus insulin dose at each meal
HbA1c Value After 28 Days	7.94 HbA1c % Standard Deviation 0.71	8.72 HbA1c % Standard Deviation 0.44

SECONDARY outcome

Timeframe: 28 days

Mean weight change after 28 days intervention period

Outcome measures

Measure	1 Symlin n=5 Participants Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin	2 Usual Regimen n=5 Participants Usual bolus insulin dose at each meal
Weight Change After 28 Days Intervention Period	-0.84 kg Standard Deviation 0.24	0.04 kg Standard Deviation 0.62

Adverse Events

1 Symlin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2 Usual Regimen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. H. Peter Chase

UColorado

Phone: 303-724-2323

Email: peter.chase@ucdenver.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place