Trial Outcomes & Findings for Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus (NCT NCT00442767)

Results Overview

Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

0 to 240 minutes post-dose

Results posted on

2018-07-10

Participant Flow

Eight study subjects were screened and all subjects completed both study visits.

Participant milestones

Participant milestones
Measure	Insulin Therapy / Pramlintide + Insulin Therapy Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal. Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-meal Insulin Dosing With Adjuvant Pre-meal Pramlintide in Children With Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insulin Therpy / Pramlintide + Insulin Therapy n=8 Participants Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal. Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
Age, Categorical <=18 years	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	16.2 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 240 minutes post-dose

Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone

Outcome measures

Outcome measures
Measure	Rapid Acting Insulin Therapy - Before Meal n=8 Participants Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.	Pre-meal Pramlintide and Post-meal Insulin Therapy n=8 Participants Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone	205 mmol*L/min Standard Error 116	993 mmol*L/min Standard Error 141

SECONDARY outcome

Timeframe: 0 to 120 minutes post-dose

Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone

Outcome measures

Outcome measures
Measure	Rapid Acting Insulin Therapy - Before Meal n=8 Participants Rapid acting Insulin therapy - before meal: Insulin therapy was continued as per prescribed home regimen without pramlintide. Subjects self-administered a rapid-acting insulin analog (aspart or lispro) bolus based on their individual insulin: carbohydrate ratio, before meal.	Pre-meal Pramlintide and Post-meal Insulin Therapy n=8 Participants Pre-meal Pramlintide and Post-meal Insulin therapy: 30mcg of pramlintide was administered subcutaneously immediately prior to the meal and insulin was given 15 minutes after the meal. The dose of insulin was reduced by 20%.
Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.	6060 ng*L/min Standard Error 459	7575 ng*L/min Standard Error 479

Adverse Events

Insulin Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pramlintide + Insulin Therapy

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. Rubina Heptulla

Montefiore Medical Center

Phone: 718-920-4664

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place