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Trial record 30 of 1009 for:    Area Under Curve AND insulin

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

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ClinicalTrials.gov Identifier: NCT00442767
Recruitment Status : Completed
First Posted : March 2, 2007
Results First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Rubina Heptulla, Montefiore Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus
Interventions Drug: Insulin
Drug: Pramlintide + Insulin
Enrollment 8
Recruitment Details Eight study subjects were screened and all subjects completed both study visits.
Pre-assignment Details  
Arm/Group Title Insulin Therapy / Pramlintide + Insulin Therapy
Hide Arm/Group Description

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%.

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Insulin Therpy / Pramlintide + Insulin Therapy
Hide Arm/Group Description

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 Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
8
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
16.2  (1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
2
  25.0%
Male
6
  75.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
 100.0%
1.Primary Outcome
Title Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone
Hide Description Blood glucose concentration in terms of mean AUC (0 to 240 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone
Time Frame 0 to 240 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rapid Acting Insulin Therapy - Before Meal Pre-meal Pramlintide and Post-meal Insulin Therapy
Hide Arm/Group Description:
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 Number of Participants Analyzed 8 8
Mean (Standard Error)
Unit of Measure: mmol*L/min
205  (116) 993  (141)
2.Secondary Outcome
Title Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.
Hide Description Glucagon concentration in terms of mean AUC (0 to 120 minutes) was determined in subjects treated with Pramlintide + Insulin vs. Insulin alone
Time Frame 0 to 120 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rapid Acting Insulin Therapy - Before Meal Pre-meal Pramlintide and Post-meal Insulin Therapy
Hide Arm/Group Description:
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 Number of Participants Analyzed 8 8
Mean (Standard Error)
Unit of Measure: ng*L/min
6060  (459) 7575  (479)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin Therapy Pramlintide + Insulin Therapy
Hide Arm/Group Description 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%.
All-Cause Mortality
Insulin Therapy Pramlintide + Insulin Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Therapy Pramlintide + Insulin Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Insulin Therapy Pramlintide + Insulin Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%) 
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.
Results Point of Contact
Name/Title: Dr. Rubina Heptulla
Organization: Montefiore Medical Center
Phone: 718-920-4664
Responsible Party: Rubina Heptulla, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00442767     History of Changes
Other Study ID Numbers: H-18629
GCRC protocol #:0954
First Submitted: March 1, 2007
First Posted: March 2, 2007
Results First Submitted: March 13, 2018
Results First Posted: July 10, 2018
Last Update Posted: July 10, 2018