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

NCT00442767 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-07-10

Study results available
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Summary

The primary objective of this study is to examine the effect of pramlintide given pre-meal and insulin given just after a meal vs. standard therapy of pre-meal insulin on post-prandial glucose excursions.

The secondary objective is to examine the effect of pramlintide and insulin on glucagon suppression in type 1 diabetes.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Insulin

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.

DRUG

Pramlintide + Insulin

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%.

Sponsors & Collaborators

  • Amylin Pharmaceuticals, LLC.

    collaborator INDUSTRY

  • Montefiore Medical Center

    lead OTHER

Principal Investigators

  • Rubina A Heptulla, MD · Montefiore Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442767 on ClinicalTrials.gov