At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 8 enrolled

Drug / intervention

Insulin +1 moredrug

Likely dose

Pramlintide + Insulin 30mcgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00442767

NCT00442767Phase 4Completed

Compare CT.gov

Reducing Postprandial Hyperglycemia With Adjuvant Premeal Pramlintide and Postmeal Insulin in Children With Type 1 Diabetes Mellitus.

Montefiore Medical Center·interventional·Posted Mar 2, 2007·Updated Jul 10, 2018

In Brief

A Phase 4 clinical trial evaluating Insulin and Pramlintide + Insulin for Type 1 Diabetes Mellitus. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsType 1 Diabetes Mellitus

CountriesUnited States

CollaboratorsAmylin Pharmaceuticals, LLC.

Timeline

Phase 4CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2007

First PostedMar 2007

Primary CompletionFeb 2009

TodayJul 2026

First PostedMar 2, 2007

Enrollment StartFeb 1, 2007

Primary CompletionFeb 1, 2009

TodayJul 2, 2026

Enrollment to primary: 2 yearsPosted 19.3 years ago

Interventions

Insulindrug

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.

Pramlintide + Insulindrug

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%.