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

What Was Tested

The trial (phase 4) is built around Insulin (regular human) and Amylin (Islet Amyloid Polypeptide).

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.

It had two arms (groups): Rapid acting Insulin therapy - before meal (active comparator) and Pre-meal Pramlintide and Post-meal Insulin therapy (experimental).

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.

The registry classes the interventions as drug.

More on the Plan

Following approval by the Institutional Review Board at Baylor College of Medicine 8 adolescents (6 males, 2 females) with type 1 diabetes were recruited to the open-labeled, non-randomized, crossover study.

Two male subjects were African American; the remaining subjects were all Caucasian.

Six subjects were on insulin pump therapy, and the two on insulin glargine, self-administered at -90minutes.

Study A was done before study B.

Who Took Part

8 actual participants took part.

It was open to people of any sex aged from 12 years up to 21 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 1 diabetes only. Diagnosed with T1DM for at least 1 year. Currently treated using insulin glargine with or without Humalog/ Novolog or on the insulin pump. Otherwise healthy, EXCEPT for T1DM and treated hypothyroidism. Negative pregnancy test, in the case of females.

The full record lists 7 inclusion and 8 exclusion criteria; among the exclusions: lack of supportive family; evidence or history of chemical abuse; BMI (body mass index) greater than the 90th percentile OR less than the 10th percentile for age.

How the Study Was Run

The set-up was non-randomized, crossover and open-label.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2007-02 with completion listed for 2009-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.

It also tracked 1 secondary outcome, for example Measure of Glucagon Concentration in Subjects Treated With Pramlintide + Insulin, Compared to Insulin Alone.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin (regular human) and Amylin (Islet Amyloid Polypeptide) in 8 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page and the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.