A Trial to Investigate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BioChaperone® Pramlintide Insulin in Patients With Type 1 Diabetes Mellitus

What Was Tested

This registered phase 1 trial tested Insulin Lispro and Amylin (Islet Amyloid Polypeptide).

It had three arms (groups): BC Pram Ins (experimental), Symlin® and Humulin® (active comparator) and Humalog® (active comparator).

Simultaneous subcutaneous injections avec pramlintide and human insulin.

The registry classes the interventions as drug.

More on the Plan

Each subject will be randomly allocated to a sequence of three treatments:(i) simultaneous administrations of BioChaperone® pramlintide human insulin (BC Pram Ins) and placebo, (ii) simultaneous injections of pramlintide (Symlin®) and human insulin (Humulin®) and (iii) simultaneous injections of insulin lispro (Humalog®) and placebo.

Who Took Part

The registry lists 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male or female subjects aged 18-64 years (both inclusive). Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months. Treated with multiple daily insulin injections ≥ 12 months.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imps, paracetamol (acetaminophen) or related products; type 2 diabetes mellitus; known slowing of gastric emptying, including gastroparesis, and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.

How the Study Was Run

Design: randomized, crossover and triple-blind.

Because people in this Insulin Lispro study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin Lispro and the comparison in turn, acting as their own control.

As a double-blind Insulin Lispro study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2018-04-25 with completion listed for 2019-02-14.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: CmaxPram (time frame: From 0 to 8 hours). AUCPram_0-8h (time frame: From 0 to 8 hours).

It also tracked 4 secondary outcomes, for example Safety and tolerability (Adverse Events recording).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro and Amylin (Islet Amyloid Polypeptide) in 24 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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