A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Lispro and Amylin (Islet Amyloid Polypeptide).

This trial is a monocentric, randomised, double-blind, active comparator, controlled, 3-period cross-over trial.

It had three arms (groups): Co-formulation of insulin analog and pramlintide (ADO09) (experimental), Humulin® + Symlin® (active comparator) and Humalog® (active comparator).

Simultaneous, separate subcutaneous injections of human insulin and pramlintide.

The registry classes the interventions as drug.

More on the Plan

IMP administration will be done subcutaneously immediately prior to test meal intake.

Who Took Part

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: Type 1 Diabetes Mellitus (as diagnosed clinically) ≥ 12 months. Treated with multiple daily injection ≥ 12 months. Treated with insulin glargine U100 or U300 or insulin detemir at screening. BMI: 18.5-28.0 kg/m² (both inclusive).

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: known or suspected hypersensitivity to imps, paracetamol 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

It was run as a randomized, crossover and triple-blind study.

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.

Each person switched between Insulin Lispro and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Lispro.

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

It started in 2019-01-04 with completion listed for 2019-03-01.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: CmaxPram (time frame: From 0 to 8 hours). AUCPram 0-8h (time frame: From 0 to 8 hours). CmaxIns (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.