Phase 2, Randomized, Open-Label, Crossover, PD/PK Study of a Novel Pram-Insulin Co-Formulation in Adults With T1D

What Was Tested

This registered phase 2 trial tested Insulin (regular human) and Amylin (Islet Amyloid Polypeptide).

The study comprises 5 visits: Screening (Visit 1), Treatment Periods (Visits 2 - 4), and Follow-Up (Visit 5).

It had six arms (groups): PRAM9 to Regular Insulin to Regular Insulin+pramlintide (experimental), Regular Insulin to Regular Insulin+pramlintide to PRAM9 (experimental), Regular Insulin+pramlintide to PRAM9 to Regular Insulin (experimental), PRAM9 to Regular Insulin+pramlintide to Regular Insulin (experimental) and Regular Insulin to PRAM9 to Regular Insulin+pramlintide (experimental).

Regular Insulin (Humulin®) to Regular Insulin+pamlintide (Symlin® pen) as separate SC injections to PRAM9.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 18 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: Understands the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. Male or non-pregnant, non-lactating female diagnosed with T1D for at least 24 months prior to Screening. Aged 18 to 64 years of age, inclusive. Have a plasma C-peptide level \< 0.6 ng/mL at Screening. Body mass index (BMI) in the range of ≥ 18 to ≤ 35 kg/m2 at Screening.

The full record lists 9 inclusion and 24 exclusion criteria; among the exclusions: currently being treated with pramlintide or has discontinued pramlintide within 21 days of screening; currently using an insulin pump; has hepatic disease, including serum alt or ast ≥3 times the upper limit of normal (uln).

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2019-08-22 with completion listed for 2020-04-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area Under the Curve 0-180 Minutes for Plasma Glucose >[amount hidden]/dL.

It also tracked 12 secondary outcomes, for example Mean Proportional Time for Plasma Glucose Levels, Area Under the Concentration (AUC) Curve for Plasma Glucose, Area Over the Concentration (AOC) Curve for Plasma Glucose, Plasma Glucose Cmax, Plasma Glucose Tmax and Pramlintide Cmax.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) and Amylin (Islet Amyloid Polypeptide) in 18 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.