To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension

What Was Tested

This registered phase 1 trial tested Insulin (regular human).

It had two arms (groups): 1 (active comparator) and 2 (active comparator).

AZD1656.

Insulin.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 12 planned participants were the target.

It was open to men only aged from 20 years up to 45 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy male volunteers. Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator. Have a body mass index (BMI) ≥19 and ≤30.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: daily use of nicotine containing substances.

How the Study Was Run

Design: randomized, crossover and open-label.

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

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-11 with completion listed for 2009-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin (regular human) in 12 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 (regular human) compound page, all human trials.