Hypoglycemia Counterregulation and Symptom Perception With Insulin Detemir

What Was Tested

The trial (phase 4) is built around Insulin Detemir.

Hypoglycemia and unawareness of hypoglycemia are major problems of insulin therapy in patients with diabetes mellitus.

The long acting insulin analogue Detemir has structural and physicochemical properties which differ from human insulin.

The aim of the present study is to test whether this leads to altered hormone and symptom response during hypoglycemia.

The registry classes the interventions as drug.

Who Took Part

The registry lists 12 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Healthy subjects male or female. Age 18-50 years. Female subjects save contraception. Ability to take part in the study.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: chronic disease; acute disease during 4 weeks prior to the study; drug treatment other than hormonal contraception.

How the Study Was Run

Design: randomized, crossover and single-blind.

The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.

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

In this single-blind Insulin Detemir study one party knew the assignments and the other did not.

It started in 2006-03 with completion listed for 2006-12.

It ran at 1 site in Germany.

What Was Measured

Primary outcome: Hormone response to hypoglycemia (Glucagon). Hormone response to hypoglycemia (glucagon) Symptom response to hypoglycemia.

It also tracked 2 secondary outcomes, for example Hormone response to glucagon (epinephrine, growth hormne, cortisol) and Hormone response (epinephrine, growth hormone, cortisol) to hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir in 12 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Detemir compound page, all human trials.