Regulation of Endogenous Glucose Production by Brain Insulin Action

What Was Tested

The trial (phase 1) is built around Insulin Lispro for insulin resistance, prediabetes & type 2 diabetes.

The researchers aim to test whether this is true in humans by giving insulin intranasally.

It had two arms (groups): Intranasal insulin (experimental) and Intranasal placebo (placebo comparator).

Placebo comparator to intranasal insulin.

The registry classes the interventions as drug.

More on the Plan

Each study participant will be admitted to hospital the evening prior to the study.

Following admission each study participant will be provided with a standardized dinner.

At the same time (7am) a pancreatic clamp will be started as described above for 8 hours.

Blood samples will be analysed with a glucometer for instant blood glucose readings At 9 am (+120 minutes) intranasal placebo or insulin will be administered.

Who Took Part

The registry lists 8 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Men and women, aged 18 to 60 years. Body mass index 20-27. Hemoglobin in the normal range. Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study.

The full record lists 5 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and single-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.

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

Only one side, usually the insulin resistance, prediabetes & type 2 diabetes participants, was kept unaware of whether Insulin Lispro was given.

Those kept unaware of assignments: participant.

It started in 2013-11 with completion listed for 2014-07.

It ran at 1 site in Canada.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Endogenous glucose production (time frame: 8 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Lispro in 8 people with insulin resistance, prediabetes & type 2 diabetes.

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, Insulin resistance, prediabetes & type 2 diabetes research.