Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics

What Was Tested

The trial (phase 1) is built around Insulin Glargine.

This trial iss conducted in Europe.

The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.

The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.

It had two arms (groups): IDeg (experimental) and IGlar (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 28 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months. Body mass index 18.0-28.0 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

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

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2009-10 with completion listed for 2010-03.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration (time frame: Within 0-46 hours after last trial product administration).

It also tracked 4 secondary outcomes, for example Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose, Time from start of hypoglycaemic induction until each level of plasma glucose is reached and Hypoglycaemic symptoms score during recovery from hypoglycaemia.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine in 28 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 Glargine compound page, all human trials.