Insulin Analogues and Severe Hypoglycaemia

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Detemir and NPH Insulin (isophane).

Severe hypoglycaemia is hampering the lives of many diabetic patients.

The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated.

In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order.

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

HUman Insulin.

Analogue insulin.

The registry classes the interventions as drug.

More on the Plan

The primary objective is to evaluate the effects of insulin analogue and human insulin on incidence of severe hypoglycaemia in type 1 diabetic patients prone to hypoglycaemia.Secondary endpoints are effect on incidence of symptomatic and asymptomatic documented hypoglycaemia.

Study Design: An open, randomised, controlled, cross-over multi-centre study.

Each treatment period lasts for one year.

Patients will be randomised to treatment with basal bolus therapy with insulin detemir / aspart and insulatard / actrapid in random order.

Who Took Part

The registry lists 179 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 1 diabetes for 5 years. Two or more episodes of hypoglycaemia during the last year,.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: history of addisons disease; growth hormone deficiency or untreated myxoedema; CVD within 6 months.

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 Detemir and who got the comparison, which limits bias.

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

Being open-label, the Insulin Detemir study did not mask who received what.

It started in 2007-05 with completion listed for 2011-11.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Severe hypoglycaemia (time frame: 9 months).

It also tracked 3 secondary outcomes, for example asymptomatic hypoglycaemia, hypoglycaemia during nighttime and hypoglycaemia during daytime.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 179 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.