Comparison of Insulin Detemir and NPH With Respect to Lowering the Blood Sugar and Symptoms Experienced by Type 1 Diabetics During Hypoglycaemia

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Detemir and NPH Insulin (isophane).

This trial is conducted in UK.

The aim of this clinical trial is to investigate lowering the blood sugar and symptoms experienced during hypoglycaemia.

The registry classes the interventions as drug.

Who Took Part

The registry lists 25 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: Signed and dated informed consent obtained before any trial-related activities. Type 1 diabetes. Treatment with insulin for minimum three months. Duration of diabetes for more than 12 months. Body Mass Index (BMI) less than 30 kg/m2.

The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: participation in any other clinical trial involving other investigational products within the last three months; hypoglycaemic unawareness or severe autonomic neuropathy; current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and mao inhibitors.

How the Study Was Run

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

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

In the crossover set-up each of the participants took both Insulin Detemir and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2004-04 with completion listed for 2005-10.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration based on the Edinburgh Hypoglycaemia Scale: autonomic symptoms, neuroglycopenic symptoms and general malaise (time frame: From -40 min and until immediately before trial product administration).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 25 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 Detemir compound page and the NPH Insulin (isophane) compound page, all human trials.