Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Detemir.

An open-label, treat to target, intervention study in order to compare the metabolic control of once to twice-daily insulin Detemir injections in children and adolescence with type 1 diabetes mellitus.

All eligible patients will be assigned to receive insulin Detemir once daily before breakfast.

Short acting insulin analog, Novorapid, will be used for mealtime insulin.

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

Once a day.

Twice a day.

The registry classes the interventions as drug.

More on the Plan

An open label,treat to target, prospective, intervention study in order to compare the metabolic control of once to twice-daily insulin detemir injections in children and adolescence with type 1 diabetes mellitus.

To evaluate Incidence of sever, nocturnal, symptomatic and asymptomatic hypoglycemia and glucose excursions of both hyper and hypoglycemia as measured by the area under the curve determined by the CGMS technique.

Treatment plan: Patients will be assigned to receive insulin detemir once daily before breakfast.

Short acting insulin analog , Novorapid, will be used for mealtime insulin.

Who Took Part

50 planned participants were the target.

It was open to people of any sex aged from 6 years up to 18 years.

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

Examples of who could join: Informed consent obtained before any trial related activity. Children with type 1 diabetes who have been treated with insulin for at least 12 months prior to the study. Age \> 6 years and \< 18 years. Ability and willingness to accept the study conditions and to inject insulin detemir.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: impaired renal function or current renal dialysis; acute or chronic metabolic acidosis, including diabetic ketoacidosis; known hypoglycemia unawareness.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Nothing was hidden in this open-label Insulin Detemir study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-11 with completion listed for 2010-01.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): HbA1C. SBGM (time frame: 4-8 times a day). CGMS (time frame: 72 hours prior to switching to twice daily treatment and at the end of study).

It also tracked 1 secondary outcome, for example documentation of hypoglycemic and hyperglycemic episodes.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Detemir in 50 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, all human trials.