Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

Plain-language guide to NCT01486940: phase 3 randomized trial of Insulin (regular human) and Insulin Aspart, 598 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01486940
Phase: phase 3
Status: completed
Start: 2002-03
Completion (planned or actual): 2002-10
Participants: 598 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Diabetes; Diabetes Mellitus, Type 1
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Insulin (regular human) and Insulin Aspart.

This trial is conducted in Europe and South America.

The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

It had two arms (groups): Basal/bolus regimen 1 (experimental) and Basal/bolus regimen 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 598 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 at least 12 months. Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months. BMI below or equal to 35 kg/m\^2.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: proliferative retinopathy or maculopathy requiring acute treatment; recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator); subjects with known hypoglycaemic unawareness as judged by the investigator.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.

The Insulin (regular human) group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.

It started in 2002-03 with completion listed for 2002-10.

It ran at 75 sites in Italy (14), France (11), Denmark (9), Czechia (7), Finland (7) and Norway (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: HbA1c (glycosylated haemoglobin).

It also tracked 4 secondary outcomes, for example Intra-subject variation in home measured blood glucose (3-point blood glucose profiles), 8-point blood glucose profiles, Incidence of self-recorded hypoglycaemic episodes and Incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Aspart in 598 people.

With 598 participants it is a large trial for this field.

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

More context: the Insulin (regular human) compound page and the Insulin Aspart compound page, all human trials.

Our Notes on the Compounds

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.

Insulin Detemir: A long-acting basal insulin analog sold as Levemir.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.