Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes

Plain-language guide to NCT00725036: phase 3 randomized trial of Insulin (regular human) and Insulin Aspart, 305 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00725036
Phase: phase 3
Status: completed
Start: 2002-09-02
Completion (planned or actual): 2004-12-14
Participants: 305 (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

This registered phase 3 trial tested Insulin (regular human) and Insulin Aspart.

This trial is conducted in Oceania.

The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.

The registry classes the interventions as drug.

Who Took Part

The registry lists 305 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. Current treatment with any insulin in any regimen. Body mass index (BMI) below 38.0 kg/m2.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: current acute or chronic pulmonary disease (excluding asthma); recurrent major hypoglycaemia; proliferative retinopathy or maculopathy requiring acute treatment.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

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

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2002-09-02 with completion listed for 2004-12-14.

It ran at 18 sites in Australia (18).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Long term pulmonary safety profiles (time frame: during treatment).

It also tracked 6 secondary outcomes, for example Glycaemic control as measured by HbA1c, Incidence of hypoglycaemic episodes, Long-term safety profiles (laboratory, ECG, insulin antibodies), Physical examination and body weight and vital signs, Adverse events and Treatment satisfaction.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Aspart in 305 people.

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.

NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).

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.