Dose Response of Dance 501 in Subjects With Type 2 Diabetes Mellitus

Plain-language guide to NCT04100473: phase 2 randomized trial of Insulin (regular human) and Insulin Lispro, 24 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT04100473
Phase: phase 2
Status: completed
Start: 2018-04-23
Completion (planned or actual): 2018-08-11
Participants: 24 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes Mellitus
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Insulin (regular human) and Insulin Lispro.

This will be a randomized, open-label, active-controlled, 6-period crossover study.

Target population will be subjects with Type 2 Diabetes Mellitus (T2DM).

It had two arms (groups): one (experimental) and Insulin Lispro (active comparator).

Insulin Lispro (Humalog®) will be administered by subcutaneous injection.

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Subjects diagnosed with T2DM. BMI between 25.0 and 40.0 kg/m2. Treated with metformin and/or at least 1 daily injection of insulin for at least 6 months. Non-smoker for at least 5 years.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: any condition affecting pulmonary drug absorption; history or presence of cancer except basal cell skin cancer or squamous cell skin cancer; proliferative retinopathy and/or severe neuropathy.

How the Study Was Run

Design: randomized, crossover and open-label.

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

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2018-04-23 with completion listed for 2018-08-11.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) and Insulin Lispro in 24 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 (regular human) compound page and the Insulin Lispro 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 Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.

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.