Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy

What Was Tested

This registered phase 2 trial tested Insulin Glargine.

This trial is conducted in Europe.

The aim of this trial is to compare NNC0123-0000-0338 (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral antidiabetic therapy.

It had two arms (groups): Oral insulin 338 and subcutaneous placebo (experimental) and Subcutaneous insulin glargine and oral placebo (active comparator).

The registry classes the interventions as drug.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age of 18-70 years (both inclusive) at the time of signing informed consent. Body mass index of 25.0-40.0 kg/m\^2 (both inclusive). Subject diagnosed (clinically) with type 2 diabetes mellitus for at least 180 days prior to the day of screening. Insulin naïve subject; however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to the trial products or related products; any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Glargine.

Those kept unaware of assignments: participant and investigator.

It started in 2015-06-01 with completion listed for 2015-12-31.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in fasting plasma glucose (FPG) (time frame: Week 0, Week 8).

It also tracked 3 secondary outcomes, for example Change from baseline in 10-points plasma glucose profile, Number of treatment emergent hypoglycaemic episodes and area under the serum insulin concentration-time curve.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Glargine 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 Glargine compound page, all human trials.