Toujeo Versus NPH Self-titration Study

What Was Tested

This registered phase 4 trial tested Insulin Glargine.

This is a 24 week, multicentre, prospective, randomized, controlled, parallel-designed (1:1) pilot study.The study will compare glycemic variability in patients treated with insulin glargine U300/ml insulin versus conventional (NPH) insulin using a self titration algorithm.50 type 2 diabetes patients who are newly started on insulin will be recruited.

They will be randomly allocated to either insulin glargine U300 or NPH insulin for 26 weeks.

All subjects will follow a insulin-self titration algorithm.

It had two arms (groups): Active (experimental) and Control (active comparator).

Neutral Protamine Hagedorn insulin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 50 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: Type 2 diabetic suboptimally controlled on their previous antidiabetic treatment. 18 ≤ age ≤ 75. The number of OADs that the patients used should be "3" or less. BMI \< 40 kg/m2. Patient who is capable and willing to perform regular SMBG.

The full record lists 11 inclusion and 10 exclusion criteria; among the exclusions: participation in a clinical trial with any investigational drug used with curative intent and within 30 days prior to study entry; patient known to have hypoglycaemia unawareness or recurrent major hypoglycaemia; any product containing prandial insulin.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

In this single-blind Insulin Glargine study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2018-01-01 with completion listed for 2019-12-17.

It ran at 1 site in Hong Kong.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Glycemic variability (time frame: 24 weeks).

It also tracked 9 secondary outcomes, for example Glycemic variability, Percentage time in target, Glycated haemoglobin, Fasting blood glucose, Incidence of hypoglycemia and Treatment satisfaction.

What This Means in Plain Language

Put simply, this is a phase 4, 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.