Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting

What Was Tested

In this phase 4 trial, researchers set out to test Insulin Glargine and Insulin Aspart.

It had two arms (groups): Insulin glargine + Insulin glulisine (experimental) and Premixed insulin (active comparator).

Daily injection of insulin glargine plus one injection of mealtime insulin glulisine at the main meal.

Twice daily premixed insulin (before breakfast and evening meal).

The registry classes the interventions as drug.

Who Took Part

52 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: Patients with type 2 diabetes mellitus treated with insulin glargine once daily and oral blood glucose lowering medication.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: patients treated with an insulin other than insulin glargine; patients with hypersensitivity to insulin glargine, insulin glulisine, biphasic insulin aspart/insulin aspart protamine 30/70 or any of the excipients; patients with a (pre)proliferative retinopathy (an optic fundus examination should have been performed within the 2 years prior to study entry).

How the Study Was Run

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

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

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

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

It started in 2010-01 with completion listed for 2012-07.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Glycosylated Haemoglobin (HbA1c) Value (time frame: at screening (week - 2), week 12 (if available) and 24). Self Measured Blood Glucose (SMBG) (time frame: at Baseline (week 0), week 2, 12 and 24).

It also tracked 5 secondary outcomes, for example DTSQs (Diabetes Treatment Satisfaction Questionnaire - status), DTSQc (Diabetes Treatment Satisfaction Questionnaire - change), ITSQ (Insulin Treatment Satisfaction Questionnaire), Hypoglycemic events and Adverse Events (excluding hypoglycemic events).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Aspart in 52 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.