A Study of Insulin Lispro Mix in Type 2 Diabetic Asian Patients

What Was Tested

The trial (phase 4) is built around Insulin Lispro.

It had 1 arm (groups): Lispro 50/50 (experimental).

The registry classes the interventions as drug.

More on the Plan

A multicenter, non-randomized, open-label, post-marketing clinical study.

The target population of the study is type 2 diabetic patients who have failed to achieve adequate glycemic control on OADs.

The study consists of 4 periods: Lead-in Period (2 to 4 weeks), Study Period I (16 weeks), Study Period II (16 weeks), and Study Period III (16 weeks).

The regimen of lispro mix 50/50 injection will be changed every 16 weeks based on the HbA1c level.

Who Took Part

135 actual participants took part.

It was open to people of any sex aged from 20 years up to 80 years.

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

Examples of who could join: Patients diagnosed as having type 2 Diabetes. Patients who have not been on insulin treatment within 6 months. Patients who have been taking OADs for at least 90 days. Patients with a Body-Mass Index (BMI) of 35 kg/m² or below.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: patients having pre-proliferative or proliferative retinopathy (except for old retinopathy with no need for treatment); patients having or suspected of having malignancy; patients having serious complications of the heart, liver, or kidney.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-09 with completion listed for 2011-04.

It ran at 14 sites in Japan (14).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 12 secondary outcomes, for example Change From Baseline in Hemoglobin A1c (HbA1c) at Week 48 Endpoint, Change From Baseline in Fasting Glucose at Week 48 Endpoint, Change From Baseline in Blood Glucose Profile at Week 48 Endpoint, Change From Baseline in Fasting C-Peptide at Week 48 to Endpoint, Change From Baseline in Fasting Serum Lipids at Week 48 Endpoint and Change From Baseline in Body Weight at Week 48 Endpoint.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Insulin Lispro in 135 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Lispro compound page, all human trials.