A Study Evaluating Safety and Efficacy of BIOD 531 Compared to Humalog® Mix 75/25 in Subjects With Type 2 Diabetes

What Was Tested

In this phase 2 trial, researchers set out to test Insulin Lispro.

It had two arms (groups): BIOD-531 (experimental) and Humalog® Mix 75/25 (active comparator).

BIOD-531 injected twice daily.

Humalog® Mix 75/25 injected twice daily.

The registry classes the interventions as drug.

More on the Plan

The purpose of this trial is to evaluate glucose control and safety of BIOD-531 compared to a pre-mixed insulin which is commonly used to provide both meal-time and long acting insulin.

Who Took Part

The registry lists 13 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: Established clinical diagnosis of type 2 diabetes, consistent with ADA classification criteria for 6 months or longer. Body Mass Index 27 - 45 kg/square meter, inclusive.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: regular use of humulin®r u-500 or sulfonylurea, exenatide (short-acting), repaglinide, or nateglinide within 1 month prior to screening; history of bariatric surgery; history of known hypersensitivity to any of the components in the study medication.

How the Study Was Run

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

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

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

Being open-label, the Insulin Lispro study did not mask who received what.

It started in 2015-05 with completion listed for 2016-02.

It ran at 7 sites in United States (7).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c (time frame: 18 weeks).

It also tracked 3 secondary outcomes, for example Postprandial glucose excursions, Change in weight and Hypoglycemic event rates.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin Lispro in 13 people.

Its size is small, so on its own it can only give an early look.

Its status is suspended; no results are posted to the registry yet, so nothing here describes outcomes.

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