Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Glargine and Lixisenatide.

It had four arms (groups): one (experimental), one (experimental), Placebo - Reference 1 (placebo comparator) and Insulin glargine (Lantus) - Reference 2 (other).

Test 1 will be administered thru subcutaneous (SC) injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition.

Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition.

Reference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition.

The registry classes the interventions as drug.

More on the Plan

The total study duration per patient will be approximately 6 to 13 weeks that will consist of a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and 1-day end of study visit.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 20 years up to 75 years.

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

Examples of who could join: Japanese male or female patients with T2DM diagnosed for at least 1 year prior to the time of screening as established in the medical history. Patients aged 20 to 75 years at screening. Body mass index ≤35 kg/m\^2 at screening. Fasting C-peptide ≥0.6 ng/mL at screening.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: diabetes other than t2dm; history of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening; history of hypoglycemia unawareness.

How the Study Was Run

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

Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Insulin Glargine and the comparison in turn, acting as their own control.

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

It started in 2016-04 with completion listed for 2016-06.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Measurement of plasma glucose concentrations (time frame: 1 day (D1) in each treatment period).

It also tracked 8 secondary outcomes, for example Measurement of serum insulin concentrations, Measurement of serum C-peptide concentrations, Measurement of plasma glucagon concentrations, Measurement of plasma lixisenatide concentrations, Number of patients with hypoglycemic events and Number of patients with adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Glargine and Lixisenatide in 20 people.

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

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 and the Lixisenatide compound page, all human trials.