The Effect of Soliqua on Glucose Variability in Type 2 Patients Among South Asians

What Was Tested

This registered phase 4 trial tested Insulin Glargine and Lixisenatide.

It had two arms (groups): Insulin Glargine + GLP-1 RA (experimental) and Basaglar/Lantus + gliclazide MR (active comparator).

The registry classes the interventions as drug.

More on the Plan

After giving informed consent and being assessed by eligibility, the patient will stop other oral hypoglycemic agents except metformin (SGLT2 inhibitor may be continued if the patient has cardiovascular diseases history) and enter a 1-week run-in phase with Basaglar or Lantus insulin.

The secondary outcomes include the differences on other measurements of glucose variability and patient-reported outcomes (PROs).

Who Took Part

The registry lists 119 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Male and female adults with clinical diagnosis of T2DM diagnosed at least 1 year before screening and in stable health as assessed by investigator. Age between 18 and 80 years (inclusive). Body mass index (BMI) between 20-40 kg/m2 (inclusive). Insulin naïve, uncontrolled on oral hypoglycemic medications. Written informed consent obtained.

The full record lists 9 inclusion and 19 exclusion criteria; among the exclusions: history of insulin use (except emergency short-term use defined as less than 12 weeks for acute illness, hospitalization, pregnancy or with steroid use); use of glp-1 receptor agonist in the past 3 months; pregnant or anticipating pregnancy.

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.

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

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

It started in 2018-10-02 with completion listed for 2019-11-19.

It ran at 3 sites in Canada (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time in range at week 13 (time frame: 7 days). Time in range within 12-hours (6 AM -6 PM) at week 13 (time frame: 7 days).

It also tracked 28 secondary outcomes, for example Daily glucose standard deviation (SD) at week 13, Overall SD of CGM glucose at week 13, Mean of glucose at week 13, Frequency of hypoglycemia at week 13, Time in hypoglycemia at week 13 and Frequency of hyperglycemia at week 13.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine and Lixisenatide in 119 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 and the Lixisenatide compound page, all human trials.