Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin

Plain-language guide to NCT02168491: phase 3 interventional trial of Insulin Glargine and Lixisenatide, 10 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02168491
Phase: phase 3
Status: completed
Start: 2014-11
Completion (planned or actual): 2015-07
Participants: 10 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes Mellitus
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Insulin Glargine and Lixisenatide.

Premixed insulin-based therapy is a standard insulin treatment strategy in Austria.

The widespread use of premixed insulin is explained by high acceptance by health care professionals and patients due to one single product and flexible number of injections (1-3 daily) which covers the demand in controlling fasting and postprandial glucose excursions of most patients with diabetes.

It had 1 arm (groups): Intervention group (experimental).

10 type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide.

The registry classes the interventions as drug.

Who Took Part

10 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age 18 - 70a. Subjects understand study related activities and give written informed concent.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: females of child-bearing age; history of hypoglycemia unawareness; impaired liver function (transaminase \>2x than normal).

How the Study Was Run

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

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

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

It started in 2014-11 with completion listed for 2015-07.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in HbA1c From Baseline to End (time frame: 12 weeks).

It also tracked 2 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks) and Change in Body Weight From Baseline to End of Study.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Insulin Glargine and Lixisenatide in 10 people.

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

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

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

Our Notes on the Compounds

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Lixisenatide: A 44-amino-acid once-daily GLP-1 receptor agonist based on exendin-4; sold as Adlyxin/Lyxumia and in Soliqua with insulin glargine.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.