A Study to Evaluate the Effectiveness and Safety Initiation and Titration of Insulin Glargine (U300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus (T2DM) Controlled on Oral Antidiabetic Drug Treatment in Turkey

What Was Tested

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

Primary Objective: To assess the mean change in HbA1c (glycated haemoglobin).

It had 1 arm (groups): Insulin glargine (U300) (experimental).

The registry classes the interventions as drug.

More on the Plan

The total study duration per patient will be 27 weeks (2 weeks of screening, 24 weeks on treatment, and 1 week follow-up period).

Who Took Part

The registry lists 112 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Adult patients with type 2 diabetes mellitus (≥18 years of age). Type 2 diabetes mellitus diagnosis ≥1 year. Stable antidiabetic treatment for at least 3 months. Willingness to adherence to treatment and titration (including self-injection, self- monitoring blood glucose \[SMBG\]). Signed informed consent obtained.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: age \<18 years old; type 1 diabetes mellitus; having secondary type 2 diabetes mellitus.

How the Study Was Run

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

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

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

It started in 2016-11-30 with completion listed for 2017-12-22.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean change from baseline in HbA1c (time frame: Baseline, Week 24).

It also tracked 7 secondary outcomes, for example Duration to reach target pre-breakfast SMBG, Mean change from baseline in HbA1c, Mean change from baseline in SMBG, Mean change from baseline in fasting plasma glucose (FPG) and Mean change from baseline in Diabetes Treatment Satisfaction Questionnaire (DTSO) scores.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Insulin Glargine in 112 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, all human trials.