Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment

What Was Tested

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

It had two arms (groups): Gla-300 arm (experimental) and IDeg-100 arm (active comparator).

Gla-300 will be administered once daily for 24 weeks.

Ideg-100 will be administered once daily for 24 weeks.

The registry classes the interventions as drug.

More on the Plan

This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary.

Who Took Part

The registry lists 62 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: Is an adult aged ≥18 years at screening. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period. Is capable of understanding the written informed consent, and provides signed written informed consent. Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements.

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (gip) and glp-1 ra; has a body mass index (bmi)\* \>45 kg/m² during the screening period; has been exposed to other investigational drug(s) within 1 month or 5 half-lives from screening, whichever is longer.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

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

It started in 2022-12-05 with completion listed for 2023-07-28.

It ran at 68 sites in United States (32), Poland (18), Czechia (6), Hungary (6) and Serbia (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100) (time frame: Baseline to 24 weeks).

It also tracked 9 secondary outcomes, for example Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24, Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period, Rate of Hypoglycemia Per Participant-year, Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks) and Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 62 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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