Clinical efficay, pharmacokinetics and pharmacodynamics, and intra-subject variability of insulin Glargine U-300 vs Glargine U-100 in type 1 diabetes.

Clinical efficay, pharmacokinetics and pharmacodynamics, and intra-subject variability of insulin Glargine U-300 vs Glargine U-100 in type 1 diabetes. - GBB17

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002135-17-IT

Enrollment

Registered

2020-12-18

Start date

2016-02-05

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus MedDRA version: 20.0 Level: LLT Classification code 10045234 Term: Type I diabetes mellitus with other specified manifestations System Organ Class: 100000004861

Interventions

Trade Name: Toujeo Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: INSULINA GLARGINE Current Sponsor code: . Other descriptive name: insulin glargine U300 Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects meeting all of the following criteria will be considered for admission to the study: •Aged between 18 and 65 years •Type 1 diabetes mellitus for more than five years •Glycohemoglobin A1C >6.5 and =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria will not to be included in the study: •Diabetes other than type 1 diabetes mellitus •Type 1 diabetic subjects with total insulin dose of ¿ 1 IU/kg/day. •More than one episode of severe hypoglycaemia involving seizure or coma during the past year •Clinically relevant cardiovascular, hepatic, neurologic, endocrine or other major systemic diseases other than type 1 diabetes mellitus which could hinder implementation of the clinical study protocol or interpretation of the study results •History of demonstrable micro- and macro-angiopathic complications •Pregnancy and lactation •History of hypersensitivity to the study medication or to drugs with similar chemical structures •Likelihood of requiring treatment during the study period with any antidiabetic drug other than the drugs to be administered during the study •Progressive fatal diseases •History of drug or alcohol abuse

Design outcomes

Primary

Measure	Time frame
Main Objective: To characterize insulin activity of Glargine U 100 vs insulin Glargine U 300, in subjects with type 1 diabetes in a setting of real life conditions, in order to transfer informations obtained with pharmacokinetic and pharmacodynamic studies into every day clinical practice. ;Secondary Objective: ¿ Dose of insulin Gla-U300 vs Gla-U100. ¿ Risk for nocturnal hypoglycemia ¿ PK/PD and effects on lipid metabolism of Gla U-100 and Gla U-300 ¿ Intra-subject variability of Gla U-300 vs Gla U-100, as calculated from day-to-day pre-dinner PG in the 3 month treatment, and CGM during last week of treatment (also fasting/post-meal PG variability will be calculated); ¿ Intra-subject variability will be also assessed in the PK/PD study and correlated with the above reported clinical variability ;Primary end point(s): To establish the non-inferiority of Gla-U300 to Gla-U100 in lowering pre-injection (pre-dinner) PG.;Timepoint(s) of evaluation of this end point: At the end of the three months of treatment	—

Measure

Time frame

Main Objective: To characterize insulin activity of Glargine U 100 vs insulin Glargine U 300, in subjects with type 1 diabetes in a setting of real life conditions, in order to transfer informations obtained with pharmacokinetic and pharmacodynamic studies into every day clinical practice. ;Secondary Objective: ¿ Dose of insulin Gla-U300 vs Gla-U100. ¿ Risk for nocturnal hypoglycemia ¿ PK/PD and effects on lipid metabolism of Gla U-100 and Gla U-300 ¿ Intra-subject variability of Gla U-300 vs Gla U-100, as calculated from day-to-day pre-dinner PG in the 3 month treatment, and CGM during last week of treatment (also fasting/post-meal PG variability will be calculated); ¿ Intra-subject variability will be also assessed in the PK/PD study and correlated with the above reported clinical variability ;Primary end point(s): To establish the non-inferiority of Gla-U300 to Gla-U100 in lowering pre-injection (pre-dinner) PG.;Timepoint(s) of evaluation of this end point: At the end of the three months of treatment

—

Secondary

Measure	Time frame
Secondary end point(s): ¿ Dose of insulin Gla-U300 vs Gla-U100. ¿ Risk for nocturnal hypoglycemia ¿ PK/PD and effects on lipid metabolism of Gla U-100 and Gla U-300 ¿ Intra-subject variability of Gla U-300 vs Gla U-100, as calculated from day-to-day pre-dinner PG in the 3 month treatment, and CGM during last week of treatment (also fasting/post-meal PG variability will be calculated); ¿ Intra-subject variability will be also assessed in the PK/PD study and correlated with the above reported clinical variability ;Timepoint(s) of evaluation of this end point: na	—

Measure

Time frame

Secondary end point(s): ¿ Dose of insulin Gla-U300 vs Gla-U100. ¿ Risk for nocturnal hypoglycemia ¿ PK/PD and effects on lipid metabolism of Gla U-100 and Gla U-300 ¿ Intra-subject variability of Gla U-300 vs Gla U-100, as calculated from day-to-day pre-dinner PG in the 3 month treatment, and CGM during last week of treatment (also fasting/post-meal PG variability will be calculated); ¿ Intra-subject variability will be also assessed in the PK/PD study and correlated with the above reported clinical variability ;Timepoint(s) of evaluation of this end point: na

—

Countries

Italy

Contacts

Public ContactMISEM

Universit¿ degli Studi di Perugia

francesca.porcellati@unipg.it0755783304

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026