HEAD TO HEAD COMPARISON BETWEEN INSULIN GLARGINE U300 AND INSULIN DEGLUDEC IN TYPE 1 DIABETES

HEAD TO HEAD COMPARISON IN PHARMACOKINETICS AND PHARMACODYNAMICS, AND CLINICAL EFFICACY BETWEEN INSULIN GLARGINE U300 AND INSULIN DEGLUDEC IN TYPE 1 DIABETES - GBB18

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002725-11-IT

Enrollment

Registered

2021-06-08

Start date

2016-09-09

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: 21.1 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: TRESIBA - 100 U/ML-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-CARTUCCIA (VETRO)(PENFILL)- 3 ML - 5 PENFILL Pharmaceutical Form: Solution for injection INN or Proposed INN: INSULINA DEGLUDEC Cu

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) no F.1.3.1 Number of subjects for this age range

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

Secondary

Measure	Time frame
Secondary end point(s): ¿ Dose of insulin Gla-U300 vs Deg ¿ Risk for nocturnal hypoglycemia Gla-U300 vs Deg ¿ PK/PD and effects on lipid metabolism of Gla U-300 and Deg ¿ Intra-subject variability of Gla U300 vs Deg, as calculated from day-to-day pre-dinner PG in the 3 month treatment, and CGM during last two sweek 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: 3 months	—

Measure

Time frame

Secondary end point(s): ¿ Dose of insulin Gla-U300 vs Deg ¿ Risk for nocturnal hypoglycemia Gla-U300 vs Deg ¿ PK/PD and effects on lipid metabolism of Gla U-300 and Deg ¿ Intra-subject variability of Gla U300 vs Deg, as calculated from day-to-day pre-dinner PG in the 3 month treatment, and CGM during last two sweek 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: 3 months

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Primary

Measure	Time frame
Main Objective: To characterize insulin activity of Glargine U300 (Gla U300) vs insulin Degludec (Deg), in subjects with type 1 diabetes ;Secondary Objective: safety (risk reduction of hypoglycemia), clinical efficacy, PD during clamp studies;Primary end point(s): to confirm the non-inferiority of insulin Gla-U300 to insulin Deg in reduction in HbA1c from baseline after three months of treatment.;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: To characterize insulin activity of Glargine U300 (Gla U300) vs insulin Degludec (Deg), in subjects with type 1 diabetes ;Secondary Objective: safety (risk reduction of hypoglycemia), clinical efficacy, PD during clamp studies;Primary end point(s): to confirm the non-inferiority of insulin Gla-U300 to insulin Deg in reduction in HbA1c from baseline after three months of treatment.;Timepoint(s) of evaluation of this end point: 3 months

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Countries

Italy

Contacts

Public ContactMISEM

Universit¿ degli studi di Perugia

francesca.porcellati@unipg.it0755783320

Outcome results

None listed

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