A Study of LY3209590 in Participants With Type 1 Diabetes

A Phase 2, Randomized, Parallel, Open-Label Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 1 Diabetes Mellitus Previously Treated With Multiple Daily Injection Therapy

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003589-41-ES

Enrollment

357

Registered

2020-02-28

Start date

2020-05-04

Completion date

Unknown

Last updated

2020-11-16

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

Conditions

Diabetes Mellitus, Type 1 MedDRA version: 21.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861

Interventions

Product Name: LY3209590 Product Code: LY3209590 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: LY3209590 Other descriptive name: LY3209590 Concentration unit: mg/ml millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year. • Participants must have been using multiple daily injections without interruption for at least 3 months. • Participants must have HbA1c value of =9.5%. • Participants must have a body mass index (BMI) of =35 kilograms per meter squared (kg/m²). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 328 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29

Exclusion criteria

Exclusion criteria: • Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening. • Participants must not have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening. • Participants must not have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke). • Participants must not have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease. • Participants must not have estimated glomerular filtration rate (eGFR) 14 days) systemic glucocorticoid therapy.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of 2 dosing algorithms on the efficacy of LY3209590 compared with insulin degludec in study participants with T1DM;Secondary Objective: - To investigate the safety of LY3209590 compared with insulin degludec in study participants with T1DM - To characterize the PK of LY3209590 in study participants with T1DM;Primary end point(s): Change from Baseline in Hemoglobin A1c (HbA1c);Timepoint(s) of evaluation of this end point: Week 26	—

Measure

Time frame

Main Objective: To investigate the effect of 2 dosing algorithms on the efficacy of LY3209590 compared with insulin degludec in study participants with T1DM;Secondary Objective: - To investigate the safety of LY3209590 compared with insulin degludec in study participants with T1DM - To characterize the PK of LY3209590 in study participants with T1DM;Primary end point(s): Change from Baseline in Hemoglobin A1c (HbA1c);Timepoint(s) of evaluation of this end point: Week 26

—

Secondary

Measure	Time frame
Secondary end point(s): - Change from Baseline in Fasting Glucose - Change from Baseline in Bolus Insulin Dose - Rate of Total Documented Symptomatic Hypoglycemia - Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590;Timepoint(s) of evaluation of this end point: Week 26	—

Countries

Austria, Germany, Spain

Contacts

Public ContactGennaro De Crescenzo

Eli Lilly Cork LTD

ensayosclinicos@lilly.com003491836 2958

Outcome results

None listed

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