A Study of LY3209590 in Participants With Type 2 Diabetes

A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients with Type 2 Diabetes Mellitus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003339-53-PL

Enrollment

375

Registered

2020-06-03

Start date

2020-09-15

Completion date

Unknown

Last updated

2021-12-06

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

Conditions

Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II 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 type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with a stable dose of metformin in combination with a stable dose of a Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a Sodium-glucose co-transporter-2 (SGLT2) inhibitor) for at least 3 months prior to screening • Participants must have a HbA1c value of 7.0% to 9.5%, inclusive. • Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m²), inclusive. 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 263 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 112

Exclusion criteria

Exclusion criteria: • Participants must not have type 1 diabetes mellitus or latent autoimmune diabetes. • 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 an 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 T2DM;Secondary Objective: - To investigate 2 dosing algorithms on the safety of LY3209590 compared with insulin degludec in study participants with T2DM - To characterize the PK of LY3209590 and potential intrinsic and extrinsic factors in study participants with T2DM;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 T2DM;Secondary Objective: - To investigate 2 dosing algorithms on the safety of LY3209590 compared with insulin degludec in study participants with T2DM - To characterize the PK of LY3209590 and potential intrinsic and extrinsic factors in study participants with T2DM;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 - 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

Germany, Poland

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

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