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Clinical Trials List

Protocol NumberI8H-MC-BDCY
NCT Number(ClinicalTrials.gov Identfier)NCT05463744
Completed

2022-09-16 - 2026-12-31

Phase III

Recruiting6

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chii-Min Hwu Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃建寧 Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 杜思德 Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-TE LEE Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃偉輔 Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Horng-Yih Ou Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Type 1 Diabetes

Objectives

Efficacy and safety of LY3209590 compared with insulin degludec in participants with type 1 diabetes receiving multiple daily injection therapy

Test Drug

LY3209590/Basal Insulin - Fc (BIF)

Active Ingredient

LY3209590

Dosage Form

Solution for injection

Dosage

500 units/ml

Endpoints

- Demonstrated non-inferiority of LY3209590 to insulin degludec in adults with T1D

Inclution Criteria

Inclusion Criteria:

Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening
Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening
Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.
Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Exclusion Criteria

Exclusion Criteria:

Have a diagnosis of type 2 diabetes, latent autoimmune diabetes, or specific types of diabetes other than type 1 diabetes
Have a history of more than 1 episode of severe hypoglycemia, within the 6 months prior to screening.
Have a history of more than 1 episode of diabetic ketoacidosis or hyperosmolar state or coma requiring hospitalization within the 6 months prior to screening.

The Estimated Number of Participants

  • Taiwan

    33 participants

  • Global

    670 participants