A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes

NCT ID: NCT06169982

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-07
• Study Completion Date: 2024-07-18

Brief Summary

The purpose of this study is to measure the activity and insulin time action of LY3209590 at steady state in participants with type 2 diabetes mellitus. The total study duration is approximately 182 days.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

LY3209590

LY3209590 administered subcutaneously (SC)

Group Type: EXPERIMENTAL

LY3209590

Intervention Type: DRUG

Administered SC

Interventions

LY3209590

Administered SC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants with Type 2 Diabetes (T2DM).
• Participants who are insulin naive or receiving basal insulin [NPH (neutral protamine Hagedorn) once or twice daily, once-daily insulin glargine U100 or U300, once-daily insulin degludec, or insulin detemir once or twice daily] for fewer than 5 years prior to screening.
• Have glycated hemoglobin (HbA1c) of ≥7.0 percent (%) to ≤9.5%, HbA1c of ≥6.5% to ≤9.5% for participants on treatment with sulfonylureas and/or Sodium-Glucose Transport Protein 2 inhibitors who require washout.
• Have a body mass index between 27 and 40 kilograms per meter square.
• Male or female participants who are willing to comply with the contraception requirements consistent with local regulations.
• Be willing to allow blood sample collection, reliable and to be available for the duration of the study as required for the study protocol.

Exclusion Criteria

• Have known or suspected allergic reactions to study drugs, related compounds, excipients, and devices used in the study.
• Have a specific type of diabetes other than T2DM.
• Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
• Participants with a history of kidney complications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

I8H-MC-BDDG

Identifier Type: OTHER

Identifier Source: secondary_id

2023-508008-39-00

Identifier Type: OTHER

Identifier Source: secondary_id

18811

Identifier Type: -

Identifier Source: org_study_id