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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase 1, Open-Label, Multiple-Dose Study to Investigate Steady-State Pharmacokinetics and Pharmacodynamics During a Euglycemic Clamp of LY3209590 in Participants With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06169982
• Other study ID #: 18811
• Secondary ID: I8H-MC-BDDG2023-
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 7, 2023
• Est. completion date: July 20, 2024

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: July 20, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3209590
Administered SC

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung	Neuss	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area under the concentration curve during one dosing interval at steady state (AUCss) of LY3209590	PK: AUCss of LY3209590	One dosing interval at steady state from 0 to 168 hours after last dose
Secondary	PK: Total amount of glucose infused during one dosing interval at steady state (Gtot,SS) of LY3209590	PK: Gtot,SS of LY3209590	One dosing interval at steady state from 0 to 168 hours after last dose