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Completed

NCT Number: NCT06169982

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3209590

Drug

Administered SC

Primary outcomes

  1. Pharmacokinetics (PK): Area under the concentration curve during one dosing interval at steady state (AUCss) of LY3209590

    Time frame: One dosing interval at steady state from 0 to 168 hours after last dose

    PK: AUCss of LY3209590

Secondary outcomes

  1. PK: Total amount of glucose infused during one dosing interval at steady state (Gtot,SS) of LY3209590

    Time frame: One dosing interval at steady state from 0 to 168 hours after last dose

    PK: Gtot,SS of LY3209590

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2023
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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