Status:

COMPLETED

A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus

Lead Sponsor:

Eli Lilly and Company

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes.

Eligibility Criteria

Inclusion

  • 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 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

Exclusion

  • Have type 1 diabetes mellitus or latent autoimmune diabetes
  • Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
  • 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)
  • Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
  • Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m²
  • Have active or untreated cancer
  • Are receiving chronic (\>14 days) systemic glucocorticoid therapy

Key Trial Info

Start Date :

July 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 8 2021

Estimated Enrollment :

278 Patients enrolled

Trial Details

Trial ID

NCT04450394

Start Date

July 1 2020

End Date

October 8 2021

Last Update

November 2 2022

Active Locations (64)

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Page 1 of 16 (64 locations)

1

Syed Research Consultants Llc

Sheffield, Alabama, United States, 35660

2

National Research Institute - Huntington Park

Huntington Park, California, United States, 90255

3

National Research Institute - Wilshire

Los Angeles, California, United States, 90057

4

Catalina Research Institute, LLC

Montclair, California, United States, 91763