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

Overview

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

Full Title of Study: “A Phase 2, Parallel, Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Insulin-Naïve Patients With Type 2 Diabetes Mellitus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 16, 2021

Interventions

  • Drug: LY3209590
    • Administered SC
  • Drug: Insulin Degludec
    • Administered SC

Arms, Groups and Cohorts

  • Experimental: LY3209590 Algorithm 1
    • LY3209590 administered subcutaneously (SC).
  • Experimental: LY3209590 Algorithm 2
    • LY3209590 administered SC.
  • Active Comparator: Insulin Degludec
    • Insulin degludec administered SC.

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline in Hemoglobin A1c (HbA1c)
    • Time Frame: Baseline, Week 26
    • Change from Baseline in HbA1c

Secondary Measures

  • Change from Baseline in Fasting Glucose
    • Time Frame: Baseline, Week 26
    • Change from Baseline in Fasting Glucose
  • Rate of Total Documented Symptomatic Hypoglycemia
    • Time Frame: Baseline through Week 26
    • Rate of Total Documented Symptomatic Hypoglycemia
  • Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
    • Time Frame: Baseline through Week 26
    • PK: AUC of LY3209590

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Criteria

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5hours, EST), Study Director, Eli Lilly and Company
  • Overall Contact(s)
    • There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, clinicaltrials.gov@lilly.com

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