A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY900014; Insulin Lispro; Insulin Glargine; Insulin Degludec; Metformin; SGLT2 inhibitor
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC; Administered orally.; Administered orally.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Lispro; Sodium-Glucose Transporter 2 Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 933.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare LY900014 to insulin lispro, both in combination with
      insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed (clinically) with T2D, based on the World Health Organization
             (WHO) classification for at least 1 year prior to screening.

          -  Have been treated for at least 90 days prior to screening with:

               -  Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300,
                  insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn
                  [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin
                  (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular
                  insulin) Or

               -  Premixed analog or human insulin regimens with any basal and bolus insulin
                  combination injected at least twice daily

          -  Participants may be treated with up to 3 of the following oral antihyperglycemic
             medications (OAMs) in accordance with local regulations:

               -  Metformin

               -  Dipeptidyl peptidase-4 (DPP-4) inhibitor

               -  Sodium glucose cotransporter 2 (SGLT2) inhibitor

               -  Sulfonylurea

               -  Meglitinide

               -  Alpha-glucoside inhibitor

          -  Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at
             the time of screening.

          -  Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.

        Exclusion Criteria:

          -  Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune
             Diabetes in Adults.

          -  Have hypoglycemia unawareness as judged by the investigator.

          -  Have had any episode of severe hypoglycemia within the 6 months prior to screening.

          -  Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar
             state within the 6 months prior to screening.

          -  Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or
             pramlintide within 90 days prior to screening.