A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes

• Status: Completed
• Trial end date: 2019-03-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Insulin; Insulin Glargine; Insulin Lispro; Insulin, Globin Zinc; Insulin, Long-Acting; Metformin; Sodium-Glucose Transporter 2 Inhibitors

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.