A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes

• Status: Completed
• Trial end date: 2021-01-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective 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

Criteria

Inclusion Criteria:

• Participants must have T2D based on the disease diagnostic criteria World Health Organization (WHO) classification.

• Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily.

• Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs).

• Participants must have a HbA1c ≥7.0% and ≤11.0%.

• Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).

Exclusion Criteria:

• Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults.

• Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening.

• Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.

• Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.