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

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).

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Type 2 Diabetes
What the trial is testing?
Insulin Degludec, Insulin Glargine, Insulin Lispro, LY900014
Could I receive a Placebo?
No
Enrollment Goal
628
Trial Dates
May 27, 2019 - Jan 20, 2021
How long will I be in the trial?
The study will last about 39 weeks and may include up to 19 visits.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • 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)

Participants Must Not:

  • 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

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