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

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Insulin Lispro; Drug: LY900014; Drug: Insulin Glargine; Drug: Insulin Degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT03952143

16830

I8B-FH-ITSE (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 628 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

628 participants in 2 patient groups

LY900014

Experimental group

Description:

Participants received 100 units per milliliter (U/mL) LY900014 subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.

Treatment:

Drug: Insulin Glargine

Drug: Insulin Degludec

Drug: LY900014

Insulin Lispro

Active Comparator group

Description:

Participants received 100 U/mL insulin lispro (Humalog) given SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily.

Treatment:

Drug: Insulin Glargine

Drug: Insulin Degludec

Drug: Insulin Lispro