A Study of LY900014 in Participants With Type 2 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY900014; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03305822

16640

I8B-MC-ITRU (Other Identifier)

2017-001305-33 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 2 diabetes mellitus. The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 and 8 weeks.

Enrollment: 38 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are male or female participants with Type 2 Diabetes Mellitus (T2DM) for at least 1 year
• Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)
• Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)
• Have had no episodes of severe hypoglycaemia in the last 6 months

Exclusion criteria

• Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from T2DM), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
• Have a history of renal impairment
• Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
• Have proliferative retinopathy or maculopathy and/or severe neuropathy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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38 participants in 2 patient groups

LY900014

Experimental group

Description:

Single, subcutaneous (SC) dose of 15 Units (U) LY900014 in one of two study periods

Treatment:

Drug: LY900014

Insulin Lispro (Humalog)

Active Comparator group

Description:

Single SC dose of 15 U insulin lispro (Humalog) in one of two study periods

Treatment:

Drug: Insulin Lispro