A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: LY900014; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03166124

16637

I8B-MC-ITRR (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.

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 to 8 weeks.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are male or female participants with Type 1 Diabetes Mellitus (T1DM)
• Have a body mass index (BMI) of 18.5 to 30.0 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 T1DM), 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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80 participants in 4 patient groups

Elderly Adults LY900014

Experimental group

Description:

Single, subcutaneous (SC) 15-U dose of LY900014 in the elderly adult group.

Treatment:

Drug: LY900014

Elderly Adults Insulin Lispro

Active Comparator group

Description:

Single, SC 15-U dose of insulin lispro (Humalog) in in the elderly adult group.

Treatment:

Drug: Insulin Lispro

Younger Adults LY900014

Experimental group

Description:

Single, SC 15-U dose of LY900014 in the younger adult group.

Treatment:

Drug: LY900014

Younger Adults Insulin Lispro

Active Comparator group

Description:

Single, SC 15-U dose of insulin lispro (Humalog) in the younger adult group.

Treatment:

Drug: Insulin Lispro