A Study of LY900014 in Participants With Type 1 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Lispro; Drug: LY900014

Study type: Interventional

Funder types: Industry

Identifiers

NCT03465878

2017-003220-78 (EudraCT Number)

I8B-MC-ITSA (Other Identifier)

16695

Details and patient eligibility

About

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

There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.

Enrollment: 56 patients

Sex: All

Ages: 6 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
• Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

Exclusion criteria

• Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
• More than one episode of severe hypoglycaemia in the last 6 months
• Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
• Have obvious clinical signs or symptoms of liver disease
• Have a history of renal impairment

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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56 participants in 4 patient groups

LY900014-Part A

Experimental group

Description:

Participants received single 0.2 U/kg of body weight subcutaneous (SC) bolus injection of 100 U/mL LY900014.

Treatment:

Drug: LY900014

Humalog (Insulin Lispro)-Part A

Active Comparator group

Description:

Participants received single 0.2 U/kg of body weight SC bolus injection of 100 U/mL of Humalog.

Treatment:

Drug: Insulin Lispro

LY900014-Part B

Experimental group

Description:

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL LY900014 delivered using the continuous subcutaneous insulin infusion (CSII) pump.

Treatment:

Drug: LY900014

Humalog (Insulin Lispro)-Part B

Active Comparator group

Description:

Participants received single 0.2 U/kg of body weight SC bolus infusion of 100 U/mL Humalog delivered using the CSII pump.

Treatment:

Drug: Insulin Lispro