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A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus

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Lilly

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Insulin Aspart
Drug: LY900014
Drug: Insulin Lispro

Study type

Interventional

Funder types

Industry

Identifiers

NCT03449433
I8B-MC-ITSL (Other Identifier)
16911
2017-003459-47 (EudraCT Number)

Details and patient eligibility

About

Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. The study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. A test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. The safety and tolerability of LY900014 will also be assessed. Screening is required within 14 days prior to the lead in. For each participant, the study will last up to 91 days.

Enrollment

80 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Are male or female participants with Type 1 Diabetes Mellitus (T1DM) 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 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

80 participants in 5 patient groups

LY900014
Experimental group
Description:
T1DM participants received a single, individualized, subcutaneous (SC) dose of LY900014.
Treatment:
Drug: LY900014
Insulin Lispro (Humalog®)
Active Comparator group
Description:
T1DM participants received a single, individualized, SC dose of insulin lispro.
Treatment:
Drug: Insulin Lispro
Insulin Aspart (NovoRapid®)
Active Comparator group
Description:
T1DM participants received a single, individualized, SC dose of insulin aspart.
Treatment:
Drug: Insulin Aspart
Drug: Insulin Aspart
Insulin Aspart (Fiasp®)
Active Comparator group
Description:
T1DM participants received a single, individualized, SC dose of insulin aspart.
Treatment:
Drug: Insulin Aspart
Drug: Insulin Aspart
Healthy Participants
No Intervention group
Description:
Healthy participants who received no study drug.

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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