Phase 1
Completed N=80
A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03449433 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm — 786; 756; 938; 928 picomols times hour per Liter
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Insulin Lispro or Insulin Aspart Area Under the Concentration Curve From Zero to Seven Hours (AUC 0-7h) Following Administration of Each Study Arm |
786; 756; 938; 928 | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline Area Under the Concentration Curve of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) |
81.5; 141; 157; 101; 44.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03449433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.