Phase 1
Completed N=36
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03341299 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) — 970; 968 picomoles times hour per Liter — p=0.7734
Summary
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and there will be approximately 12 weeks from screening to final study follow up.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) |
970; 968 | 0.7734 |
| SECONDARY Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve |
207; 264; 227; 327 | 0.7190 |
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 kilogram per meter square (kg/m²) to 35.0 kg/m²
- Have a glycated hemoglobin (HbA1c) ≤9.0% at screening
- Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day)
Exclusion Criteria
- Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
- Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening.
- Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator.
- Are treated with a CSII (insulin pump)
Data sourced from ClinicalTrials.gov (NCT03341299). 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.