Phase 1
Completed N=36
A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov NCT03341312 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr) — 1320; 1240 picomol times hour per Liter
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 will last 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 Zero to Seven Hours (AUC0-7hr) |
1320; 1240 | — |
| SECONDARY Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm |
97.8; 112; 131; 146 | — |
Eligibility Criteria
Inclusion Criteria
- Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m²
- Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0%
- Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L)
- Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn [NPH] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening
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)
- Require daily insulin treatment greater than (>)1.2 units per kilogram per body weight (U/kg/body weight)
Data sourced from ClinicalTrials.gov (NCT03341312). 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.