Phase 1
Completed N=38
A Study of LY900014 in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03305822 ↗Enrolled (actual)
38
Serious AEs
1.3%
Results posted
May 2020
Primary outcomePrimary: Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm — 1380; 1280 hour times picomol per liter (pmol*h/L)
Summary
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 2 diabetes mellitus. The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).
Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be between 3 and 8 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Area Under the Plasma Concentration Curve Zero to 10 Hours (AUC[0-10) Following Each Treatment Arm |
1380; 1280 | — |
| SECONDARY Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm |
749; 647 | — |
Eligibility Criteria
Inclusion Criteria
- Are male or female participants with Type 2 Diabetes Mellitus (T2DM) 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 T2DM), 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
- Have a history of renal impairment
- Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg vein thrombosis in first-degree relatives
- Have proliferative retinopathy or maculopathy and/or severe neuropathy
Data sourced from ClinicalTrials.gov (NCT03305822). 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.