Phase 1
Completed N=31
A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03407118 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to 10 Hours (AUC 0-10h) Following Administration of Each Treatment Arm — 1930; 1980 picomols times hour per Liter
Summary
This study will compare LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog). Both drugs will be given by injection under the skin of the abdomen. This study will be conducted in participants with type 1 diabetes to investigate how quickly and how much LY900014 is absorbed and the effect of LY900014 on blood sugar levels in comparison with insulin lispro. The study will last about 3 to 6 weeks for each participant, not including screening.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to 10 Hours (AUC 0-10h) Following Administration of Each Treatment Arm |
1930; 1980 | — |
| SECONDARY Glucodynamics (GD): Total Amount of Glucose Infused (Gtot) Over Duration of Clamp Following Administration of Each Treatment Arm |
1190; 1250 | — |
Eligibility Criteria
Inclusion Criteria
- Are Japanese male or female participant with a diagnosis of T1DM, based on the World Health Organization classification, for at least 1 year prior to screening
- Have a body mass index (BMI) of 18.5 to 30.0 kilograms per square meter (kg/m²)
- Have a glycated hemoglobin 1.42 milligrams per deciliter [mg/dL]) (male) or ≥111 μmol/L (>1.25 mg/dL) (female)
- Have a history of deep vein thrombosis of the leg, or repeated episodes of deep leg vein thrombosis in first-degree relatives (parents, siblings, or children), as determined by the investigator
- Have proliferative retinopathy or maculopathy and/or severe neuropathy; in particular, autonomic neuropathy, as determined by the investigator based on a recent ( 1.5 units per kilogram (U/kg)
Data sourced from ClinicalTrials.gov (NCT03407118). 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.