Phase 1
Completed N=42
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03465878 ↗Enrolled (actual)
42
Serious AEs
0.6%
Results posted
Jun 2020
Primary outcomePrimary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part — 755; 754; 962; 908 Picomoles*hour/Liter (pmol*h/L) — p=0.9813
Summary
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in participants with type 1 diabetes mellitus.
There are 2 parts to this study. Part A is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by subcutaneous injection. Part B of the study is investigating how the body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion (CSII) pump.
Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 40 days in each part.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) Following Each Treatment Arm for Each Study Part |
755; 754; 962; 908; 987; 975 | 0.9813 |
| SECONDARY Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Versus Time Curve Following Each Treatment Arm for Each Study Part |
384; 492; 577; 651; 372; 351 | — |
Eligibility Criteria
Inclusion Criteria
- Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at least 1 year
- Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)
Exclusion Criteria
- Receiving any oral or injectable medication intended for the treatment of diabetes mellitus other than insulins in the 12 months prior to screening
- More than one episode of severe hypoglycaemia in the last 6 months
- Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease, uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency
- Have obvious clinical signs or symptoms of liver disease
- Have a history of renal impairment
Data sourced from ClinicalTrials.gov (NCT03465878). 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.