Phase 1
Completed N=80
A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03166124 ↗
Enrolled (actual)
80
Serious AEs
0.7%
Results posted
Apr 2020
Primary outcomePrimary: Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm — 1430; 1400; 1210; 1170 picomole * hour per Liter (pmol*h/L)
Summary
The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in elderly and younger adults with type 1 diabetes mellitus.
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 to 8 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics: Insulin Lispro Area Under the Concentration Versus Time Curve (AUC) for Each Treatment Arm |
1430; 1400; 1210; 1170 | — |
| SECONDARY Total Amount of Glucose Infused (Gtot) Over Duration of Clamp for Each Treatment Arm |
1140; 1090; 1170; 1150 | — |
Eligibility Criteria
Inclusion Criteria
- Are male or female participants with Type 1 Diabetes Mellitus (T1DM)
- Have a body mass index (BMI) of 18.5 to 30.0 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 T1DM), 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 (NCT03166124). 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.