Phase 1
N=30
A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT02703350 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A) — 719; 783 picomole*hour per liter (pmol*h/L)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY900014 (Drug); Insulin Lispro (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part A) |
719; 783 | — |
| PRIMARY Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) (Part B) |
751; 780; 718; 771 | — |
| SECONDARY Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part A) |
495; 537 | — |
| SECONDARY Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) (Part B) |
533; 404; 547; 411 | — |
Summary
The study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes LY900014 and the effect of LY900014 on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.
Eligibility Criteria
Inclusion Criteria
- Are male or female participants with Type 1 Diabetes Mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
- Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
- Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results acceptable for the study
- Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party)
- Have venous access sufficient to allow for blood sampling
- Have provided written consent and are willing to follow study procedures and commit to the study duration
Exclusion Criteria
- Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have previously completed or withdrawn from this study
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study
- Had blood loss of more than 500 milliliters (mL) within the last month
- Are treated with a continuous subcutaneous insulin infusion (insulin pump)
Data sourced from ClinicalTrials.gov (NCT02703350). 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.