Phase 1
Completed N=38
Bioequivalence of Two Lispro Formulations
Healthy Volunteers
Source: ClinicalTrials.gov NCT01133392 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcomePrimary: Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast] — 1920; 1940 picomole*hour/liter (pmol*h/L)
Summary
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Time Zero to the Last Time Point With a Measurable Concentration [AUC0-tlast] |
1920; 1940 | — |
| SECONDARY Pharmacokinetic Parameter: Maximum Serum Insulin Concentration [Cmax] |
819; 887 | — |
| SECONDARY Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax) |
544; 539 | — |
| SECONDARY Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax) |
2.11; 2.00 | — |
| SECONDARY Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot) |
125; 123 | — |
Eligibility Criteria
Inclusion Criteria
- Are healthy males or females.
- Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m^2)
- Are nonsmokers.
- Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.
Exclusion Criteria
- History of first-degree relatives known to have diabetes mellitus.
- Evidence of significant active neuropsychiatric disease.
- Evidence of an acute infection with fever or infectious disease.
- Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
- Have used systemic glucocorticoids within 3 months prior to entry into the study.
- Have donated blood of 1 unit or more within the last 3 months prior to study entry.
- Excessive alcohol intake
- Have a fasting venous blood glucose (FBG, plasma) >6 millimoles/liter (mmol/L) at screening.
- Have positive hepatitis B surface antigen.
Data sourced from ClinicalTrials.gov (NCT01133392). 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.