Phase 1
Completed N=38
A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT02111083 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
May 2015
Primary outcomePrimary: Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast) — 2200; 2230 picomole*hour/liter (pmol*h/L)
Summary
The study involves 4 injections of insulin lispro and its purpose is to:
* Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
* Compare how the 2 formulations of insulin lispro affect blood sugar level.
* Determine the safety of each insulin lispro formulations and any side effects that might be associated with them when given to healthy participants. The study is expected to last up to approximately 9 weeks for each participant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Parameter: Area Under the Serum Insulin Concentration Versus Time Curve From Zero to Time of Return to Baseline (AUC0-tlast) |
2200; 2230 | — |
| PRIMARY Pharmacokinetic Parameter: Maximum Serum Insulin Concentration (Cmax) |
744; 851 | — |
| PRIMARY Pharmacokinetic Parameter: Area Under the Curve(AUC) |
2330; 2360 | — |
| SECONDARY Pharmacokinetic Parameter: Time of Maximum Observed Serum Concentration (Tmax) |
1; 1 | — |
| SECONDARY Pharmacodynamic Parameter: Total Amount of Glucose Infused (Gtot) |
120; 120 | — |
| SECONDARY Pharmacodynamic Parameter: Maximum Glucose Infusion Rate (Rmax) |
503; 526 | — |
| SECONDARY Pharmacodynamic Parameter: Time of Maximum Glucose Infusion Rate (tRmax) |
2.71; 2.32 | — |
Eligibility Criteria
Inclusion Criteria
- Are healthy males or females
- Body mass index (BMI) between 18.5 and 29.9 kilogram 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 (fasting blood glucose [FBG], plasma) >6 millimoles per liter (mmol/L) at screening
- Have positive hepatitis B surface antigen.
Data sourced from ClinicalTrials.gov (NCT02111083). 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.