Phase 1
N=14
A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00979875 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) — 11667.14; 23807.14; 10687.14; 27850.00 minutes*nanomolars (min*nM) — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Recombinant human hyaluronidase PH20 (rHuPH20) (Drug); Insulin lispro (Drug); Insulin glulisine (Drug); Insulin aspart (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Halozyme Therapeutics
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60) |
11667.14; 23807.14; 10687.14; 27850.00; 8065.00; 20778.57 | <0.0001 sig |
| SECONDARY Time to Maximum Serum Insulin Concentration (Tmax) |
80.36; 41.43; 67.50; 41.07; 85.71; 43.57 | <0.0001 sig |
| SECONDARY Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max]) |
21.06; 10.16; 30.69; 18.96; 31.93; 17.98 | — |
| SECONDARY Time to Maximum Glucose Infusion Rate (tGIR[Max]) |
141.93; 113.36; 160.14; 103.57; 158.79; 96.93 | — |
| SECONDARY Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t) |
2.02; 5.29; 0.68; 2.38; 0.56; 2.92 | — |
| SECONDARY Time to Percentage of Total Insulin Exposure |
39.59; 23.39; 46.56; 26.35; 48.42; 26.99 | — |
Summary
This is a single-center, Phase 1, randomized, double-blind, 6-way crossover study to determine insulin pharmacokinetics, insulin glucodynamics, safety, and tolerability of subcutaneously administered dose(s) of insulin lispro + recombinant human hyaluronidase PH20 (rHuPH20), insulin lispro alone, insulin glulisine + rHuPH20, insulin glulisine alone, insulin aspart + rHuPH20, and insulin aspart alone.
Eligibility Criteria
Inclusion Criteria
- Healthy participants between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities).
- Body mass index (BMI) between 18-27 kilograms per meter squared (kg/m^2), inclusive.
- Total body weight >65 kilograms (kg) (143 pounds [lb]) for men and >46 kg (101 lb) for women.
- Decision making capacity and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including adequate venous access.
- Vital signs (blood pressure [BP], pulse rate, body temperature) within normal range or, if out of range, assessed by the Principal Investigator as not clinically significant.
- Fasting blood glucose level 100 milliliters (mL), within 56 days before dosing.
- Participation in a study of any investigational drug or device 30 days before enrollment in this study.
- The participant is unfit for the study in the opinion of the investigator.
- Women who are pregnant or breast-feeding.
Data sourced from ClinicalTrials.gov (NCT00979875). 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.