Phase 4
Completed N=14
A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)
Source: ClinicalTrials.gov NCT03662334 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours |
— | — |
| PRIMARY Part 2: Time to Reduction in Plasma Glucose by 80 Milligrams Per Deciliter (mg/dL) Following CSII Bolus |
5.58; 5.23; 4.63; 5.32 | — |
| PRIMARY Part 3: Time to Achieve Plasma Glucose >90 mg/dL After Release of Hypoglycemic CSII Clamp |
— | — |
| SECONDARY Part 1: Time-action Profile, Assessed by GIR in Euglycemic Participants |
— | — |
| SECONDARY Part 1: Mean Maximum Concentration (Cmax) |
— | — |
| SECONDARY Part 1: Time to Achieve Maximum Concentration (Tmax) |
— | — |
| SECONDARY Part 1: Early Time to 50% Maximum Serum Insulin Concentration (t50%) Max |
— | — |
| SECONDARY Part 1: Time to 50% of Total AUC (AUC0-last) |
— | — |
| SECONDARY Part 1: Fractional and Absolute AUC0-1hr |
— | — |
| SECONDARY Part 1: Fractional and Absolute AUC2hr-end |
— | — |
| SECONDARY Part 1: Area Under the Curve From Time Zero to the Last Measureable Concentration (AUC0-last) |
— | — |
| SECONDARY Part 1: Mean Residence Time (MRT) |
— | — |
| SECONDARY Part 2: Plasma Glucose Concentration Over Time |
299; 341; 350; 445 | — |
| SECONDARY Part 2: Insulin Analog Serum Concentration as a Function of Time Following Bolus Insulin Infusion |
1341.8; 805.1; 688.5; 1092.6 | — |
| SECONDARY Part 3: Plasma Glucose Concentration Over Time |
— | — |
| SECONDARY Part 3: Insulin Analog Serum Concentration as a Function of Time Following Termination of Insulin Infusion |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or female participants between the ages 18 and 65 years, inclusive.
- Females of child-bearing potential must agree to use a standard and effective means of birth control for the duration of the study. Adequate contraceptive measures include oral or injectable contraceptives, sterilization, intra-uterine device (IUD), barrier methods, or abstinence.
- Participants with type 1 diabetes mellitus treated with insulin (multiple daily injections or continuous subcutaneous insulin infusion [CSII]) diagnosed ≥ 12 months prior to enrollment
- Body mass index (BMI) 18.0 to 32.0 kilograms per meters squared (kg/m^2)
- HbA1c (glycated hemoglobin A1c) ≤ 10% based on local laboratory results
- Fasting C-peptide 500 mL) within the previous 8 weeks (56 days) prior to Day -1 of Treatment Period 1
- Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, IUD, oral or injectable contraceptives, or barrier methods)
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
- Participation in any other clinical trial and receipt of any investigational drug within 4 weeks of Day -1 of Treatment Period 1
- Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data
- Positive for human immunodeficiency virus (HIV), Hepatitis C or Hepatitis B
- Tobacco and nicotine use within 3 months prior to Day 1 of Treatment Period 1 or use during the study
Data sourced from ClinicalTrials.gov (NCT03662334). 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.