Phase 1
Completed N=45
Randomized, Double-blind, Crossover, Pharmacokinetic (PK) and Glucodynamic (GD) Study of Continuous Subcutaneous Insulin Infusion (CSII) in Participants With Type 1 Diabetes Mellitus (T1DM)
Source: ClinicalTrials.gov NCT01275131 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcomePrimary: Early Insulin Exposure (%AUC[0-60]), Stage 1 — 20.99; 34.94; 32.83; 50.97 Percentage of AUC(0-360) — p=0.0009
Summary
The purpose of this study is to determine if recombinant human hyaluronidase PH20 (rHuPH20) will change the exposure and action of approved insulin analogs when given by continuous subcutaneous insulin infusion (CSII) in participants with Type 1 diabetes mellitus (T1DM).
This study is divided into Stage 1, 2, and 3. Stage 3 was started chronologically before Stage 2 and, prior to performing Stage 2, the Sponsor made the decision to terminate Stage 2. Stage 2 was not initiated due to a strategic business decision and termination was not based on safety or efficacy concerns. No participants were enrolled in Stage 2.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Early Insulin Exposure (%AUC[0-60]), Stage 1 |
20.99; 34.94; 32.83; 50.97 | 0.0009 sig |
| PRIMARY Early Exposure to Insulin (%AUC[0-60]), Stage 3 |
15.70; 32.11; 22.29; 36.39; 27.31; 32.64 | <0.0001 sig |
| SECONDARY Maximum Glucose Infusion Rate (GIRmax), Stage 1 |
13.37; 12.51; 11.88; 11.52 | — |
| SECONDARY Maximum Glucose Infusion Rate (GIRmax), Stage 3 |
9.58; 12.63; 10.07; 12.4; 9.97; 10.76 | — |
| SECONDARY Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 1 |
115.38; 102.38; 92.50; 84.31 | — |
| SECONDARY Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 3 |
127.65; 78.53; 135.24; 79.47; 117.76; 79.53 | — |
| SECONDARY Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 1 |
46.50; 34.88; 162.19; 158.06; 35.19; 39.75 | — |
| SECONDARY Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 3 |
58.47; 31.06; 144.18; 98.71; 32.59; 31.53 | — |
| SECONDARY Time to 50% Total Glucose Infused (50%Gtot), Stage 1 |
156.13; 134.94; 137.38; 115.25 | — |
| SECONDARY Time to 50% Total Glucose Infused (50%Gtot), Stage 3 |
174.59; 124.18; 154.06; 120.00; 146.59; 130.18 | — |
| SECONDARY Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 1 |
1978.08; 1977.02; 1598.40; 1324.31 | — |
| SECONDARY Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 3 |
1197.60; 1509.38; 1368.81; 1405.75; 1289.22; 1369.97 | — |
| SECONDARY Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 1 |
163.63; 146.51; 147.50; 132.60 | — |
| SECONDARY Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 3 |
180.39; 138.59; 164.65; 135.71; 156.14; 145.81 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female aged 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study.
- Non-smoking participants with Type 1 diabetes mellitus (T1DM) treated with insulin for greater than or equal to 12 months. Non-smoking means abstinence from cigarettes and cigars for 3 months and negative cotinine screening tests.
- Body mass index (BMI) 18.0 to 35.0 kilograms per meter squared (kg/m^2), inclusive.
- Glycosylated hemoglobin A1c (HbA1c) ≤10 % based on local laboratory results.
- Fasting C-peptide 500 milliliters [mL]) within the previous 8 weeks of Screening. This applies both to new participants and to participants who have participated in Stage 1 and who wish to continue in Stage 2.
- Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives, or barrier methods).
- Symptomatic gastroparesis.
- Receipt of any investigational drug within 4 weeks of Stage 1 or Stage 2.
Data sourced from ClinicalTrials.gov (NCT01275131). 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.