Phase 2 Completed N=48 Randomized

Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1

Source: ClinicalTrials.gov NCT00883558 ↗

Enrolled (actual)

Serious AEs

3.4%

Results posted

Sep 2014

Primary outcomePrimary: Postprandial Glucose Excursion — 17.23; 14.47 milligrams per deciliter (mg/dL) — p=0.3217

Summary

Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.

Outcome Measures

Outcome	Result	p-value
PRIMARY Postprandial Glucose Excursion	17.23; 14.47	0.3217
SECONDARY Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring	14.58; 13.37	—
SECONDARY Number of Participants With Hypoglycemic Events	45; 43; 2; 0	—

Eligibility Criteria

Inclusion Criteria

Male or female of age 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.
Participants with Type 1 diabetes mellitus (T1DM) (per World Health Organization [WHO] criteria) treated with insulin for ≥24 months.
Participants who use an insulin infusion pump for basal insulin administration must be on the device for at least 90 days prior to screening.
Body mass index (BMI) 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive.
Glycosylated hemoglobin A1c (HbA1c) ≤7.5 % based on central laboratory screening results.
Fasting C-peptide 1.5 milligrams per deciliter [mg/dL] for males or >1.4 mg/dL for females), congestive heart failure required medication treatment, and cardiac disease with New York Heart Association (NYHA) Functional Capacity of III/IV.

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Data sourced from ClinicalTrials.gov (NCT00883558). 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.