Who is sponsoring NCT01194258?

NCT01194258 is sponsored by Halozyme Therapeutics.

What condition does NCT01194258 study?

NCT01194258 studies Diabetes Mellitus, Type II.

What drugs are being tested in NCT01194258?

Interventions: Insulin lispro, Insulin aspart, Recombinant human hyaluronidase PH20, Insulin glulisine, Insulin glargine.

What is the status of NCT01194258?

NCT01194258 is currently COMPLETED.

Last reviewed 2014-08-01 · How we verify

A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 2 Diabetes

NCT01194258 Phase 2 COMPLETED Results posted

The purpose of the study was to compare Humalog (insulin lispro)-recombinant human hyaluronidase PH20 (rHuPH20) or Novolog (insulin aspart)-rHuPH20 to insulin lispro for the treatment of Type 2 diabetes mellitus (T2DM) in basal-bolus therapy.

Details

Lead sponsor	Halozyme Therapeutics
Phase	Phase 2
Status	COMPLETED
Enrolment	132
Start date	2010-08
Completion	2011-08

Conditions

Diabetes Mellitus, Type II

Interventions

Insulin lispro
Insulin aspart
Recombinant human hyaluronidase PH20
Insulin glulisine
Insulin glargine

Primary outcomes

Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period — Baseline, Week 12 and Week 24
Change in glycosylated hemoglobin A1C (HbA1C) from baseline (Week 0) to end of treatment period (Week 12 and Week 24) is presented. Data are presented by combined treatment group (Lispro-recombinant human hyaluronidase PH20 (PH20) + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin lispro from both groups). Least squares (LS) means were calculated from linear contrasts of mixed effects linear models with treatment (Lispro, Aspart), PH20 (yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.

Countries

United States