NCT01848990

CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)

CONtinuous Subcutaneous Insulin Infusion STudy ENrolling Type 1 (CONSISTENT 1): Evaluation of Metabolic Outcomes and Safety of Hylenex Recombinant (Hyaluronidase Human Injection) Used as a Preadministration Infusion Site Treatment in Subjects With Type 1 Diabetes (T1DM) Using Continuous Subcutaneous Insulin Infusion (CSII)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 456 (actual)
• Sponsor: Halozyme Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to compare the difference in glycosylated hemoglobin (HbA1c) from baseline to Month 6 using Hylenex recombinant preadministration in continuous subcutaneous insulin infusion (CSII) versus standard CSII and to evaluate the safety of Hylenex recombinant preadministration, including local tolerability, adverse events, and hypo- and hyperglycemia rates.

Detailed description

This Phase 4 study is designed to demonstrate noninferiority of pretreatment with Hylenex recombinant in the CSII setting to rapid-acting analog insulin alone with respect to glycemic control as assessed by changes in HbA1c in participants with Type 1 diabetes mellitus. Total duration of study treatment is 24 months. However, according to the study design, the primary outcome measure is to be assessed at 6 months and an interim analysis is to be completed at 6 months for the secondary outcome measures and adverse events. Therefore, data reported in this clinical trials record is for the 6-month interim analysis.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Commercial Hylenex® recombinant (hyaluronidase human injection)
DRUG	Precommercial Hylenex recombinant (hyaluronidase human injection)
DRUG	Insulin lispro
DRUG	Insulin aspart
DRUG	Insulin glulisine

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-02-01
• Completion: 2014-09-01
• First posted: 2013-05-08
• Last updated: 2018-11-07
• Results posted: 2014-10-29

Locations

39 sites across 1 country: United States