NCT01848990|CompletedPhase 4Results

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)

Halozyme Therapeutics ClinicalTrials.gov

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1 other identifier

Halo-117-403

Study Type

interventional

Target

456

Locations

1 country

Sites

Timeline

RegisteredMay 2013

StartedMar 2013

CompletionSep 2014

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

456

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Mar 2013

Geographic Reach

1 country

39 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

March 1, 2013

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2013

Completed

9 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed

2 months until next milestone

Results Posted

Study results publicly available

October 29, 2014

Completed

Last Updated

November 7, 2018

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

April 29, 2013

Results QC Date

October 23, 2014

Last Update Submit

October 10, 2018

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes MellitusSub Cutaneous Insulin InfusionRapid Acting Analog InsulinHylenexHalozymePhase 4

Outcome Measures

Primary Outcomes (2)

Change From Baseline to 6 Months in Glycosylated Hemoglobin (HbA1c)
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; 6 Months
Change From Baseline to 12 Months in HbA1c
Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; 12 Months

Secondary Outcomes (25)

Rates of Hypoglycemia Events (HE) to Month 6
After Month 1 up to Month 6
Rates of HEs to Month 12
After Month 1 up to Month 12
Rates of Hyperglycemia Events to Month 6
After Month 1 up to Month 6
Rates of Hyperglycemia Events to Month 12
After Month 1 up to Month 12
Mean Glucose Excursions at 6 Months
After Month 1 up to Month 6
+20 more secondary outcomes

Study Arms (3)

Commercial Hylenex Recombinant (Formulation 1)

EXPERIMENTAL

Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous subcutaneous insulin infusion (CSII) (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 units (U) through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).

Drug: Commercial Hylenex® recombinant (hyaluronidase human injection)Drug: Insulin lisproDrug: Insulin aspartDrug: Insulin glulisine

Precommercial Hylenex Recombinant (Formulation 2)

EXPERIMENTAL

Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 units (U) through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).

Drug: Precommercial Hylenex recombinant (hyaluronidase human injection)Drug: Insulin lisproDrug: Insulin aspartDrug: Insulin glulisine

Standard Rapid-Acting Insulin CSII

ACTIVE COMPARATOR

Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.

Drug: Insulin lisproDrug: Insulin aspartDrug: Insulin glulisine

Interventions

Commercial Hylenex® recombinant (hyaluronidase human injection)DRUG

Also known as: Formulation 1, Hylenex, Recombinant human hyaluronidase (rHuPH20)

Commercial Hylenex Recombinant (Formulation 1)

Precommercial Hylenex recombinant (hyaluronidase human injection)DRUG

Also known as: Formulation 2, Hylenex, rHuPH20

Precommercial Hylenex Recombinant (Formulation 2)

Insulin lisproDRUG

Also known as: Humalog, Lispro

Commercial Hylenex Recombinant (Formulation 1)Precommercial Hylenex Recombinant (Formulation 2)Standard Rapid-Acting Insulin CSII

Insulin aspartDRUG

Also known as: Novolog, Aspart

Commercial Hylenex Recombinant (Formulation 1)Precommercial Hylenex Recombinant (Formulation 2)Standard Rapid-Acting Insulin CSII

Insulin glulisineDRUG

Also known as: Apidra, Glulisine

Commercial Hylenex Recombinant (Formulation 1)Precommercial Hylenex Recombinant (Formulation 2)Standard Rapid-Acting Insulin CSII

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female of age 18 years or older with a history of T1DM for at least 12 months
Glycosylated hemoglobin (HbA1c) 6.5% to 9.5% (inclusive) based on central laboratory results
Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL)
Current use of an insulin pump compatible with available tubing for Hylenex recombinant infusion and use of an infusion set compatible with the tubing available or willingness to switch to an infusion set compatible with tubing available for infusion of Hylenex recombinant
Current treatment at the time of screening with insulin \<300 units per day (U/day)
Participants should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug infusions and assessments required in this protocol.

You may not qualify if:

Type 2 diabetes
Known or suspected allergy to any component of any of the study drugs in this study
Severe proliferative retinopathy or maculopathy, and/or gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator
As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including history of stroke, history of arrhythmia, or conduction delays on electrocardiogram \[ECG\]), hepatic, neurological, renal, genitourinary, pulmonary, or hematological systems of such severity as to impede the participant's ability to comply with protocol procedures
History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the participant
As judged by the Investigator, clinically significant findings in routine laboratory data at screening
Hypoglycemic unawareness of such severity as to impede the participant's ability to comply with protocol procedures, as judged by the Investigator.
Current addiction to alcohol or substance abuse as determined by the Investigator.
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, and/or barrier methods). Abstinence alone is not considered an adequate contraceptive measure for the purposes of this study.
Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study

Contact the study team to confirm eligibility.