A Study of Continuous Subcutaneous Insulin Infusion (CSII) Pump Function in Subjects With Type 1 Diabetes With Recombinant Human Hyaluronidase (rHuPH20)

NCT03662334 | Completed Phase 4 Results

• 1 other identifier: HALO-117-406
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine if Hylenex recombinant leads to changes in the insulin time-action profiles and glucose responses when preadministered in the setting of continuous subcutaneous insulin infusion (CSII) compared to CSII without Hylenex recombinant (sham injection).

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes; Type 1 Diabetes Mellitus; Type 1 Diabetes; T1DM; Continuous Subcutaneous Insulin Infusion (CSII); CSII; Insulin pump; Insulin; rHuPH20; Hylenex; recombinant human hyaluronidase (rHuPH20); Recombinant hyaluronidase

Outcome Measures

Primary Outcomes (3)

• Part 1: Area Under the Curve (AUC) of Glucose Infusion Rate (GIR) From 0-6 Hours

  0-6 hours

• Part 2: Time to Reduction in Plasma Glucose by 80 Milligrams Per Deciliter (mg/dL) Following CSII Bolus

  Time to reduction is reported as the maximum time it took for any participant receiving each treatment sequence to achieve a reduction in plasma glucose by 80 mg/dL. During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 mg/dL, even after adjusting several operational parameters. The study was stopped early, prior to enrolling the planned 24 participants for Part 2. Thus, analysis for this endpoint was not conducted. Raw data (as a maximum) are reported.

  0-10 hours

• Part 3: Time to Achieve Plasma Glucose >90 mg/dL After Release of Hypoglycemic CSII Clamp

  0-12 hours

Secondary Outcomes (13)

• Part 1: Time-action Profile, Assessed by GIR in Euglycemic Participants

  up to approximately 10 hours

• Part 1: Mean Maximum Concentration (Cmax)

  up to approximately 22 hours

• Part 1: Time to Achieve Maximum Concentration (Tmax)

  up to approximately 22 hours

• Part 1: Early Time to 50% Maximum Serum Insulin Concentration (t50%) Max

  up to approximately 22 hours

• Part 1: Time to 50% of Total AUC (AUC0-last)

  up to approximately 22 hours

Study Arms (2)

Hylenex recombinant

EXPERIMENTAL

Comparing the preadministration of Hylenex recombinant in the setting of continuous subcutaneous insulin infusion (CSII).

Drug: Rapid Acting insulin with pre-treatment of rHuPH20

Sham Injection

SHAM COMPARATOR

Comparing the preadministration of a sham injection in the setting of CSII.

Device: Sham injection

Interventions

Rapid Acting insulin with pre-treatment of rHuPH20 DRUG

Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.

Also known as: Humalog, Hylenex

Hylenex recombinant

Sham injection DEVICE

A sham injection will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.

Also known as: placebo

Sham Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants between the ages 18 and 65 years, inclusive.
• Females of child-bearing potential must agree to use a standard and effective means of birth control for the duration of the study. Adequate contraceptive measures include oral or injectable contraceptives, sterilization, intra-uterine device (IUD), barrier methods, or abstinence.
• Participants with type 1 diabetes mellitus treated with insulin (multiple daily injections or continuous subcutaneous insulin infusion \[CSII\]) diagnosed ≥ 12 months prior to enrollment
• Body mass index (BMI) 18.0 to 32.0 kilograms per meters squared (kg/m\^2)
• HbA1c (glycated hemoglobin A1c) ≤ 10% based on local laboratory results
• Fasting C-peptide \< 0.6 nanograms per milliliter (ng/mL)
• Current treatment with insulin \<1.2 Units per kg per day (U/kg/day)
• Participant should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol

You may not qualify if:

• Inability to comply with study requirements as judged by the Investigator
• Known or suspected allergy to any component of any of the study drugs in this trial
• A participant who has proliferative retinopathy or maculopathy, severe gastroparesis, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator
• As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on electrocardiogram), hepatic, neurological, renal, genitourinary, or hematological systems
• As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥ 100 millimeters of mercury \[mmHg\] and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position)
• History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the participant
• Use of drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, or drugs not permitted according to Hylenex recombinant package insert
• Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator
• Current addiction to alcohol or substances of abuse as determined by the Investigator
• Blood donation (\> 500 mL) within the previous 8 weeks (56 days) prior to Day -1 of Treatment Period 1
• Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, IUD, oral or injectable contraceptives, or barrier methods)
• Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation in this study
• Participation in any other clinical trial and receipt of any investigational drug within 4 weeks of Day -1 of Treatment Period 1
• Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data
• Positive for human immunodeficiency virus (HIV), Hepatitis C or Hepatitis B

Sponsors & Collaborators

• Halozyme Therapeutics: lead

Study Sites (1)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

Related Links

• Halozyme Therapeutics

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Insulin Resistance

Interventions

Insulin, Short-Acting; Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

During the course of the study, it became difficult to establish a stable hyperglycemic plateau with a target glucose level of 220 milligrams per deciliter. The study was stopped early, prior to enrolling the planned 24 participants for Part 2.

Results Point of Contact

• Title: Dimitrios Chondros, M.D., Chief Medical Officer
• Organization: Halozyme Therapeutics

dchondros@halozyme.com

858-794-8889

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: September 7, 2018
• Study Start: October 3, 2013
• Primary Completion: February 27, 2014
• Study Completion: February 27, 2014
• Last Updated: February 1, 2019
• Results First Posted: February 1, 2019

Record last verified: 2019-01

Locations

US (1)