Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase

NCT ID: NCT01526733

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-09-30

Brief Summary

The purpose of this study is to evaluate consistency of accelerated insulin absorption and onset-of-action and shortened duration of action for bolus insulin infusions after pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 [rHuPH20]) injection at the time of infusion set insertion compared to sham injection.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Insulin (Aspart or Lispro)-Sham

In Phase I or Phase II of the study, participants received 0.15 units per kilogram (U/kg) insulin (either insulin aspart or insulin lispro) as a continuous subcutaneous insulin infusion (CSII) for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.

Each Phase was separated by a washout period of 5 to 21 days.

Group Type: SHAM_COMPARATOR

Sham Injection

Intervention Type: DRUG

Insulin aspart

Intervention Type: DRUG

Insulin lispro

Intervention Type: DRUG

Insulin (Aspart or Lispro)-rHuPH20

In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of recombinant human hyaluronidase (rHuPH20).

Each Phase was separated by a washout period of 5 to 21 days.

Group Type: EXPERIMENTAL

Recombinant human hyaluronidase PH20

Intervention Type: DRUG

Insulin aspart

Intervention Type: DRUG

Insulin lispro

Intervention Type: DRUG

Interventions

Sham Injection

Intervention Type: DRUG

Recombinant human hyaluronidase PH20

Intervention Type: DRUG

Insulin aspart

Intervention Type: DRUG

Insulin lispro

Intervention Type: DRUG

Other Intervention Names

rHuPH20; PH20; Hylenex; Novolog; Aspart; Humalog; Lispro

Eligibility Criteria

Inclusion Criteria

1. Males or females 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.

2. Non-smoking participants with Type 1 diabetes mellitus (T1DM) treated with insulin for ≥12 months. Nonsmoking means abstinence from cigarettes and cigars for 3 months and negative cotinine screening tests at screening.

3. Body mass index (BMI) 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive.

4. Glycosylated hemoglobin A1c (HbA1c) ≤10% based on local laboratory results.

5. Fasting connecting peptide of insulin (C-peptide) <0.6 nanograms per milliliter (ng/mL).

6. Current treatment with insulin <90 units per day (U/d).

7. Current use of rapid acting insulin analog.

8. Routine use of CSII as the primary route of insulin administration for at least 3 months prior to screening

9. 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 the study protocol.

Exclusion Criteria

1. Known or suspected allergy to any component of any of the study drugs in this study.

2. Previous enrollment in this study.

3. Use of drugs that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia. Participants taking maintenance doses of blood thinners (for example, coumadin or heparin) will be excluded.

4. Use of any long-acting insulin injection within 72 hours of Study Day 1; participants will continue to refrain from use throughout the duration of the study (Phases I and II).

5. Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator.

6. Current addiction to alcohol or substances of abuse as determined by the Investigator.

7. Blood donation or phlebotomy (>500 milliliters [mL]) within the previous 8 weeks of the Screening Visit(s) in this study.

8. Pregnancy, breastfeeding, 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, or barrier methods).

9. Symptomatic gastroparesis.

10. Receipt of any investigational drug within 4 weeks of Study Day 1.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Halozyme Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Linda Morrow, MD

Role: PRINCIPAL_INVESTIGATOR

Profil Institute for Clinical Research, Inc.

Locations

Profil Institute for Clinical Research

Chula Vista, California, United States

Countries

United States

Related Links

http://www.halozyme.com

Sponsor's Website

Other Identifiers

Halo-117-401

Identifier Type: -

Identifier Source: org_study_id