Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT01194258

Last Updated: 2014-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-08-31

Brief Summary

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.

Detailed Description

Criteria for randomization into the study included 1) fasting blood glucose and pre-dinner glucose values in the range of 70 to 140 milligrams per deciliter (mg/dL) approximately 60% of the time for 7 days prior to randomization; 2) 90 minute or 2-hour postprandial blood glucose <220 mg/dL approximately 70% of the time for 7 days prior to randomization; and 3) successfully completing 3 days of 10-point glucose monitoring and have at least 4 self-monitored blood glucose values on all non-10-point monitoring days. Participants that did not meet 1 or more of these criteria during a 4- to 6-week Titration Period were not randomized.

Conditions

Diabetes Mellitus, Type II

Study Design

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

Study Groups

Lispro-PH20/Insulin lispro

All enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.

Next, participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.

Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-PH20), injected SC, pre-meals, with doses titrated to each participant individually.

Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually.

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Group Type: EXPERIMENTAL

Insulin lispro

Intervention Type: DRUG

Recombinant human hyaluronidase PH20

Intervention Type: DRUG

Insulin glulisine

Intervention Type: DRUG

Insulin glargine

Intervention Type: DRUG

Aspart-PH20/Insulin Lispro

All enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected SC, pre-meals, with doses titrated to each participant individually.

Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.

Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 µg/mL rHuPH20 (combined: Aspart-PH20), injected SC, pre-meals, with doses titrated to each participant individually.

Insulin lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually.

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Group Type: EXPERIMENTAL

Insulin lispro

Intervention Type: DRUG

Insulin aspart

Intervention Type: DRUG

Recombinant human hyaluronidase PH20

Intervention Type: DRUG

Insulin glulisine

Intervention Type: DRUG

Insulin glargine

Intervention Type: DRUG

Interventions

Insulin lispro

Intervention Type: DRUG

Insulin aspart

Intervention Type: DRUG

Recombinant human hyaluronidase PH20

Intervention Type: DRUG

Insulin glulisine

Intervention Type: DRUG

Insulin glargine

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• Males or females ≥18 years
• Type 2 diabetes mellitus (T2DM) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
• Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m^2)
• Glycosylated hemoglobin (HbA1C) level 7.0 to 8.5%, inclusive
• Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)
• Willingness to use insulin glargine twice a day as basal insulin for the duration of the study
• Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (CGM) during the study

Exclusion Criteria

• Known or suspected allergy to any component of any of the study drugs
• Exclusive use of pre-mixed insulins
• Use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
• Use of sulfonylureas within two months of screening
• Use of drugs (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, during the study or within 30 days of screening
• Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator

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

Sponsors

Halozyme Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Muchmore, M.D.

Role: STUDY_DIRECTOR

Halozyme Therapeutics

Locations

John Muir Physician Network Clinical Research Center

Concord, California, United States

Medical Group of Encino

Encino, California, United States

AMCR Institute, Inc.

Escondido, California, United States

Marin Endocrine Care and Research

Greenbrae, California, United States

Mills-Peninsula Health Services

San Mateo, California, United States

Center for Diabetes and Endocrine Care

Hollywood, Florida, United States

Diabetes Research Institute

Miami, Florida, United States

Baptist Diabetes Associates

Miami, Florida, United States

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, United States

Mid-America Diabetes Associates

Wichita, Kansas, United States

Tulane University Health Sciences Center

New Orleans, Louisiana, United States

Medstar Research Institute

Hyattsville, Maryland, United States

Henry Ford Health System

Detroit, Michigan, United States

International Diabetes Center

Minneapolis, Minnesota, United States

Mercury Street Medical

Butte, Montana, United States

Desert Endocrinology

Henderson, Nevada, United States

Diabetes and Endocrinology Associates, PC

Rudd, North Carolina, United States

UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Texas Diabetes and Endocrinology

Round Rock, Texas, United States

Cetero Research-San Antonio

San Antonio, Texas, United States

West Olympia Internal Medicine

Olympia, Washington, United States

University of Washington School of Medicine

Seattle, Washington, United States

Countries

United States

Other Identifiers

HALO-117-206

Identifier Type: -

Identifier Source: org_study_id