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

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type II

In brief

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.

Key facts

Study ID

NCT01194258

Run by

Halozyme Therapeutics

People needed

132

Starts

2010-08-01

Expected to finish

2011-08-01

Last updated by the study team

2014-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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