Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus

Completed · Phase 2

Conditions studied: Diabetes Mellitus, Type 1

In brief

The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.

Key facts

Study ID

NCT01194245

Run by

Halozyme Therapeutics

People needed

135

Starts

2010-08-01

Expected to finish

2011-08-01

Last updated by the study team

2019-02-26

Who can join

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

You may qualify if…

• Males or females aged ≥18 years
• Type 1 Diabetes Mellitus (T1DM) treated with insulin for ≥12 months
• Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m\^2).
• Hemoglobin A1C (HbA1C) level 6.7% to 8.2%, inclusive
• Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)
• Willingness to use twice daily (BID) insulin glargine 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
• Use of pramlintide within 30 days of Screening
• Use of drugs during the study or within 30 days of Screening (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
• Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the Investigator

Where it is running

• AMCR Institute, Inc. — Escondido, California, United States
• Scripps Whittier Diabetes Institute — La Jolla, California, United States
• Mills-Peninsula Health Services — San Mateo, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• Center for Diabetes and Endocrine Care — Hollywood, Florida, United States
• Diabetes Research Institute — 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
• 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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