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

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Halozyme Therapeutics
• Treatments: Insulin; Insulin Aspart; Insulin Glargine; Insulin glulisine; Insulin Lispro; Insulin, Globin Zinc

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