Status:
COMPLETED
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Diabetes Mellitus, Type II
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 diabet...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT01194258
Start Date
August 1 2010
End Date
August 1 2011
Last Update
August 20 2014
Active Locations (22)
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1
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
2
Medical Group of Encino
Encino, California, United States, 91436
3
AMCR Institute, Inc.
Escondido, California, United States, 92026
4
Marin Endocrine Care and Research
Greenbrae, California, United States, 94904