Status:
COMPLETED
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 Di...
Detailed Description
Criteria for randomization into the study included 1) fasting blood glucose and predinner 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 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT01194245
Start Date
August 1 2010
End Date
August 1 2011
Last Update
February 26 2019
Active Locations (19)
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1
AMCR Institute, Inc.
Escondido, California, United States, 92026
2
Scripps Whittier Diabetes Institute
La Jolla, California, United States, 92037
3
Mills-Peninsula Health Services
San Mateo, California, United States, 94401
4
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045