Clinical trial NCT01194245: Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
Official title: A Phase II, Randomized, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: Type 1 diabetes
Lead sponsor: Halozyme Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-09-02
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 Diabetes Mellitus (T1DM) in basal-bolus therapy.

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 days prior to randomization 2) 90 minute or 2-hour postprandial blood glucose \<220 mg/dL approximately 70% of the time for 7 days prior to randomization and 3) successfully completed 3 days of 10-point glucose monitoring and have at least 4 self-monitored blood glucose values on all non-10-point monitoring days. Participants that did not meet 1 or more of these criteria during a 4- to 6-week Titration Period were not randomized.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period
timeFrame: Baseline, Week 12 and Week 24
Secondary outcomes:
measure: Mean Daily Insulin Dose
timeFrame: Week 10 and Week 22
measure: Percentage of Participants Meeting Glucose Targets
timeFrame: Baseline through Week 24, excluding 10-point glucose monitoring days
measure: Rates of Hypoglycemia at the End of Each Treatment Period
timeFrame: Week 12 and Week 24
measure: Change From Baseline in Body Weight at the End of Each Treatment Period
timeFrame: Baseline, Week 12 and Week 24
measure: Mean Daily Postprandial Glucose (PPG) Excursions
timeFrame: Week 10 and Week 22
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute, Inc.
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: San Mateo
country: United States
facility: Mills-Peninsula Health Services
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Hollywood
country: United States
facility: Center for Diabetes and Endocrine Care
state: Florida
city: Miami
country: United States
facility: Diabetes Research Institute
state: Florida
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Wichita
country: United States
facility: Mid-America Diabetes Associates
state: Kansas
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Hyattsville
country: United States
facility: Medstar Research Institute
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: International Diabetes Center
state: Minnesota
city: Butte
country: United States
facility: Mercury Street Medical
state: Montana
city: Henderson
country: United States
facility: Desert Endocrinology
state: Nevada
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: San Antonio
country: United States
facility: Cetero Research-San Antonio
state: Texas
city: Olympia
country: United States
facility: West Olympia Internal Medicine
state: Washington
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
Study officials:
affiliation: Halozyme Therapeutics
name: Douglas Muchmore, M.D.
role: STUDY_DIRECTOR
References: