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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01194245
First received: August 31, 2010
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of the study is to compare Lispro-PH20 or Aspart-PH20 to insulin lispro (Humalog) for the treatment of T1DM in basal-bolus therapy.


Condition Intervention Phase
Diabetes Mellitus, Type 1
 Drug: Insulin LISPRO
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Change in A1C at the end of each treatment period from A1C at randomization. [ Time Frame: Screening, Baseline (week 0), week 12, week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rates of hypoglycemia [ Time Frame: Week 12 of treatment ] [ Designated as safety issue: No ]
    Rate calculated based on 4 weeks of observation

  • Insulin dose [ Time Frame: Week 12 of treatment ] [ Designated as safety issue: No ]
  • Weight change [ Time Frame: Week 12 of treatment ] [ Designated as safety issue: No ]
  • Blood glucose measures [ Time Frame: Week 12 of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: August 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lispro-PH20 compared to Humalog Drug: Insulin LISPRO
Insulin lispro (Humalog®), 100 U/mL, SC injection
Other Names:
  • Lispro-PH20
  • Aspart-PH20
  • Humalog
  • Lantus
Experimental: Aspart-PH20 compared to Humalog Drug: Insulin LISPRO
Insulin lispro (Humalog®), 100 U/mL, SC injection
Other Names:
  • Lispro-PH20
  • Aspart-PH20
  • Humalog
  • Lantus

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females aged ≥18 years.
  • Type 1 diabetes mellitus treated with insulin for ≥12 months.
  • BMI 18.0 to 40.0 kg/m².
  • A1C level 6.7 to 8.2% inclusive.
  • Fasting C-peptide <0.6 ng/mL.
  • Willingness to use 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 (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 two episodes over the last six months) or hypoglycemic unawareness, as judged by the Investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194245

Locations
United States, California
AMCR Institute, Inc.
Escondido, California, United States, 92026
Scripps Whittier Diabetes Institute
La Jolla, California, United States, 92037
Mills-Peninsula Health Services
San Mateo, California, United States, 94401
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Florida
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
Diabetes Research Institute
Miami, Florida, United States, 33136
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
United States, Kansas
Mid-America Diabetes Associates
Wichita, Kansas, United States, 67211
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Medstar Research Institute
Hyattsville, Maryland, United States, 20782
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, Montana
Mercury Street Medical
Butte, Montana, United States, 59701
United States, Nevada
Desert Endocrinology
Henderson, Nevada, United States, 89052
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Texas Diabetes and Endocrinology
Round Rock, Texas, United States, 78681
Cetero Research-San Antonio
San Antonio, Texas, United States, 78229
United States, Washington
West Olympia Internal Medicine
Olympia, Washington, United States, 98502
University of Washington School of Medicine
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Halozyme Therapeutics
Investigators
Study Director: Douglas Muchmore, M.D. Halozyme Therapeutics
  More Information

No publications provided

Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT01194245     History of Changes
Other Study ID Numbers: HALO-117-205
Study First Received: August 31, 2010
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
Type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013