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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01194258
First received: August 31, 2010
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

The purpose of the study is to compare Lispro-PH20 or Aspart-PH20 to insulin lispro (Humalog) for the treatment of T2DM in basal-bolus therapy.


Condition Intervention Phase
Diabetes Mellitus, Type II
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 2 Diabetes

Resource links provided by NLM:


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: Yes ]
  • 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: October 2013
Estimated Primary Completion Date: September 2013 (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 2 diabetes mellitus treated with insulin for ≥12 months and prandial insulin (at least two meals per day) for ≥ 2 months
  • BMI 23.0 to 45.0 kg/m²
  • A1C level 7.0 to 8.5%, 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
  • 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
  • Recurrent severe hypoglycemia (more than two episodes over the last six months) or hypoglycemic unawareness, as judged by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194258

Locations
United States, California
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
Medical Group of Encino
Encino, California, United States, 91436
AMCR Institute, Inc.
Escondido, California, United States, 92026
Marin Endocrine Care and Research
Greenbrae, California, United States, 94904
Mills-Peninsula Health Services
San Mateo, California, United States, 94401
United States, Florida
Center for Diabetes and Endocrine Care
Hollywood, Florida, United States, 33021
Diabetes Research Institute
Miami, Florida, United States, 33136
Baptist Diabetes Associates
Miami, Florida, United States, 33156
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, 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, North Carolina
Diabetes and Endocrinology Associates, PC
Morehead, North Carolina, United States, 28557
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: NCT01194258     History of Changes
Other Study ID Numbers: HALO-117-206
Study First Received: August 31, 2010
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014