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

August 31, 2010
July 30, 2013
August 2010
September 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01194258 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus, Type II
Drug: Insulin LISPRO
Insulin lispro (Humalog®), 100 U/mL, SC injection
Other Names:
  • Lispro-PH20
  • Aspart-PH20
  • Humalog
  • Lantus
  • Experimental: Lispro-PH20 compared to Humalog
    Intervention: Drug: Insulin LISPRO
  • Experimental: Aspart-PH20 compared to Humalog
    Intervention: Drug: Insulin LISPRO
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
110
October 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01194258
HALO-117-206
No
Halozyme Therapeutics
Halozyme Therapeutics
Not Provided
Study Director: Douglas Muchmore, M.D. Halozyme Therapeutics
Halozyme Therapeutics
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP