Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type ii
Treatment insulin lispro
Phase phase 2
Sponsor Halozyme Therapeutics
Start date August 2010
End date September 2013
Trial size 110 participants
Trial identifier NCT01194258, HALO-117-206

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
insulin lispro Lispro-PH20
Insulin lispro (Humalog®), 100 U/mL, SC injection
(Experimental)
insulin lispro Lispro-PH20
Insulin lispro (Humalog®), 100 U/mL, SC injection

Primary Outcomes

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

Secondary Outcomes

Measure
Rates of hypoglycemia
time frame: Week 12 of treatment
Insulin dose
time frame: Week 12 of treatment
Weight change
time frame: Week 12 of treatment
Blood glucose measures
time frame: Week 12 of treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Halozyme Therapeutics.