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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01194258
First received: August 31, 2010
Last updated: August 1, 2014
Last verified: August 2014
Results First Received: August 1, 2014  
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
Condition: Diabetes Mellitus, Type II
Interventions: Drug: Insulin lispro
Drug: Insulin aspart
Drug: Recombinant human hyaluronidase PH20
Drug: Insulin glulisine
Drug: Insulin glargine

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants in the study, including those who were enrolled but were not randomized.

Reporting Groups
  Description
All Study Participants All participants in the study, including those who were enrolled but were not randomized.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  132  
Age  
[units: years]
Mean ± Standard Deviation
  58.7  ± 9.85  
Gender  
[units: participants]
 
Female     53  
Male     79  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     3  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     10  
White     115  
More than one race     1  
Unknown or Not Reported     2  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     19  
Not Hispanic or Latino     113  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     132  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period   [ Time Frame: Baseline, Week 12 and Week 24 ]

2.  Secondary:   Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring   [ Time Frame: Week 10 and Week 22 ]

3.  Secondary:   Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time   [ Time Frame: Baseline through Week 24, excluding 10-point glucose monitoring days ]

4.  Secondary:   Rates of Hypoglycemia at the End of Each Treatment Period   [ Time Frame: Week 12 and Week 24 ]

5.  Secondary:   Change From Baseline in Body Weight at the End of Each Treatment Period   [ Time Frame: Baseline, Week 12 and Week 24 ]

6.  Secondary:   Mean Daily PPG Excursions   [ Time Frame: Week 10 and Week 22 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Endocrinology Clinical Development
Organization: Halozyme Therapeutics
phone: 858-794-8889


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
Results First Received: August 1, 2014
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration