Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Lexicon Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00962065
First received: August 10, 2009
Last updated: February 4, 2011
Last verified: February 2011
Results First Received: February 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: LX4211 Low Dose
Drug: LX4211 High Dose
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a single-center trial in the United States, with 1 investigator participating.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a 14-day washout period and a 5-day diet stabilization period prior to randomization.

Reporting Groups
  Description
Low Dose A low dose of LX4211; daily oral intake for 28 days
High Dose A high dose of LX4211; daily oral intake for 28 days
Placebo Matching placebo dosing with daily oral intake for 28 days

Participant Flow:   Overall Study
    Low Dose     High Dose     Placebo  
STARTED     12     12     12  
COMPLETED     12     12     12  
NOT COMPLETED     0     0     0  



  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.
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Reporting Groups
  Description
Low Dose A low dose of LX4211; daily oral intake for 28 days
High Dose A high dose of LX4211; daily oral intake for 28 days
Placebo Matching placebo dosing with daily oral intake for 28 days
Total Total of all reporting groups

Baseline Measures
    Low Dose     High Dose     Placebo     Total  
Number of Participants  
[units: participants]
  12     12     12     36  
Age  
[units: years]
Mean ± Standard Deviation
  52.7  ± 6.07     52.3  ± 8.40     54.5  ± 7.23     53.2  ± 7.15  
Gender  
[units: participants]
       
Female     6     4     6     16  
Male     6     8     6     20  
Ethnicity (NIH/OMB)  
[units: Participants]
       
Hispanic or Latino     8     10     11     29  
Not Hispanic or Latino     4     2     1     7  
Unknown or Not Reported     0     0     0     0  
Race/Ethnicity, Customized  
[units: Participants]
       
American Indian or Alaska Native     0     2     0     2  
Black or African American     2     0     0     2  
White or Caucasian     10     10     12     32  
Region of Enrollment  
[units: participants]
       
United States     12     12     12     36  



  Outcome Measures
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1.  Primary:   Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion   [ Time Frame: Baseline to Day 28 ]

2.  Secondary:   Change From Baseline at Day 29 in Fasting Plasma Glucose   [ Time Frame: Baseline to Day 29 ]

3.  Secondary:   Change From Baseline at Day 28 in Plasma HbA1c   [ Time Frame: Baseline to Day 28 ]

4.  Secondary:   Change From Baseline at Day 28 in Plasma Fructosamine Level   [ Time Frame: Baseline to Day 28 ]

5.  Secondary:   Change From Baseline at Day 28 in Mean Arterial Pressure   [ Time Frame: Baseline to Day 28 ]

6.  Secondary:   Change From Baseline at Day 28 in Triglycerides   [ Time Frame: Baseline to Day 28 ]


  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: Joel P. Freiman, MD, MPH
Organization: Lexicon Pharmaceuticals, Inc.
phone: 281-863-3000


No publications provided by Lexicon Pharmaceuticals

Publications automatically indexed to this study:

Responsible Party: Joel P. Freiman, MD, MPH - Medical Director, Lexicon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00962065     History of Changes
Other Study ID Numbers: LX4211.1-201-DM, LX4211.201
Study First Received: August 10, 2009
Results First Received: February 4, 2011
Last Updated: February 4, 2011
Health Authority: United States: Food and Drug Administration