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Assessing the Efficacy, Safety, and Tolerability of Met DR in Subjects With T2DM Over 12 Weeks

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elcelyx Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01819272
First received: March 19, 2013
Last updated: August 21, 2015
Last verified: August 2015
Results First Received: August 21, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Met DR
Drug: Met XR

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo once daily in the morning
600 mg DR

600 mg delayed-release metformin once daily in the morning

Met DR: metformin delayed-release tablets

800 mg DR

800 mg delayed-release metformin once daily in the morning

Met DR: metformin delayed-release tablets

1000 mg DR

1000 mg delayed-release metformin once daily in the morning

Met DR: metformin delayed-release tablets

1000 mg XR

1000 mg extended-release metformin once daily in the evening

Met XR: metformin extended-release tablets

2000 mg XR

2000 mg extended-release metformin once daily in the evening

Met XR: metformin extended-release tablets


Participant Flow:   Overall Study
    Placebo   600 mg DR   800 mg DR   1000 mg DR   1000 mg XR   2000 mg XR
STARTED   41   39   40   40   40   40 
COMPLETED   35   36   37   35   36   33 
NOT COMPLETED   6   3   3   5   4   7 
Adverse Event                1                0                0                2                0                0 
Lost to Follow-up                3                0                1                0                0                3 
Protocol Violation                0                0                0                1                2                3 
Physician Decision                0                1                0                0                0                0 
Withdrawal of Consent                0                1                2                1                0                1 
Loss of Glucose Control                2                1                0                1                2                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.
ITT Population

Reporting Groups
  Description
Placebo Placebo once daily in the morning
600 mg DR

600 mg delayed-release metformin once daily in the morning

Met DR: metformin delayed-release tablets

800 mg DR

800 mg delayed-release metformin once daily in the morning

Met DR: metformin delayed-release tablets

1000 mg DR

1000 mg delayed-release metformin once daily in the morning

Met DR: metformin delayed-release tablets

1000 mg XR

1000 mg extended-release metformin once daily in the evening

Met XR: metformin extended-release tablets

2000 mg XR

2000 mg extended-release metformin once daily in the evening

Met XR: metformin extended-release tablets

Total Total of all reporting groups

Baseline Measures
   Placebo   600 mg DR   800 mg DR   1000 mg DR   1000 mg XR   2000 mg XR   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   39   40   40   40   40   240 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.4  (10.22)   53.5  (8.34)   52.6  (9.69)   51.8  (9.05)   51.0  (9.62)   52.0  (9.53)   52.0  (9.37) 
Gender 
[Units: Participants]
             
Female   22   21   27   14   22   21   127 
Male   19   18   13   26   18   19   113 
Ethnicity (NIH/OMB) 
[Units: Participants]
             
Hispanic or Latino   17   14   10   14   10   10   75 
Not Hispanic or Latino   24   25   30   26   30   30   165 
Unknown or Not Reported   0   0   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
             
American Indian or Alaska Native   1   0   0   0   0   0   1 
Asian   1   0   3   0   2   0   6 
Native Hawaiian or Other Pacific Islander   0   0   1   0   0   0   1 
Black or African American   11   9   13   9   14   12   68 
White   28   30   23   30   24   27   162 
More than one race   0   0   0   0   0   0   0 
Unknown or Not Reported   0   0   0   1   0   1   2 
BMI 
[Units: Kg/m²]
Mean (Standard Deviation)
 33.6  (5.28)   33.1  (5.74)   33.5  (5.86)   33.3  (5.55)   32.8  (5.27)   33.7  (5.22)   33.3  (5.44) 
Previous T2DM Regimen 
[Units: Participants]
             
Diet and exercise alone   3   7   2   4   6   5   27 
DPP-4 inhibitor alone   0   1   0   0   0   0   1 
Metformin alone   35   29   35   36   30   33   198 
Metformin/DPP-4 inhibitor combination   3   2   3   0   4   2   14 
Screening Fasting Plasma Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 146.5  (36.70)   147.5  (42.56)   142.4  (34.60)   141.4  (29.79)   139.0  (34.22)   148.9  (41.36)   144.3  (36.57) 
Screening HbA1c 
[Units: %]
Mean (Standard Deviation)
 7.19  (0.838)   7.27  (0.864)   7.17  (0.829)   7.13  (0.899)   7.10  (0.819)   7.17  (0.869)   7.17  (0.846) 
Baseline Fasting Plasma Glucose 
[Units: mg/dL]
Mean (Standard Deviation)
 176.5  (54.70)   180.1  (49.72)   162.9  (40.10)   172.3  (44.45)   165.7  (50.01)   180.3  (57.52)   173.0  (49.72) 
Baseline HbA1c 
[Units: %]
Mean (Standard Deviation)
 7.40  (0.951)   7.45  (0.887)   7.33  (0.908)   7.37  (0.890)   7.36  (0.997)   7.38  (0.980)   7.38  (0.928) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Fasting Plasma Glucose (mg/dL) at 4 Weeks   [ Time Frame: Baseline and 4 weeks after the first dose of study medication ]

2.  Secondary:   AUC4-12wk of Change in Fasting Plasma Glucose (mg/dL*Week) Concentrations From Baseline to 12 Weeks   [ Time Frame: Baseline and 4 to 12 weeks after the first dose of study medication ]

3.  Secondary:   Change in HbA1c (%) at 12 Weeks   [ Time Frame: Baseline and 12 weeks after the first dose of study medication ]


  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: Senior Director, Development
Organization: Elcelyx Therapeutics, Inc
phone: 858-876-1814
e-mail: info@elcelyx.com


Publications:

Responsible Party: Elcelyx Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01819272     History of Changes
Other Study ID Numbers: LCRM105
Study First Received: March 19, 2013
Results First Received: August 21, 2015
Last Updated: August 21, 2015
Health Authority: United States: Food and Drug Administration