Study to Evaluate the Efficacy and Safety of Daily Oral TAK-875 25 and 50mg in Asia Pacific Adults With Type 2 Diabetes (GRAND-307)

This study has been terminated.
(Due to potential concerns about liver safety (See Detailed Description))
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01647542
First received: July 19, 2012
Last updated: July 22, 2015
Last verified: July 2015
Results First Received: July 22, 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: TAK-875
Drug: TAK-875 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
Participants took part in the study at 59 investigative sites in Australia, China, the Republic of Korea, New Zealand and Taiwan from 30 July 2012 to 18 March 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM) who were inadequately controlled when treated with only diet, exercise and any antidiabetic agent for less than or equal to (<=) 7 days within 12 weeks prior to Screening, were enrolled in 1 of 3 treatment groups: placebo; fasiglifam 25 milligram (mg); fasiglifam 50 mg.

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
Fasiglifam 25 mg Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
Fasiglifam 50 mg Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.

Participant Flow:   Overall Study
    Placebo     Fasiglifam 25 mg     Fasiglifam 50 mg  
STARTED     131     131     131  
COMPLETED     55     58     59  
NOT COMPLETED     76     73     72  
Major Protocol Deviation                 1                 0                 0  
Adverse Event                 4                 5                 4  
Lost to Follow-up                 0                 2                 2  
Withdrawal by Subject                 6                 4                 0  
Study Termination                 64                 61                 65  
Lack of Efficacy                 1                 1                 0  
Death                 0                 0                 1  



  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.
The randomized set included all participants who were randomized.

Reporting Groups
  Description
Placebo Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
Fasiglifam 25 mg Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
Fasiglifam 50 mg Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Fasiglifam 25 mg     Fasiglifam 50 mg     Total  
Number of Participants  
[units: participants]
  131     131     131     393  
Age  
[units: years]
Mean (Standard Deviation)
  52.7  (12.41)     55.1  (11.89)     53.1  (10.96)     53.6  (11.78)  
Age, Customized  
[units: Participants]
       
Less than (<) 65 years     107     102     111     320  
Greater than or equal to (>=) 65 years     24     29     20     73  
Gender  
[units: Participants]
       
Female     64     61     44     169  
Male     67     70     87     224  
Race/Ethnicity, Customized  
[units: Participants]
       
Asian     128     126     127     381  
Native Hawaiian or Other Pacific Islander     1     2     0     3  
White     2     3     4     9  
Body Mass Index  
[units: Kilogram per square meter (kg/m^2)]
Mean (Standard Deviation)
  26.00  (4.348)     25.97  (3.989)     26.12  (3.516)     26.03  (3.956)  
Smoking Classification  
[units: Participants]
       
Never smoked     89     90     71     250  
Current smoker     31     16     33     80  
Ex-smoker     11     25     27     63  
Glycosylated Hemoglobin (HbA1c) Category  
[units: Participants]
       
< 8.5 percent (%)     98     99     107     304  
>= 8.5%     33     32     24     89  
Enrollment by Region  
[units: Participants]
       
Australia     6     5     6     17  
China     70     70     70     210  
Korea, Republic of     26     29     28     83  
New Zealand     1     2     1     4  
Taiwan, Province of China     28     25     26     79  
Duration of Diabetes [1]
[units: Years]
Mean (Standard Deviation)
  2.293  (3.063)     3.499  (3.64)     2.182  (2.782)     2.652  (3.227)  
[1] For this measure, number of participants evaluable were 125, 122, 124 for each arm respectively.



  Outcome Measures
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1.  Primary:   Change From Baseline in HbA1c at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Percentage of Participants With HbA1c <7% at Week 24   [ Time Frame: Week 24 ]

3.  Secondary:   Change in Fasting Plasma Glucose From Baseline to Week 24   [ Time Frame: Baseline and Week 24 ]

4.  Secondary:   Change From Baseline in 2-hour Postprandial Glucose (PPG) Following Oral Glucose Tolerance Test (OGTT) at Week 24   [ Time Frame: Baseline and Week 24 ]


  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: Medical Director
Organization: Takeda
phone: +1-877-825-3327
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01647542     History of Changes
Other Study ID Numbers: TAK-875_307, U1111-1129-7865
Study First Received: July 19, 2012
Results First Received: July 22, 2015
Last Updated: July 22, 2015
Health Authority: China: Ministry of Health
Australia: National Health and Medical Research Council
New Zealand: Medsafe
Taiwan: Department of Health
Korea: Food and Drug Administration