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Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01387737
First received: June 28, 2011
Last updated: May 27, 2014
Last verified: May 2014
Results First Received: March 26, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: TA-7284-Low
Drug: TA-7284-High

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
TA-7284-Low TA-7284 low dose, once daily for 52 weeks
TA-7284-High TA-7284 high dose, once daily for 52 weeks

Participant Flow:   Overall Study
    TA-7284-Low   TA-7284-High
STARTED   584   715 
COMPLETED   532   641 
NOT COMPLETED   52   74 
Adverse Event                20                30 
Lack of Efficacy                1                0 
Physician Decision                3                10 
Withdrawal by Subject                27                31 
Clearly not eligible for the study                1                3 



  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.
No text entered.

Reporting Groups
  Description
TA-7284-Low TA-7284 low dose, once daily for 52 weeks
TA-7284-High TA-7284 high dose, once daily for 52 weeks
Total Total of all reporting groups

Baseline Measures
   TA-7284-Low   TA-7284-High   Total 
Overall Participants Analyzed 
[Units: Participants]
 584   715   1299 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   436   520   956 
>=65 years   148   195   343 
Gender 
[Units: Participants]
     
Female   163   212   375 
Male   421   503   924 


  Outcome Measures

1.  Primary:   Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events   [ Time Frame: 54 weeks ]

2.  Secondary:   Change in HbA1c   [ Time Frame: Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Change in Body Weight   [ Time Frame: Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Change in Blood Pressure   [ Time Frame: Week 52 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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Time Frame Week 52
Additional Description No text entered.

Reporting Groups
  Description
TA-7284-Low TA-7284 low dose, once daily for 52 weeks
TA-7284-High TA-7284 high dose, once daily for 52 weeks

Serious Adverse Events
    TA-7284-Low   TA-7284-High
Total, serious adverse events     
# participants affected / at risk   30/584 (5.14%)   32/715 (4.48%) 
Cardiac disorders     
Acute myocardial infarction     
# participants affected / at risk   1/584 (0.17%)   1/715 (0.14%) 
Angina pectoris     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Myocardial infarction     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Myocardial ischaemia     
# participants affected / at risk   1/584 (0.17%)   1/715 (0.14%) 
Supraventricular tachycardia     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Endocrine disorders     
Thyroiditis subacute     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Gastrointestinal disorders     
Autoimmune pancreatitis     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Colonic polyp     
# participants affected / at risk   3/584 (0.51%)   1/715 (0.14%) 
General disorders     
Mass     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Hepatobiliary disorders     
Bile duct stone     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Cholecystitis acute     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Infections and infestations     
Appendicitis     
# participants affected / at risk   1/584 (0.17%)   2/715 (0.28%) 
Chronic sinusitis     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Diverticulitis     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Epiglottitis     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Gastroenteritis     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Genital herpes     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Lung abscess     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Pharyngitis     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Pneumonia     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Streptococcal sepsis     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Vestibular neuronitis     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Injury, poisoning and procedural complications     
Ankle fracture     
# participants affected / at risk   0/584 (0.00%)   2/715 (0.28%) 
Heat illness     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Ligament injury     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Limb traumatic amputation     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Meniscus lesion     
# participants affected / at risk   1/584 (0.17%)   1/715 (0.14%) 
Radius fracture     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Lumbar spinal stenosis     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Rotator cuff syndrome     
# participants affected / at risk   1/584 (0.17%)   1/715 (0.14%) 
Spondylolisthesis     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bile duct cancer     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Breast cancer     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Colon adenoma     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Colon cancer     
# participants affected / at risk   1/584 (0.17%)   1/715 (0.14%) 
Extranodal marginal zone B-cell lymphoma (MALT type)     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Gastric cancer     
# participants affected / at risk   1/584 (0.17%)   1/715 (0.14%) 
Gastrooesophageal cancer     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Hepatic neoplasm malignant     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Large intestine carcinoma     
# participants affected / at risk   0/584 (0.00%)   2/715 (0.28%) 
Pancreatic carcinoma     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Rectal cancer     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Seminoma     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Vocal cord neoplasm     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Nervous system disorders     
Cerebral infarction     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Lacunar infarction     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Loss of consciousness     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Myelopathy     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Renal and urinary disorders     
Calculus ureteric     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Urethral meatus stenosis     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Reproductive system and breast disorders     
Acquired hydrocele     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Benign prostatic hyperplasia     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
Cervical dysplasia     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Skin and subcutaneous tissue disorders     
Dermal cyst     
# participants affected / at risk   0/584 (0.00%)   1/715 (0.14%) 
Surgical and medical procedures     
Suture removal     
# participants affected / at risk   1/584 (0.17%)   0/715 (0.00%) 
1 Term from vocabulary, MedDRA 15
2 Term from vocabulary, MedDRA 15.1




  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
No text entered.


  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: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
e-mail: cti-inq-ml@ml.mt-pharma.co.jp


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01387737     History of Changes
Other Study ID Numbers: TA-7284-06
Study First Received: June 28, 2011
Results First Received: March 26, 2014
Last Updated: May 27, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare