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Study of TAK-875 in Adults With Type 2 Diabetes and Cardiovascular Disease or Risk Factors for Cardiovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01609582
Recruitment Status : Terminated (Due to potential concerns about liver safety (See Detailed Description))
First Posted : June 1, 2012
Results First Posted : August 21, 2015
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Type 2 Diabetes
Cardiovascular Disease
Interventions Drug: TAK-875
Drug: TAK-875 Placebo
Enrollment 3207
Recruitment Details Participants took part in the study at 469 investigative sites in 31 countries; 192 sites in North America, 175 in the Europe, Middle East, and Africa (EMEA) region (including Russia, Ukraine, Israel, and South Africa), 65 in the Asia Pacific region, and 37 in Latin/South America from 01 June 2012 to 05 May 2014.
Pre-assignment Details Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM) and clinically-evident cardiovascular (CV) disease or multiple risk factors for CV events who were inadequately controlled while receiving the standard of care were enrolled in 1 of 2 treatment groups: placebo; fasiglifam 50 milligram (mg).
Arm/Group Title Placebo Fasiglifam 50 mg
Hide Arm/Group Description Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days. Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
Period Title: Overall Study
Started 1603 1604
Treated 1603 1601
Completed 0 0
Not Completed 1603 1604
Reason Not Completed
Adverse Event             20             18
Lost to Follow-up             10             10
Withdrawal by Subject             21             15
Study Terminated by Sponsor             1543             1548
Other             9             10
Randomized, but not treated             0             3
Arm/Group Title Placebo Fasiglifam 50 mg Total
Hide Arm/Group Description Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days. Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days. Total of all reporting groups
Overall Number of Baseline Participants 1603 1604 3207
Hide Baseline Analysis Population Description
The randomized set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1603 participants 1604 participants 3207 participants
63.9  (9.03) 63.4  (9.20) 63.7  (9.12)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1603 participants 1604 participants 3207 participants
Less than (<) 65 years 794 851 1645
Greater than or equal to (>=) 65 years 809 753 1562
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1603 participants 1604 participants 3207 participants
Female
543
  33.9%
563
  35.1%
1106
  34.5%
Male
1060
  66.1%
1041
  64.9%
2101
  65.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1603 participants 1604 participants 3207 participants
Hispanic or Latino
150
   9.4%
119
   7.4%
269
   8.4%
Not Hispanic or Latino
446
  27.8%
477
  29.7%
923
  28.8%
Unknown or Not Reported
1007
  62.8%
1008
  62.8%
2015
  62.8%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1603 participants 1604 participants 3207 participants
American Indian or Alaska Native 47 41 88
Asian 199 205 404
Native Hawaiian or Other Pacific Islander 6 7 13
Black or African American 79 95 174
White 1265 1246 2511
Multiracial/More than 1 race 7 10 17
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 1603 participants 1604 participants 3207 participants
168.1  (9.84) 167.6  (10.54) 167.8  (10.20)
[1]
Measure Description: For this outcome measure, number of participants evaluable were 1598 and 1597 for each arm, respectively.
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 1603 participants 1604 participants 3207 participants
91.14  (19.832) 91.40  (21.319) 91.27  (20.586)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 1603 participants 1604 participants 3207 participants
32.14  (6.107) 32.45  (7.497) 32.30  (6.838)
[1]
Measure Description: For this outcome measure, number of participants evaluable were 1598 and 1597 for each arm, respectively.
Glycosylated Hemoglobin (HbA1c) Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1603 participants 1604 participants 3207 participants
<8.5 percent (%) 988 936 1924
>=8.5% 615 668 1283
Smoking Classification  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1603 participants 1604 participants 3207 participants
Never smoked 667 668 1335
Current smoker 330 328 658
Ex-smoker 606 608 1214
Duration of Diabetes   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1603 participants 1604 participants 3207 participants
13.583  (8.409) 13.333  (8.321) 13.458  (8.365)
[1]
Measure Description: For this outcome measure, number of participants evaluable were 1602 and 1602 for each arm, respectively.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1603 participants 1604 participants 3207 participants
Argentina 121 121 242
Australia 34 35 69
Bulgaria 21 22 43
Canada 104 107 211
Croatia 16 17 33
Czech Republic 56 56 112
Estonia 13 11 24
France 3 4 7
Germany 30 30 60
Hong Kong 29 29 58
Hungary 74 72 146
Israel 25 26 51
Italy 3 3 6
Korea, Republic of 29 27 56
Latvia 11 11 22
Lithuania 15 15 30
Malaysia 30 31 61
Mexico 26 26 52
New Zealand 20 20 40
Peru 18 17 35
Philippines 25 24 49
Poland 118 118 236
Romania 5 4 9
Russian Federation 25 23 48
Slovakia 31 31 62
South Africa 10 10 20
Taiwan, Province of China 31 31 62
Thailand 29 32 61
Ukraine 76 76 152
United Kingdom 16 16 32
United States 559 559 1118
1.Primary Outcome
Title Time to First Occurrence of Any Component of Primary Major Adverse Cardiovascular Event (MACE) Composite
Hide Description The time from randomization to the first occurrences of any event in the primary MACE composite was evaluated using Kaplan-Meier analysis. The primary MACE composite comprised cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, and hospitalization for unstable angina (with or without revascularization).
Time Frame Baseline up to end of study (up to Day 588)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.
Arm/Group Title Placebo Fasiglifam 50 mg
Hide Arm/Group Description:
Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
Overall Number of Participants Analyzed 1603 1604
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median time and corresponding 95% confidence interval could not be reached since very low number of participants (<50%) had event related to any component of primary MACE composite.
2.Secondary Outcome
Title Time to First Occurrence of Any Component of Secondary Major Adverse Cardiovascular Event (MACE) Composite
Hide Description The time from randomization to the first occurrences of any event in the secondary MACE composite was evaluated using Kaplan-Meier analysis. The secondary MACE composite comprised CV death, nonfatal MI, and nonfatal stroke.
Time Frame Baseline up to end of study (up to Day 588)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized participants who had baseline and at least 1 post-baseline assessment.
Arm/Group Title Placebo Fasiglifam 50 mg
Hide Arm/Group Description:
Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
Overall Number of Participants Analyzed 1603 1604
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median time and corresponding 95% confidence interval could not be reached since very low number of participants (<50%) had event related to any component of secondary MACE composite.
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 30 days after the last dose of double-blind study drug.
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Placebo Fasiglifam 50 mg
Hide Arm/Group Description Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days. Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
All-Cause Mortality
Placebo Fasiglifam 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Fasiglifam 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   197/1603 (12.29%)   201/1601 (12.55%) 
Blood and lymphatic system disorders     
Anaemia  1  1/1603 (0.06%)  3/1601 (0.19%) 
Cardiac disorders     
Atrioventricular block first degree  1  3/1603 (0.19%)  3/1601 (0.19%) 
Atrioventricular block  1  0/1603 (0.00%)  1/1601 (0.06%) 
Atrioventricular block complete  1  1/1603 (0.06%)  0/1601 (0.00%) 
Cardiac disorder  1  1/1603 (0.06%)  0/1601 (0.00%) 
Intracardiac thrombus  1  0/1603 (0.00%)  1/1601 (0.06%) 
Ischaemic cardiomyopathy  1  0/1603 (0.00%)  1/1601 (0.06%) 
Coronary artery disease  1  7/1603 (0.44%)  6/1601 (0.37%) 
Coronary artery occlusion  1  0/1603 (0.00%)  2/1601 (0.12%) 
Cardiac failure congestive  1  7/1603 (0.44%)  12/1601 (0.75%) 
Cardiac failure chronic  1  0/1603 (0.00%)  1/1601 (0.06%) 
Acute myocardial infarction  1  9/1603 (0.56%)  12/1601 (0.75%) 
Arteriosclerosis coronary artery  1  1/1603 (0.06%)  0/1601 (0.00%) 
Cardiac failure  1  2/1603 (0.12%)  4/1601 (0.25%) 
Cardiogenic shock  1  0/1603 (0.00%)  1/1601 (0.06%) 
Angina pectoris  1  7/1603 (0.44%)  9/1601 (0.56%) 
Angina unstable  1  5/1603 (0.31%)  7/1601 (0.44%) 
Myocardial infarction  1  5/1603 (0.31%)  4/1601 (0.25%) 
Acute coronary syndrome  1  3/1603 (0.19%)  3/1601 (0.19%) 
Myocardial ischaemia  1  4/1603 (0.25%)  1/1601 (0.06%) 
Left ventricular failure  1  1/1603 (0.06%)  0/1601 (0.00%) 
Mitral valve incompetence  1  1/1603 (0.06%)  0/1601 (0.00%) 
Arrhythmia  1  0/1603 (0.00%)  3/1601 (0.19%) 
Right ventricular failure  1  1/1603 (0.06%)  0/1601 (0.00%) 
Atrial fibrillation  1  4/1603 (0.25%)  1/1601 (0.06%) 
Sinus bradycardia  1  1/1603 (0.06%)  0/1601 (0.00%) 
Cardiac arrest  1  1/1603 (0.06%)  4/1601 (0.25%) 
Cardio-respiratory arrest  1  2/1603 (0.12%)  1/1601 (0.06%) 
Ear and labyrinth disorders     
Vertigo  1  0/1603 (0.00%)  2/1601 (0.12%) 
Endocrine disorders     
Pituitary haemorrhage  1  1/1603 (0.06%)  0/1601 (0.00%) 
Eye disorders     
Cataract  1  1/1603 (0.06%)  0/1601 (0.00%) 
Retinal haemorrhage  1  1/1603 (0.06%)  0/1601 (0.00%) 
Diabetic retinopathy  1  1/1603 (0.06%)  0/1601 (0.00%) 
Gastrointestinal disorders     
Abdominal hernia  1  0/1603 (0.00%)  1/1601 (0.06%) 
Pancreatitis  1  2/1603 (0.12%)  0/1601 (0.00%) 
Pancreatitis acute  1  0/1603 (0.00%)  1/1601 (0.06%) 
Large intestine polyp  1  1/1603 (0.06%)  2/1601 (0.12%) 
Colitis  1  1/1603 (0.06%)  0/1601 (0.00%) 
Diarrhoea  1  1/1603 (0.06%)  0/1601 (0.00%) 
Diverticulum  1  1/1603 (0.06%)  0/1601 (0.00%) 
Small intestinal obstruction  1  1/1603 (0.06%)  2/1601 (0.12%) 
Duodenal ulcer  1  0/1603 (0.00%)  2/1601 (0.12%) 
Obstruction gastric  1  0/1603 (0.00%)  1/1601 (0.06%) 
Gastritis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Gastroduodenitis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Abdominal pain  1  1/1603 (0.06%)  1/1601 (0.06%) 
Abdominal pain upper  1  0/1603 (0.00%)  1/1601 (0.06%) 
Constipation  1  0/1603 (0.00%)  1/1601 (0.06%) 
Duodenitis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Abdominal discomfort  1  0/1603 (0.00%)  1/1601 (0.06%) 
Haemorrhoids  1  1/1603 (0.06%)  1/1601 (0.06%) 
Rectal haemorrhage  1  1/1603 (0.06%)  1/1601 (0.06%) 
Anal haemorrhage  1  1/1603 (0.06%)  0/1601 (0.00%) 
Nausea  1  0/1603 (0.00%)  1/1601 (0.06%) 
Gastrointestinal haemorrhage  1  2/1603 (0.12%)  3/1601 (0.19%) 
Haematemesis  1  1/1603 (0.06%)  0/1601 (0.00%) 
Haematochezia  1  1/1603 (0.06%)  0/1601 (0.00%) 
Oesophageal stenosis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Pancreatic calcification  1  1/1603 (0.06%)  0/1601 (0.00%) 
General disorders     
Medical device pain  1  1/1603 (0.06%)  0/1601 (0.00%) 
Death  1  1/1603 (0.06%)  0/1601 (0.00%) 
Sudden death  1  1/1603 (0.06%)  0/1601 (0.00%) 
Device malfunction  1  0/1603 (0.00%)  2/1601 (0.12%) 
Local swelling  1  0/1603 (0.00%)  1/1601 (0.06%) 
Oedema peripheral  1  1/1603 (0.06%)  0/1601 (0.00%) 
Chest pain  1  6/1603 (0.37%)  8/1601 (0.50%) 
Non-cardiac chest pain  1  3/1603 (0.19%)  4/1601 (0.25%) 
Chest discomfort  1  1/1603 (0.06%)  0/1601 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/1603 (0.06%)  3/1601 (0.19%) 
Cholelithiasis  1  2/1603 (0.12%)  2/1601 (0.12%) 
Cholecystitis acute  1  2/1603 (0.12%)  0/1601 (0.00%) 
Jaundice cholestatic  1  0/1603 (0.00%)  1/1601 (0.06%) 
Hepatic mass  1  1/1603 (0.06%)  0/1601 (0.00%) 
Infections and infestations     
Gastroenteritis  1  1/1603 (0.06%)  4/1601 (0.25%) 
Appendicitis  1  1/1603 (0.06%)  1/1601 (0.06%) 
Diverticulitis  1  1/1603 (0.06%)  0/1601 (0.00%) 
Cellulitis  1  2/1603 (0.12%)  6/1601 (0.37%) 
Gangrene  1  1/1603 (0.06%)  2/1601 (0.12%) 
Diabetic gangrene  1  1/1603 (0.06%)  2/1601 (0.12%) 
Osteomyelitis  1  1/1603 (0.06%)  1/1601 (0.06%) 
Intervertebral discitis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Extradural abscess  1  1/1603 (0.06%)  0/1601 (0.00%) 
Clostridium difficile colitis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Abscess  1  0/1603 (0.00%)  1/1601 (0.06%) 
Abscess limb  1  1/1603 (0.06%)  0/1601 (0.00%) 
Wound infection  1  1/1603 (0.06%)  0/1601 (0.00%) 
Influenza  1  1/1603 (0.06%)  0/1601 (0.00%) 
Pneumonia  1  5/1603 (0.31%)  7/1601 (0.44%) 
Bronchitis  1  1/1603 (0.06%)  3/1601 (0.19%) 
Lung infection  1  0/1603 (0.00%)  1/1601 (0.06%) 
Sepsis  1  2/1603 (0.12%)  3/1601 (0.19%) 
Urosepsis  1  1/1603 (0.06%)  1/1601 (0.06%) 
Diabetic foot infection  1  1/1603 (0.06%)  0/1601 (0.00%) 
Infected skin ulcer  1  1/1603 (0.06%)  0/1601 (0.00%) 
Paronychia  1  0/1603 (0.00%)  1/1601 (0.06%) 
Staphylococcal bacteraemia  1  1/1603 (0.06%)  0/1601 (0.00%) 
Staphylococcal infection  1  0/1603 (0.00%)  1/1601 (0.06%) 
Erysipelas  1  0/1603 (0.00%)  1/1601 (0.06%) 
Streptococcal infection  1  1/1603 (0.06%)  0/1601 (0.00%) 
Streptococcal urinary tract infection  1  1/1603 (0.06%)  0/1601 (0.00%) 
Pulmonary tuberculosis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Laryngitis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Upper respiratory tract infection  1  0/1603 (0.00%)  1/1601 (0.06%) 
Urinary tract infection  1  1/1603 (0.06%)  2/1601 (0.12%) 
Gastrointestinal viral infection  1  0/1603 (0.00%)  1/1601 (0.06%) 
Pneumonia viral  1  1/1603 (0.06%)  0/1601 (0.00%) 
Injury, poisoning and procedural complications     
Postpericardiotomy syndrome  1  1/1603 (0.06%)  0/1601 (0.00%) 
Vascular pseudoaneurysm  1  1/1603 (0.06%)  0/1601 (0.00%) 
Subdural haematoma  1  1/1603 (0.06%)  1/1601 (0.06%) 
Joint dislocation  1  1/1603 (0.06%)  0/1601 (0.00%) 
Traumatic fracture  1  0/1603 (0.00%)  1/1601 (0.06%) 
Ankle fracture  1  2/1603 (0.12%)  2/1601 (0.12%) 
Hip fracture  1  1/1603 (0.06%)  1/1601 (0.06%) 
Femur fracture  1  1/1603 (0.06%)  0/1601 (0.00%) 
Foot fracture  1  1/1603 (0.06%)  0/1601 (0.00%) 
Tibia fracture  1  0/1603 (0.00%)  1/1601 (0.06%) 
Tendon injury  1  1/1603 (0.06%)  0/1601 (0.00%) 
Fall  1  1/1603 (0.06%)  2/1601 (0.12%) 
Incisional hernia  1  0/1603 (0.00%)  1/1601 (0.06%) 
Post procedural complication  1  1/1603 (0.06%)  0/1601 (0.00%) 
Wound dehiscence  1  1/1603 (0.06%)  0/1601 (0.00%) 
Accidental overdose  1  1/1603 (0.06%)  0/1601 (0.00%) 
Contusion  1  1/1603 (0.06%)  1/1601 (0.06%) 
Laceration  1  1/1603 (0.06%)  0/1601 (0.00%) 
Lumbar vertebral fracture  1  0/1603 (0.00%)  1/1601 (0.06%) 
Humerus fracture  1  1/1603 (0.06%)  0/1601 (0.00%) 
Wrist fracture  1  1/1603 (0.06%)  0/1601 (0.00%) 
Investigations     
Blood glucose increased  1  1/1603 (0.06%)  0/1601 (0.00%) 
International normalised ratio increased  1  0/1603 (0.00%)  1/1601 (0.06%) 
Electrocardiogram ST segment elevation  1  1/1603 (0.06%)  0/1601 (0.00%) 
Angiogram  1  0/1603 (0.00%)  1/1601 (0.06%) 
Metabolism and nutrition disorders     
Diabetes mellitus inadequate control  1  2/1603 (0.12%)  1/1601 (0.06%) 
Type 2 diabetes mellitus  1  0/1603 (0.00%)  1/1601 (0.06%) 
Diabetic ketoacidosis  1  2/1603 (0.12%)  0/1601 (0.00%) 
Hyperglycaemia  1  4/1603 (0.25%)  1/1601 (0.06%) 
Hypoglycaemia  1  4/1603 (0.25%)  5/1601 (0.31%) 
Fluid overload  1  0/1603 (0.00%)  1/1601 (0.06%) 
Musculoskeletal and connective tissue disorders     
Bursitis  1  1/1603 (0.06%)  0/1601 (0.00%) 
Polymyalgia rheumatica  1  0/1603 (0.00%)  1/1601 (0.06%) 
Gouty arthritis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Intervertebral disc degeneration  1  1/1603 (0.06%)  0/1601 (0.00%) 
Intervertebral disc protrusion  1  1/1603 (0.06%)  0/1601 (0.00%) 
Back pain  1  1/1603 (0.06%)  1/1601 (0.06%) 
Neck pain  1  0/1603 (0.00%)  1/1601 (0.06%) 
Spinal pain  1  1/1603 (0.06%)  0/1601 (0.00%) 
Osteoarthritis  1  1/1603 (0.06%)  1/1601 (0.06%) 
Spinal osteoarthritis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Spinal column stenosis  1  0/1603 (0.00%)  2/1601 (0.12%) 
Spondylolisthesis  1  1/1603 (0.06%)  0/1601 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cholangiocarcinoma  1  1/1603 (0.06%)  1/1601 (0.06%) 
Bone cancer metastatic  1  1/1603 (0.06%)  0/1601 (0.00%) 
Invasive ductal breast carcinoma  1  1/1603 (0.06%)  0/1601 (0.00%) 
Adenocarcinoma gastric  1  1/1603 (0.06%)  0/1601 (0.00%) 
Gastric cancer stage IV  1  0/1603 (0.00%)  1/1601 (0.06%) 
Large intestine benign neoplasm  1  1/1603 (0.06%)  0/1601 (0.00%) 
Hepatic cancer  1  1/1603 (0.06%)  0/1601 (0.00%) 
Hepatocellular carcinoma  1  1/1603 (0.06%)  0/1601 (0.00%) 
Metastatic neoplasm  1  0/1603 (0.00%)  1/1601 (0.06%) 
Metastatic squamous cell carcinoma  1  0/1603 (0.00%)  1/1601 (0.06%) 
Brain neoplasm  1  0/1603 (0.00%)  1/1601 (0.06%) 
Non-small cell lung cancer  1  1/1603 (0.06%)  0/1601 (0.00%) 
Squamous cell carcinoma of lung  1  0/1603 (0.00%)  1/1601 (0.06%) 
Pancreatic carcinoma  1  1/1603 (0.06%)  0/1601 (0.00%) 
Prostate cancer  1  1/1603 (0.06%)  1/1601 (0.06%) 
Rectosigmoid cancer  1  0/1603 (0.00%)  1/1601 (0.06%) 
Lung neoplasm malignant  1  1/1603 (0.06%)  1/1601 (0.06%) 
Malignant melanoma  1  0/1603 (0.00%)  1/1601 (0.06%) 
Metastatic malignant melanoma  1  0/1603 (0.00%)  1/1601 (0.06%) 
Transitional cell carcinoma  1  1/1603 (0.06%)  0/1601 (0.00%) 
Bladder neoplasm  1  0/1603 (0.00%)  1/1601 (0.06%) 
Uterine cancer  1  0/1603 (0.00%)  1/1601 (0.06%) 
Nervous system disorders     
Dementia Alzheimer's type  1  0/1603 (0.00%)  1/1601 (0.06%) 
Cerebrovascular accident  1  7/1603 (0.44%)  1/1601 (0.06%) 
Ischaemic stroke  1  1/1603 (0.06%)  2/1601 (0.12%) 
Cerebral infarction  1  0/1603 (0.00%)  1/1601 (0.06%) 
Embolic stroke  1  1/1603 (0.06%)  0/1601 (0.00%) 
Haemorrhagic stroke  1  1/1603 (0.06%)  0/1601 (0.00%) 
Carotid arteriosclerosis  1  1/1603 (0.06%)  0/1601 (0.00%) 
Syncope  1  5/1603 (0.31%)  3/1601 (0.19%) 
Encephalopathy  1  0/1603 (0.00%)  1/1601 (0.06%) 
VIIth nerve paralysis  1  0/1603 (0.00%)  2/1601 (0.12%) 
Carpal tunnel syndrome  1  1/1603 (0.06%)  0/1601 (0.00%) 
Dizziness  1  1/1603 (0.06%)  1/1601 (0.06%) 
Epilepsy  1  1/1603 (0.06%)  1/1601 (0.06%) 
Central pain syndrome  1  1/1603 (0.06%)  0/1601 (0.00%) 
Transient ischaemic attack  1  1/1603 (0.06%)  3/1601 (0.19%) 
Psychiatric disorders     
Delusion  1  1/1603 (0.06%)  0/1601 (0.00%) 
Depression  1  1/1603 (0.06%)  0/1601 (0.00%) 
Mental status changes  1  0/1603 (0.00%)  1/1601 (0.06%) 
Psychogenic seizure  1  0/1603 (0.00%)  1/1601 (0.06%) 
Suicidal ideation  1  0/1603 (0.00%)  1/1601 (0.06%) 
Renal and urinary disorders     
Urinary retention  1  0/1603 (0.00%)  1/1601 (0.06%) 
Bladder prolapse  1  0/1603 (0.00%)  1/1601 (0.06%) 
Renal failure acute  1  6/1603 (0.37%)  11/1601 (0.69%) 
Renal failure  1  4/1603 (0.25%)  6/1601 (0.37%) 
Renal failure chronic  1  2/1603 (0.12%)  1/1601 (0.06%) 
Prerenal failure  1  1/1603 (0.06%)  0/1601 (0.00%) 
Nephrolithiasis  1  1/1603 (0.06%)  0/1601 (0.00%) 
Renal infarct  1  0/1603 (0.00%)  1/1601 (0.06%) 
Calculus ureteric  1  1/1603 (0.06%)  1/1601 (0.06%) 
Reproductive system and breast disorders     
Prostatitis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  0/1603 (0.00%)  2/1601 (0.12%) 
Respiratory distress  1  1/1603 (0.06%)  0/1601 (0.00%) 
Sleep apnoea syndrome  1  1/1603 (0.06%)  0/1601 (0.00%) 
Chronic obstructive pulmonary disease  1  2/1603 (0.12%)  2/1601 (0.12%) 
Asthma  1  0/1603 (0.00%)  1/1601 (0.06%) 
Pneumonia aspiration  1  0/1603 (0.00%)  1/1601 (0.06%) 
Pleuritic pain  1  1/1603 (0.06%)  0/1601 (0.00%) 
Hypoxia  1  1/1603 (0.06%)  0/1601 (0.00%) 
Interstitial lung disease  1  1/1603 (0.06%)  0/1601 (0.00%) 
Pulmonary fibrosis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Pleural effusion  1  0/1603 (0.00%)  1/1601 (0.06%) 
Pulmonary hypertension  1  1/1603 (0.06%)  1/1601 (0.06%) 
Pulmonary oedema  1  1/1603 (0.06%)  0/1601 (0.00%) 
Pulmonary embolism  1  0/1603 (0.00%)  1/1601 (0.06%) 
Acute respiratory failure  1  1/1603 (0.06%)  3/1601 (0.19%) 
Respiratory failure  1  2/1603 (0.12%)  1/1601 (0.06%) 
Skin and subcutaneous tissue disorders     
Blister  1  0/1603 (0.00%)  1/1601 (0.06%) 
Nail bed inflammation  1  0/1603 (0.00%)  1/1601 (0.06%) 
Diabetic foot  1  3/1603 (0.19%)  1/1601 (0.06%) 
Skin ulcer  1  1/1603 (0.06%)  1/1601 (0.06%) 
Surgical and medical procedures     
Coronary arterial stent insertion  1  1/1603 (0.06%)  0/1601 (0.00%) 
Coronary revascularisation  1  1/1603 (0.06%)  0/1601 (0.00%) 
Foot amputation  1  1/1603 (0.06%)  0/1601 (0.00%) 
Vascular disorders     
Hypertensive crisis  1  0/1603 (0.00%)  3/1601 (0.19%) 
Accelerated hypertension  1  0/1603 (0.00%)  1/1601 (0.06%) 
Aortic stenosis  1  2/1603 (0.12%)  0/1601 (0.00%) 
Circulatory collapse  1  1/1603 (0.06%)  1/1601 (0.06%) 
Haematoma  1  1/1603 (0.06%)  0/1601 (0.00%) 
Arteriosclerosis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Venous occlusion  1  0/1603 (0.00%)  1/1601 (0.06%) 
Peripheral vascular disorder  1  1/1603 (0.06%)  1/1601 (0.06%) 
Peripheral ischaemia  1  3/1603 (0.19%)  3/1601 (0.19%) 
Peripheral arterial occlusive disease  1  1/1603 (0.06%)  2/1601 (0.12%) 
Femoral artery occlusion  1  0/1603 (0.00%)  2/1601 (0.12%) 
Intermittent claudication  1  1/1603 (0.06%)  0/1601 (0.00%) 
Peripheral artery stenosis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Hypertension  1  1/1603 (0.06%)  5/1601 (0.31%) 
Hypotension  1  2/1603 (0.12%)  0/1601 (0.00%) 
Arteriovenous fistula  1  0/1603 (0.00%)  1/1601 (0.06%) 
Vasculitis  1  0/1603 (0.00%)  1/1601 (0.06%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Fasiglifam 50 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   427/1603 (26.64%)   415/1601 (25.92%) 
Blood and lymphatic system disorders     
Anaemia  1  26/1603 (1.62%)  33/1601 (2.06%) 
Gastrointestinal disorders     
Diarrhoea  1  48/1603 (2.99%)  44/1601 (2.75%) 
Nausea  1  35/1603 (2.18%)  33/1601 (2.06%) 
Infections and infestations     
Upper respiratory tract infection  1  87/1603 (5.43%)  75/1601 (4.68%) 
Bronchitis  1  45/1603 (2.81%)  49/1601 (3.06%) 
Urinary tract infection  1  43/1603 (2.68%)  35/1601 (2.19%) 
Nasopharyngitis  1  55/1603 (3.43%)  61/1601 (3.81%) 
Influenza  1  37/1603 (2.31%)  34/1601 (2.12%) 
Sinusitis  1  36/1603 (2.25%)  22/1601 (1.37%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  36/1603 (2.25%)  41/1601 (2.56%) 
Nervous system disorders     
Dizziness  1  30/1603 (1.87%)  39/1601 (2.44%) 
Headache  1  32/1603 (2.00%)  41/1601 (2.56%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  30/1603 (1.87%)  40/1601 (2.50%) 
Vascular disorders     
Hypertension  1  40/1603 (2.50%)  42/1601 (2.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.1)
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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01609582    
Other Study ID Numbers: TAK-875_306
2011-001732-37 ( EudraCT Number )
U1111-1129-7824 ( Registry Identifier: WHO )
TAK-875_306CTIL ( Registry Identifier: Israel MOH )
DOH-27-0313-4117 ( Registry Identifier: SANCTR )
12/SC/0504 ( Registry Identifier: NRES )
NMRR-12-433-12087 ( Registry Identifier: NMRR (Malaysia) )
PHRR130916-000119 ( Registry Identifier: PHRR (Philippines) )
1015031332 ( Registry Identifier: TCTIN )
First Submitted: May 29, 2012
First Posted: June 1, 2012
Results First Submitted: July 24, 2015
Results First Posted: August 21, 2015
Last Update Posted: October 19, 2015