Fasiglifam 25 mg BID vs 50 mg QD

The drug being tested in this study is called fasiglifam. Fasiglifam is being tested to
treat people who have diabetes. This study will look at glycemic control in people who take
fasiglifam.

The study will enroll approximately 400 patients. Participants will be randomly assigned (by
chance) to one of the three treatment groups—which will remain undisclosed to the patient
and study doctor during the study (unless there is an urgent medical need):

- Fasiglifam 25 mg twice a day

- Fasiglifam 50 mg once daily

- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has
no active ingredient.

All participants will be asked to take one tablet twice each day throughout the study. All
participants will be asked to record any time they have symptoms of hypoglycemia in a diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this
study is 18 weeks. Participants will make 9 visits to the clinic.

Inclusion Criteria:

1. In the opinion of the investigator, the participant is capable of understanding and
complying with protocol requirements.

2. The participant or, when applicable, the participant's legally acceptable
representative signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any study procedures.

3. Is male or female and 18 years of age or older with a historical diagnosis of Type 2
Diabetes Mellitus (T2DM).

4. Has a glycosylated hemoglobin (HbA1c) level ≥7.0% and ≤10.0% and fasting plasma
glucose (FPG) ≤270 mg/dL (15.0 mmol/L) at Screening Visit.

5. Has been treated with diet and exercise but has not received treatment with
antidiabetic agents within 12 weeks prior to Screening Visit (Exception: if a patient
has received other antidiabetic therapy for ≤7 days in total within the 2 months
prior to Screening Visit).

6. Has a body mass index (BMI) ≤45 kg/m^2 at Screening.

7. If regularly using other, non-excluded medications, must be on a stable dose for at
least 4 weeks prior to Screening Visit. However, as needed (PRN) use of prescription
or over-the-counter medications is allowed at the discretion of the investigator.

8. Is able and willing to monitor glucose with a home glucose monitor and consistently
record his or her own blood glucose concentrations and complete subject diaries.

9. A female of childbearing potential who is sexually active with a non-sterilized male
partner agrees to routinely use adequate contraception from signing of the informed
consent throughout the duration of the study and for 30 days after the last dose of
study drug.

Exclusion Criteria:

1. Has received any investigational compound within 30 days prior to Screening Visit or
has received an investigational anti-diabetic drug within the 3 months prior to
Screening Visit.

2. Was randomized into a previous fasiglifam study.

3. Is an immediate family member, study site employee, or is in a dependent relationship
with a study site employee who is involved in conduct of this study (eg, spouse,
parent, child, sibling) or may consent under duress.

4. Has donated or received any blood products within 12 weeks prior to Screening or is
planning to donate blood during the study.

5. Has a hemoglobin ≤12 g/dL (≤120 g/L) for males and ≤10 g/dL (≤100 g/L) for females at
Screening.

6. Has a systolic blood pressure ≥160 mm Hg or diastolic pressure ≥95 mm Hg at Screening

7. Has a history of cancer that has been in remission for <5 years prior to Screening. A
history of basal cell carcinoma or stage 1 squamous cell carcinoma of the skin is
allowed.

8. Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels
>2.0× upper limit of normal (ULN) at Screening.

9. Has a total bilirubin level greater than the ULN at Screening. Exception: if a
patient has documented Gilbert's syndrome the patient will be allowed with an
elevated bilirubin level per the investigator's discretion.

10. Has a serum creatinine ≥1.5 mg/dL (≥133μmol/L) (males) and ≥1.4 mg/dL (≥124 μmol/L)
(females) and/or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2 at
Screening.

11. Has uncontrolled thyroid disease as determined by the investigator.

12. Has a history of laser treatment for proliferative diabetic retinopathy within 6
months prior to Screening.

13. Had gastric banding, or gastric bypass surgery within one year prior to Screening.

14. Has a known history of infection with human immunodeficiency virus (HIV), hepatitis B
virus, or hepatitis C virus.

15. Had coronary angioplasty, coronary stent placement, coronary bypass surgery,
myocardial infarction, unstable angina pectoris, clinically significant abnormal
electrocardiogram (ECG), cerebrovascular accident or transient ischemic attack within
3 months prior to or at Screening.

16. Has a history of hypersensitivity, allergies, or has had an anaphylactic reaction(s)
to any component of fasiglifam.

17. Has a history of drug abuse (defined as illicit drug use) or a history of alcohol
abuse within 2 years prior to Screening.

18. Received excluded medications prior to Screening Visit or is expected to receive
excluded medication.

19. If female, is pregnant (confirmed by laboratory testing, ie, serum/urine human
chorionic gonadotropin (hCG), in females of childbearing potential) or lactating or
intending to become pregnant before, during, or within 1 month after participating in
this study; or intending to donate ova during such time period.

20. The subject is unable to understand verbal or written English or any other language
for which a certified translation of the approved informed consent is available.

21. The subject has any other physical or psychiatric disease or condition that in the
judgment of the investigator may affect life expectancy or may make it difficult to
successfully manage and follow the subject according to the protocol.