Fasiglifam 25 mg BID vs 50 mg QD
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Fasiglifam; Placebo to fasiglifam
Intervention description: Fasiglifam tablets; Fasiglifam placebo-matching tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      To evaluate the efficacy of fasiglifam 25 mg twice daily (BID) and fasiglifam 50 mg once
      daily (QD) on glycemic control in adults with type 2 diabetes who are inadequately controlled
      on diet and exercise alone.
    

Eligibility criteria:

        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.