Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

Inclusion Criteria

• Written informed consent
• Males and females, 18 to 75 years old, inclusive
• Documented history of T2DM
• Treatment naïve to antihyperglycemic therapy or having received no prior treatment with antihyperglycemic therapy for at least 90 days (TZDs for at least 24 weeks) prior to screening
• Body mass index (BMI) 25 kg/m2 to 45 kg/m2 inclusive at screening
• HbA1c 7% - 10%, inclusive at screening and at the end of the Qualifying Period (Day 14 +2 days)
• Fasting serum glucose (FSG) of ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at screening and at the end of the Qualifying Period (Day 14 +2 days). A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥ 125 mg/dL (6.9 mmol/L) and 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at screening and randomization
• Prolonged QTc interval > 500 msec by ECG at screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
• History of bariatric surgery at any time in the past or any other surgery 3x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3x ULN and/or serum total bilirubin > 2.0 mg/dL
• History of cancer (except non-melanomic skin cancers or cervical in situ) within 5 years prior to screening
• History of alcohol or other drug abuse 20 mg or lovastatin at a daily dose > 40 mg, within 14 days prior to randomization
• Weight-loss medication or anti-obesity medication (prescription or nonprescription) 200 mg daily; if receiving ≤ 200 mg daily, should be on stable doses for ≥ 90 days prior to screening and for the duration of the study
• Expected or current treatment with systemic corticosteroids (oral or injectable) for > 14 days from screening through the end of the Treatment Period. Topical or inhaled corticosteroid formulations are permitted at any time during the study
• If receiving thyroid replacement therapy, should be on stable doses for at least 6 weeks prior to randomization
• Hemoglobin < 12 g/dL for males; or < 11 g/dL for females, at screening
• Participation in another clinical study involving an investigational drug or device < 30 days prior to screening; participation in another clinical study involving an antihyperglycemic therapy < 90 days prior to screening
• Donation of blood < 2 months prior to screening; plans to donate blood while participating in the study
• Females who are pregnant or breastfeeding
• Other condition(s) that, in the opinion of the investigator, would compromise the safety of the subject, would prevent compliance with the study protocol (including the ability to comply with Mixed Meal Tolerance Test [MMTT]), or would compromise the quality of the clinical study