Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects

Inclusion Criteria

• Subjects of any race and gender within the age range of 30 to 70 years.
• All female subjects must be of non-child-bearing potential. For the purposes of this study, this is defined as the subject being amenorrheic for at least 12 consecutive months, or at least 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or women who underwent tubal ligation. Menopausal status will be confirmed by demonstrating levels of follicle stimulating hormone (FSH) 40 - 138 mIU/ml and oestradiol < 20 pg/ml at entry, unless this information is available in the subject's medical record. In the event a subject's menopause status has been clearly established (for example, the subject indicates she has been amenorrheic for 10 years), but FSH and/or oestradiol levels are not consistent with a post-menopausal condition, determination of subject eligibility will be at the discretion of the principal investigator following consultation with the sponsor and medical monitor
• All male subjects must agree with their partners to use double-barrier birth control or abstinence while participating in the study and for 12 weeks following the last dose of study drug.
• Willingness to provide written informed consent to participate in the study
• HbA1c ≥ 7.5 and ≤ 10.5
• Fasting glucose ≥ 160 and ≤ 240 mg/dL
• Body Mass Index (BMI) ≥ 25.0 kg/m^2 and ≤ 40.0 kg/m^2
• On stable metformin medication for at least 3 months (≥ 1.0 g/day) prior to Screening
• No prior history of HIV 1 or 2
• Absence of disease markers for hepatitis B & C virus
• Absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening; normal end organ function
• Have a normal 12-lead ECG or one with abnormality considered to be clinically insignificant
• Have a normal chest X-ray (P. A. View) or one with abnormality considered to be clinically insignificant
• Comprehension of the nature and purpose of the study and compliance with the requirement of the entire protocol

Exclusion Criteria

• Any major illness in the past three months or any significant ongoing chronic medical illness not related to diabetes
• Renal or liver impairment, defined as serum creatinine level of ≥ 1.4 mg/dL for females and ≥ 1.5 mg/dL for males, and greater than two times the upper limit of normal for liver enzymes, respectively.
• History of or current gastro-intestinal diseases influencing drug absorption, except for appendectomy
• History, within 3 years, of drug abuse (including Benzodiazepines, opioids, amphetamine, cocaine, and THC)
• History of alcoholism (more than two years), moderate drinkers (more than three drinks per day) or having consumed alcohol within 48 hrs prior to dosing [one drink is equal to one unit of alcohol (one glass wine, half pint beer, one measure of spirit)]
• Participation in any clinical trial within the past three months
• History of difficulty in donating blood or accessibility of veins in left or right arm
• Donation of blood (one unit or 350 ml) within three months prior to receiving the first dose of test material
• Use of any prescription drug therapy, with exception of any prescription medication administered at a stable dose for at least 6 weeks prior to Screening, provided the medication is not contraindicated by the metformin label
• Use of any alternate anti-diabetic therapy, except metformin, within three months of enrollment