Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Type 2 Diabetic Human Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine the safety and tolerability of SRT2104
      (0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for
      28 consecutive days, and to characterize the pharmacokinetic profile of SRT2104 after a
      single dose and multiple administrations in type 2 diabetic subjects.

      The secondary purpose of this study is to determine the effect of SRT2104 (0.25, 0.5, 1.0,
      and 2.0 g/day) when administered once daily for 28 consecutive days on fasting blood glucose
      and insulin and post-prandial blood glucose and insulin in type 2 diabetic subjects.
    

Detailed description: 
      Study Objectives

      Primary:

        1. To determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) in
           type 2 diabetic subjects when administered once daily for 28 consecutive days.

        2. To characterize the pharmacokinetic profile of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day)
           after a single dose and multiple administrations in type 2 diabetic subjects.

      Secondary:

      1. To determine the effect of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) when administered once
      daily for 28 consecutive days on fasting blood glucose and insulin and post-prandial blood
      glucose and insulin in type 2 diabetic subjects.

      Study Design:

      Prospective, multi-center, clinical study of SRT2104 administered orally once daily for 28
      consecutive days; randomized, placebo-controlled, double-blind, multiple-dose,
      inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of SRT2104 in type
      2 diabetic male and female subjects on an existing, stable, background metformin therapy.
      Approximately 225 subjects aged 30-70, who fulfill the inclusion/exclusion criteria, will be
      enrolled in this study to ensure completion of forty (40) evaluable subjects within each of
      five dosing groups. Subjects will be evenly randomized to receive SRT2104 at one of five
      doses, placebo (A), 0.25 g/day (B), 0.5 g/day (C), 1.0 g/day (D), or 2.0 g/day (E), once a
      day for 28 consecutive days, approximately 15 minutes following consumption of a standardized
      meal. Subjects will remain on a fixed dose of test material for all dosing days in the study.

      Subjects will sign the informed consent form at the Screening Visit, and will undergo
      screening assessments over a 2-day period to verify eligibility for the study. If eligible
      and willing to participate, subjects will return to the clinic within 21 days of the
      Screening Visit to participate in the dosing phase of the study. Subjects will be randomized
      to receive SRT2104 or placebo, and will be required to stay overnight at the study center on
      Day -1 and Day 27 to gather required PK samples and to assess safety on Day 1 and Day 28
      respectively. In addition, subjects will be asked to return to the study center on Days 2 and
      29; for three interim weekly safety assessments (on Days 8, 15, 22); and for an End of Study
      safety assessment 7 days after they complete the 28-day dosing period. A follow-up safety
      call will be made to each subject 30 days following their final dose of SRT2104 or placebo.
    

Intervention name(s): SRT2104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg.; Placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment