A Clinical Study to Assess the Safety, Tolerability, and Activity of Oral SRT2104 Capsules Administered for 28 Days to Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized, placebo-controlled, parallel-group, double-blind, multiple-dose, activity and
      safety clinical study of SRT2104 administered orally once daily for 28 consecutive days. This
      will be an inpatient/outpatient study to assess the safety and pharmacokinetics of SRT2104 in
      type 2 diabetic male and female subjects on an existing, stable, background metformin
      therapy. Approximately 80 subjects will be enrolled. Subjects will be evenly randomized to
      receive SRT2104 2.0 g/day or placebo in the fed state.

      Subjects will be required to stay overnight at the study center on Days -2, -1, 0, 1
      (optional discharge at investigator's discretion), 27, 28, 41, and 42. During these
      admissions, pharmacokinetic, biomarker and glycated albumin samples will be collected, and
      glucose profiling, OGTT, glucose stabilization, hyperinsulinemc euglycemic clamp (HEGC)
      studies with indirect calorimetry and various other safety and activity procedures will be
      performed. On Day 1 of the study, subjects will be randomized to receive SRT2104 or placebo.
      Day 43 will be the last day of the study and subjects will be released. In addition, subjects
      will be asked to return to the study center on Day 14 for interim safety assessments.

      During the dosing period, study personnel will contact subjects by telephone on Days 7 and 21
      to conduct a safety assessment. Subjects will be required to monitor their fasting blood
      glucose and complete a daily diary for the outpatient portion of the study between Days 1 and
      28. A follow-up, safety phone call will occur 30 days following their final dose of SRT2104
      or placebo (Day 58 of the study) to identify any possible additional adverse events or
      concomitant medications.
    

Detailed description: 
      Randomized, placebo-controlled, parallel-group, double-blind, multiple-dose, activity and
      safety clinical study of SRT2104 administered orally once daily for 28 consecutive days. This
      will be an inpatient/outpatient study to assess the safety and pharmacokinetics (PK) of
      SRT2104 in type 2 diabetic (T2D) male and female subjects on an existing, stable, background
      metformin therapy. Approximately 112 subjects aged 18-65 years, who fulfill the
      inclusion/exclusion criteria, will be screened for this study to enroll approximately 80
      subjects. Subjects will be evenly randomized to receive SRT2104 2.0 g/day or placebo
      approximately 15 minutes following consumption of a standardized morning 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 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 pre-dosing phase of the study. On Day 1 of the study, subjects will be
      randomized to receive SRT2104 or placebo. Subjects will be required to stay overnight at the
      study center on Days -2, -1, 0, 1 (optional discharge at investigator's discretion), 27, 28,
      41, and 42 for testing, to assess safety, and to gather required biomarker samples. In
      addition, subjects will be asked to return to the study center on Day 14 for interim safety
      assessments. The subject will be telephoned on Days 7 and 21 to assess safety. Subjects will
      be required to monitor their fasting blood glucose and complete a daily diary for the
      outpatient portion of the study between Days 1 and 28. A follow-up, safety phone call will
      occur 30 days following their final dose of SRT2104 or placebo (Day 58 of the study) to
      identify any possible additional adverse events (AEs) or concomitant medications.
    

Intervention name(s): Placebo; SRT2104
Intervention type(s): Drug; Drug
Intervention description(s): For placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product.; SRT2104 will be supplied as hard gelatin capsules, with each containing 250mg SRT2104.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other