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NCT01018017

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

Completed Phase 2 Last updated 25 April 2017
What this trial tests

Phase 2 trial testing Placebo in Diabetes Mellitus, Type 2 in 86 participants. Completed in 25 December 2010.

Timeline
3 March 2010
Primary endpoint
25 December 2010
25 December 2010

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeother
Enrollment86
Start date3 March 2010
Primary completion25 December 2010
Estimated completion25 December 2010
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Slowing ageing by design: the rise of NAD<sup>+</sup> and sirtuin-activating compounds.
    Bonkowski MS, Sinclair DA. · · 2016 · cited 639× · PMID 27552971 · DOI 10.1038/nrm.2016.93
  2. Emerging roles of SIRT1 in fatty liver diseases.
    Ding RB, Bao J, Deng CX. · · 2017 · cited 275× · PMID 28808418 · DOI 10.7150/ijbs.19370
  3. Oxidative stress and epigenetic regulation in ageing and age-related diseases.
    Cencioni C, Spallotta F, Martelli F, Valente S, et al · · 2013 · cited 137× · PMID 23989608 · DOI 10.3390/ijms140917643
  4. Human Sirtuin Regulators: The "Success" Stories.
    Curry AM, White DS, Donu D, Cen Y. · · 2021 · cited 64× · PMID 34744791 · DOI 10.3389/fphys.2021.752117
  5. Frailty index as a biomarker of lifespan and healthspan: Focus on pharmacological interventions.
    Palliyaguru DL, Moats JM, Di Germanio C, Bernier M, et al · · 2019 · cited 59× · PMID 30926563 · DOI 10.1016/j.mad.2019.03.005
  6. Emerging roles of SIRT1 activator, SRT2104, in disease treatment.
    Chang N, Li J, Lin S, Zhang J, et al · · 2024 · cited 49× · PMID 38448466 · DOI 10.1038/s41598-024-55923-8
  7. Quantifying Competition among Mitochondrial Protein Acylation Events Induced by Ethanol Metabolism.
    Ali HR, Assiri MA, Harris PS, Michel CR, et al · · 2019 · cited 21× · PMID 30644754 · DOI 10.1021/acs.jproteome.8b00800
  8. The Endothelium as a Target for Anti-Atherogenic Therapy: A Focus on the Epigenetic Enzymes EZH2 and SIRT1.
    Fledderus J, Vanchin B, Rots MG, Krenning G. · · 2021 · cited 19× · PMID 33562658 · DOI 10.3390/jpm11020103

Verify or expand the search:

Other trials of SRT2104

Trials testing the same drug.

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

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Data sources for this page

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