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

NCT00937326 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2018-07-13

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

SRT2104

SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg.

DRUG

Placebo

Placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Sirtris, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-19
Primary Completion
2010-09-18
Completion
2010-09-18

Countries

  • Bulgaria
  • Estonia
  • Hungary
  • Poland
  • Romania
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00937326 on ClinicalTrials.gov