NCT00506298

A Randomized, Multi-Center Study to Compare the Effects of CRx-401 to Bezafibrate Plus Placebo on Plasma Glucose Levels When Given to Subjects With Type II Diabetes on Metformin.

Completed Phase 2 Last updated 12 May 2009

What this trial tests

Phase 2 trial testing bezafibrate + diflunisal in Type 2 Diabetes in 150 participants. Completed in 1 May 2009.

Timeline

1 July 2007

Primary endpoint
1 April 2009

1 May 2009

Quick facts

Lead sponsor	Zalicus
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	150
Start date	1 July 2007
Primary completion	1 April 2009
Estimated completion	1 May 2009
Sites	18 locations across Canada

Drugs / interventions tested

• bezafibrate + diflunisal — full drug profile →
• bezafibrate + placebo

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

Zalicus — full company profile →

Who can join

Adults 18 to 70, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The primary efficacy endpoint will measure change in fasting plasma glucose from Baseline to Day 90
  Time frame: Day 90

Sponsor's own description

This trial will assess the efficacy of CRx-401 in lowering FPG levels in patients taking metformin to treat their diabetes. In addition, this initial trial will evaluate insulin resistance (HOMA-IR index), HgbA1c levels, glycated protein, LDL, HDL, triglycerides, and total cholesterol, as well as the safety of CRx-401.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Drug repositioning for diabetes based on 'omics' data mining.
   Zhang M, Luo H, Xi Z, Rogaeva E. · · 2015 · cited 49× · PMID 25946000 · DOI 10.1371/journal.pone.0126082