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Type 2 DiabetesPhase 2NCT00506298

Study of CRx-401 on Glucose Levels in Subjects With Type II Diabetes

A Phase 2 study testing bezafibrate + diflunisal in people with Type 2 Diabetes, run by Zalicus at 18 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
bezafibrate + diflunisal
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
18 sitesCanada
Study dates
Jul 2007to May 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must voluntarily give written informed consent
  • Must be between 18-75 years of age
  • Must have Type 2 diabetes for ≥ 6 months
  • HgbA1C between 7.0% and 9.5%
  • FPG > 6.7 mmol/L (120 mg/dL)
  • BMI: Lower limit of 27 kg/m2 and an upper Limit of 45 kg/m2
  • Treatment with a stable dosage for ≥ 8 weeks of either Glucophage metformin) ≥ 1000 and ≤ 2500 mg/day OR Glucophage XR ≤ 2000 mg/day
  • eGFR ≥ 70 mL/min

Who cannot join

  • History of any clinically significant atherosclerotic disorder including myocardial infarction (within 6 months of screening), angina, stroke, peripheral vascular disease or congestive heart failure
  • Known hypersensitivity or idiosyncratic reaction related to fibrates or NSAIDs including photo-allergic or phototoxic reactions to fibrates
  • Subjects in whom acute asthmatic attacks, urticaria, or rhinitis are precipitated by aspirin or other NSAIDs
  • History of clinically significant (as determined by the investigator cardiac, hematologic, hepatobiliary, peptic ulcer, renal, immunologic, metabolic, urologic, pulmonary, endocrinologic, neurologic, dermatologic, psychiatric, and/or other major disease
  • Type 1 Diabetes
  • Evidence of Cushing's syndrome, untreated hypothyroidism or other disorders that may lead to secondary weight gain, insulin resistance, or Type 2 diabetes
Show all 27Show fewer
  • Proliferative diabetic retinopathy or significant neuropathic symptoms that also limit activities of daily living
  • History of malignancy (except for treated or excised basal cell carcinoma)
  • Surgery within the 90 days prior to screening except for minor dental or cosmetic procedures
  • History of drug or alcohol abuse (as defined by the Investigator)
  • History of opportunistic infection
  • Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening
  • Fever or symptomatic viral or bacterial infection within 2 weeks prior to screening
  • Positive for HCV antibody
  • Positive for HBsAg
  • Known positive for HIV antibody
  • Pharmacologic treatment with statins, unless dosage has been stable ≥ three months and is unlikely to change over the course of the study.
  • Treatment with any concomitant medication that has not been at a stable dose for at least 28 days prior to screening.
  • Currently taking or planning to take during the trial:
  • Sulphonylureas, Injected hypoglycemic (exanatide or insulin), Weight loss medications, Thiazolidenediones, Glucocorticoids (inhaled glucocorticoids are permitted), Digoxin, Anticoagulants, Phenytoin, Loratadine, Erythromycin, MAO-inhibitors, NSAIDs (ASA ≤ 81 mg/d is permitted), COX-2 Inhibitors, Cholestryramine or fibrates, DPP-IV inhibitors, Any herbal medications unless reviewed with study doctor
  • Alanine aminotransferase ALT) or aspartate aminotransferase (AST laboratory values that exceed > 2.0 x upper limit of normal (ULN)
  • White blood cell (WBC) count < 4.0 x 109 /L or >14.0 X 109 /L
  • Hemoglobin < 105 g/L in females and < 110 g/L in males (< 10.5 g/dL in females and < 11.0 g/dL in males)
  • Participation in another clinical trial and/or treatment received with any investigational agent within 30 days before the initial dose of study medication
  • Female subject who is pregnant or lactating or of child bearing potential and not using acceptable methods of contraception (birth control pills, barriers or abstinence)
  • Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's return for follow-up visits on schedule
  • Other unspecified reasons that, in the opinion of the Investigator or sponsor make the subject unsuitable for enrollment

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Canada18 sites

  • Study site

    Aylmer, Ontario

  • Study site

    Bay Roberts, Newfoundland and Labrador

  • Study site

    Burlington, Ontario

  • Study site

    Chilliwack, British Columbia

  • Study site

    Collingwood, Ontario

  • Study site

    Corunna, Ontario

  • Study site

    Greater Sudbury, Ontario

  • Study site

    Holyroad, Newfoundland and Labrador

  • Robarts Research Institute

    London, Ontario

  • Study site

    London, Ontario

  • Study site

    Montreal, Quebec

  • Study site

    Newmarket, Ontario

  • Study site

    Sarnia, Ontario

  • Study site

    Saskatoon, Saskatchewan

  • Study site

    St. John's, Newfoundland and Labrador

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

  • Study site

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: 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.

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.

Conditions
Type 2 Diabetes
Being tested
bezafibrate + diflunisal, bezafibrate + placebo
Keywords
Diabetes, CRx-401, Bezafibrate, Diflunisal, Metformin, plasma glucose
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bezafibrate + diflunisalDrug

    bezafibrate + diflunisal

  • bezafibrate + placeboDrug

    bezafibrate + placebo

Study groups in NCT00506298
Study groupRoleWhat they receive
AExperimentalCRx-401 (bezafibrate + diflunisal)
Receives: Drug: bezafibrate + diflunisal
BActive comparatorbezafibrate + placebo
Receives: Drug: bezafibrate + placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy endpoint will measure change in fasting plasma glucose from Baseline to Day 90

    Measured: Day 90

Secondary outcomes (1)

  1. The exploratory efficacy endpoints will measure change in the following parameters: HOMA Index, HgbA1C, fructosamine, LDL, HDL, OGTT, triglycerides and total cholesterol from Baseline to Day 90

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionApr 2009
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00506298
Sponsor's protocol ID
CRx-401-001
Status last verified
May 2009
First submitted
20 Jul 2007
Last updated
13 May 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bezafibrate + diflunisal in people with Type 2 Diabetes, run by Zalicus at 18 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy endpoint will measure change in fasting plasma glucose from Baseline to Day 90 (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00506298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2009.

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