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

NCT ID: NCT00506298

Last Updated: 2009-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-05-31

Brief 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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

CRx-401 (bezafibrate + diflunisal)

Group Type: EXPERIMENTAL

bezafibrate + diflunisal

Intervention Type: DRUG

bezafibrate + diflunisal

B

bezafibrate + placebo

Group Type: ACTIVE_COMPARATOR

bezafibrate + placebo

Intervention Type: DRUG

bezafibrate + placebo

Interventions

bezafibrate + diflunisal

bezafibrate + diflunisal

Intervention Type: DRUG

bezafibrate + placebo

bezafibrate + placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zalicus

INDUSTRY

Sponsor Role: lead

Responsible Party

CombinatoRx

Principal Investigators

Tim Zmijowskyj, MD

Role: PRINCIPAL_INVESTIGATOR

Medicor Research Inc.

Locations

Chilliwack, British Columbia, Canada

Vancouver, British Columbia, Canada

Winnipeg, Manitoba, Canada

Bay Roberts, Newfoundland and Labrador, Canada

Holyroad, Newfoundland and Labrador, Canada

St. John's, Newfoundland and Labrador, Canada

Aylmer, Ontario, Canada

Burlington, Ontario, Canada

Collingwood, Ontario, Canada

Corunna, Ontario, Canada

Greater Sudbury, Ontario, Canada

Robarts Research Institute

London, Ontario, Canada

London, Ontario, Canada

Newmarket, Ontario, Canada

Sarnia, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

CRx-401-001

Identifier Type: -

Identifier Source: org_study_id