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

This study has been completed.
Sponsor:
Information provided by:
Zalicus
ClinicalTrials.gov Identifier:
NCT00506298
First received: July 20, 2007
Last updated: May 12, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: bezafibrate + diflunisal
Drug: bezafibrate + placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Zalicus:

Primary Outcome Measures:
  • The primary efficacy endpoint will measure change in fasting plasma glucose from Baseline to Day 90 [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Day 90 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: July 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
CRx-401 (bezafibrate + diflunisal)
Drug: bezafibrate + diflunisal
bezafibrate + diflunisal
Active Comparator: B
bezafibrate + placebo
Drug: bezafibrate + placebo
bezafibrate + placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00506298

Locations
Canada, British Columbia
Chilliwack, British Columbia, Canada
Vancouver, British Columbia, Canada
Canada, Manitoba
Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
Bay Roberts, Newfoundland and Labrador, Canada
Holyroad, Newfoundland and Labrador, Canada
St. Johns, Newfoundland and Labrador, Canada
Canada, Ontario
Aylmer, Ontario, Canada
Burlington, Ontario, Canada
Collingwood, Ontario, Canada
Corunna, Ontario, Canada
London, Ontario, Canada
Robarts Research Institute
London, Ontario, Canada
Newmarket, Ontario, Canada
Sarnia, Ontario, Canada
Sudbury, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Zalicus
Investigators
Principal Investigator: Tim Zmijowskyj, MD Medicor Research Inc.
  More Information

No publications provided

Responsible Party: Medical Monitor, CombinatoRx
ClinicalTrials.gov Identifier: NCT00506298     History of Changes
Other Study ID Numbers: CRx-401-001
Study First Received: July 20, 2007
Last Updated: May 12, 2009
Health Authority: Canada: Health Canada

Keywords provided by Zalicus:
Diabetes
CRx-401
Bezafibrate
Diflunisal
Metformin
plasma glucose

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bezafibrate
Diflunisal
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 19, 2014