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

NCT00506298 | Completed Phase 2

• 1 other identifier: CRx-401-001
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 18

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

Keywords

Diabetes; CRx-401; Bezafibrate; Diflunisal; Metformin; plasma glucose

Outcome Measures

Primary Outcomes (1)

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

  Day 90

Secondary Outcomes (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

  Day 90

Study Arms (2)

A

EXPERIMENTAL

CRx-401 (bezafibrate + diflunisal)

Drug: bezafibrate + diflunisal

B

ACTIVE COMPARATOR

bezafibrate + placebo

Drug: bezafibrate + placebo

Interventions

bezafibrate + diflunisal DRUG

bezafibrate + diflunisal

A

bezafibrate + placebo DRUG

bezafibrate + placebo

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zalicus: lead

Study Sites (18)

Unknown Facility

Chilliwack, British Columbia, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Winnipeg, Manitoba, Canada

Location

Unknown Facility

Bay Roberts, Newfoundland and Labrador, Canada

Location

Unknown Facility

Holyroad, Newfoundland and Labrador, Canada

Location

Unknown Facility

St. John's, Newfoundland and Labrador, Canada

Location

Unknown Facility

Aylmer, Ontario, Canada

Location

Unknown Facility

Burlington, Ontario, Canada

Location

Unknown Facility

Collingwood, Ontario, Canada

Location

Unknown Facility

Corunna, Ontario, Canada

Location

Unknown Facility

Greater Sudbury, Ontario, Canada

Location

Robarts Research Institute

London, Ontario, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Newmarket, Ontario, Canada

Location

Unknown Facility

Sarnia, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Saskatoon, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Bezafibrate; Diflunisal

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzoates; Acids, Carbocyclic; Chlorobenzoates; Phenyl Ethers; Ethers; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Salicylates; Hydroxybenzoates

Study Officials

• Tim Zmijowskyj, MD

  Medicor Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 20, 2007
• First Posted: July 25, 2007
• Study Start: July 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 13, 2009

Record last verified: 2009-05

Locations

CA (18)