Study of CRx-401 on Glucose Levels in Subjects With Type II Diabetes
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
bezafibrate + diflunisal
bezafibrate + placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, CRx-401, Bezafibrate, Diflunisal, Metformin, plasma glucose
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
Sites / Locations
- Robarts Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
CRx-401 (bezafibrate + diflunisal)
bezafibrate + placebo
Outcomes
Primary Outcome Measures
The primary efficacy endpoint will measure change in fasting plasma glucose from Baseline to Day 90
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00506298
Brief Title
Study of CRx-401 on Glucose Levels in Subjects With Type II Diabetes
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Zalicus
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, CRx-401, Bezafibrate, Diflunisal, Metformin, plasma glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
CRx-401 (bezafibrate + diflunisal)
Arm Title
B
Arm Type
Active Comparator
Arm Description
bezafibrate + placebo
Intervention Type
Drug
Intervention Name(s)
bezafibrate + diflunisal
Intervention Description
bezafibrate + diflunisal
Intervention Type
Drug
Intervention Name(s)
bezafibrate + placebo
Intervention Description
bezafibrate + placebo
Primary Outcome Measure Information:
Title
The primary efficacy endpoint will measure change in fasting plasma glucose from Baseline to Day 90
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Zmijowskyj, MD
Organizational Affiliation
Medicor Research Inc.
Official's Role
Principal Investigator
Facility Information:
City
Chilliwack
State/Province
British Columbia
Country
Canada
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Winnipeg
State/Province
Manitoba
Country
Canada
City
Bay Roberts
State/Province
Newfoundland and Labrador
Country
Canada
City
Holyroad
State/Province
Newfoundland and Labrador
Country
Canada
City
St. Johns
State/Province
Newfoundland and Labrador
Country
Canada
City
Aylmer
State/Province
Ontario
Country
Canada
City
Burlington
State/Province
Ontario
Country
Canada
City
Collingwood
State/Province
Ontario
Country
Canada
City
Corunna
State/Province
Ontario
Country
Canada
Facility Name
Robarts Research Institute
City
London
State/Province
Ontario
Country
Canada
City
London
State/Province
Ontario
Country
Canada
City
Newmarket
State/Province
Ontario
Country
Canada
City
Sarnia
State/Province
Ontario
Country
Canada
City
Sudbury
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of CRx-401 on Glucose Levels in Subjects With Type II Diabetes
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