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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | CRx-401 (bezafibrate + diflunisal) |
|
| B | Active Comparator | bezafibrate + placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bezafibrate + diflunisal | Drug | bezafibrate + diflunisal |
| |
| bezafibrate + placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint will measure change in fasting plasma glucose from Baseline to Day 90 | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Tim Zmijowskyj, MD | Medicor Research Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chilliwack | British Columbia | Canada | ||||
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001629 | Bezafibrate |
| D004061 | Diflunisal |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D058607 | Fibric Acids |
| D058610 |
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| Drug |
bezafibrate + placebo |
|
| 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 |
| Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002723 | Chlorobenzoates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |