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| Sponsor: | CombinatoRx |
|---|---|
| Information provided by: | CombinatoRx |
| ClinicalTrials.gov Identifier: | NCT00506298 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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. |
| 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 |
|---|---|
|
A: Experimental
CRx-401 (bezafibrate + diflunisal)
|
Drug: bezafibrate + diflunisal
bezafibrate + diflunisal
|
|
B: Active Comparator
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 |
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
Contacts and Locations| Canada, British Columbia | |
| Chilliwack, British Columbia, Canada | |
| Vancouver, British Columbia, Canada | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada | |
| Canada, Newfoundland and Labrador | |
| St. Johns, Newfoundland and Labrador, Canada | |
| Bay Roberts, Newfoundland and Labrador, Canada | |
| Holyroad, Newfoundland and Labrador, Canada | |
| Canada, Ontario | |
| Sudbury, Ontario, Canada | |
| Newmarket, Ontario, Canada | |
| Toronto, Ontario, Canada | |
| Aylmer, Ontario, Canada | |
| Sarnia, Ontario, Canada | |
| Corunna, Ontario, Canada | |
| London, Ontario, Canada | |
| Collingwood, Ontario, Canada | |
| Robarts Research Institute | |
| London, Ontario, Canada | |
| Burlington, Ontario, Canada | |
| Canada, Quebec | |
| Montreal, Quebec, Canada | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada | |
| Principal Investigator: | Tim Zmijowskyj, MD | Medicor Research Inc. |
More Information
| Responsible Party: | CombinatoRx ( Medical Monitor ) |
| Study ID Numbers: | CRx-401-001 |
| Study First Received: | July 20, 2007 |
| Last Updated: | May 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00506298 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Diabetes CRx-401 Bezafibrate |
Diflunisal Metformin plasma glucose |
|
Anti-Inflammatory Agents Antimetabolites Diflunisal Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors Pharmacologic Actions |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Diabetes Mellitus, Type 2 Bezafibrate Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Glucose Metabolism Disorders Central Nervous System Agents |