Clinical trial NCT00506298: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes
Keywords: Diabetes
CRx-401
Bezafibrate
Diflunisal
Metformin
plasma glucose
Lead sponsor: Zalicus
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The primary efficacy endpoint will measure change in fasting plasma glucose from Baseline to Day 90
timeFrame: Day 90
Secondary outcomes:
measure: 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
timeFrame: Day 90
Other outcomes:
Locations:
city: Chilliwack
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Bay Roberts
country: Canada
state: Newfoundland and Labrador
city: Holyroad
country: Canada
state: Newfoundland and Labrador
city: St. Johns
country: Canada
state: Newfoundland and Labrador
city: Aylmer
country: Canada
state: Ontario
city: Burlington
country: Canada
state: Ontario
city: Collingwood
country: Canada
state: Ontario
city: Corunna
country: Canada
state: Ontario
city: London
country: Canada
facility: Robarts Research Institute
state: Ontario
city: London
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
affiliation: Medicor Research Inc.
name: Tim Zmijowskyj, MD
role: PRINCIPAL_INVESTIGATOR
References: