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

Sponsor

Zalicus (Industry)

Overall Status

Completed

CT.gov ID

NCT00506298

Collaborator

(none)

150

Enrollment

Locations

Arms

Duration (Months)

8.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Drug: bezafibrate + diflunisal Drug: bezafibrate + placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Apr 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A CRx-401 (bezafibrate + diflunisal)	Drug: bezafibrate + diflunisal bezafibrate + diflunisal
Active Comparator: B bezafibrate + placebo	Drug: bezafibrate + placebo bezafibrate + placebo

Arm

Intervention/Treatment

Experimental: A

CRx-401 (bezafibrate + diflunisal)

Drug: bezafibrate + diflunisal

bezafibrate + diflunisal

Active Comparator: B

bezafibrate + placebo

Drug: bezafibrate + placebo

bezafibrate + placebo

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1		Chilliwack	British Columbia	Canada
2		Vancouver	British Columbia	Canada
3		Winnipeg	Manitoba	Canada
4		Bay Roberts	Newfoundland and Labrador	Canada
5		Holyroad	Newfoundland and Labrador	Canada
6		St. Johns	Newfoundland and Labrador	Canada
7		Aylmer	Ontario	Canada
8		Burlington	Ontario	Canada
9		Collingwood	Ontario	Canada
10		Corunna	Ontario	Canada
11	Robarts Research Institute	London	Ontario	Canada
12		London	Ontario	Canada
13		Newmarket	Ontario	Canada
14		Sarnia	Ontario	Canada
15		Sudbury	Ontario	Canada
16		Toronto	Ontario	Canada
17		Montreal	Quebec	Canada
18		Saskatoon	Saskatchewan	Canada