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CLINICAL TRIALS IN THE GREATER TORONTO AREA
The BBDC posts information regarding clinical research trials relevant to diabetes and it's
complications ongoing at the University of Toronto and its affiliated
hospitals. This information is intended to be a resource both for patients interested in participating in clinical trials in the Greater Toronto Area, and for research professionals.
What is a Clinical Trial?
Clinical trials are research studies in which new treatments [i.e. drugs, diagnostics, procedures, vaccines, and other therapies] are tested in people to see if they are safe and
effective.
Some Questions to Ask Before You Participate in a Clinical Trial:
- What is the study about?
- Who is conducting the study? Who is paying for it?
- How long is the study expected to last?
- What opportunities will I have to offer feedback during the study?
- What benefits can I hope to receive?
- What are the risks or possible side effects?
- Will there be compensation? How?
- What follow up will I receive?
- How will I be protected?
Make sure you discuss the answers with your loved ones and your primary health care provider before agreeing to participate in any research study. Follow the study protocol religiously, and let your physician know what's going on so that you can both be aware of any possible side effects or drug interactions with medications you may already be taking.
For additional information regarding clinical trials and clinical trial listings
in Canada and the United States, please view the following websites: myhealthCANADA
, The National Institutes of Health, and CenterWatch.
The clinical trial information listed below has been provided by
the University of Toronto diabetes research faculty
who are involved in the studies. The clinical trials have been reviewed and approved by Health Canada and/or the
institution's Research Ethics Review Boards. The Banting and Best Diabetes Centre is not involved in the clinical trials in any way.
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| Name of Trial |
The
BEST Study (The Beta-Cell Evaluation and Sitagliptin
Trial) |
| Location |
Toronto
(Leadership Sinai Centre for Diabetes,
Mount Sinai
Hospital
)
|
| Primary Investigator |
Dr.
Bernard Zinman and Dr. Ravi Retnakaran |
| Supporting Centre |
Merck
Frosst Canada Ltd. |
| Start and End Dates of Trial |
Start: 2007
End: 2009 |
| Objective of Trial |
To
compare the preservation of beta-cell function in patients with type 2
diabetes mellitus (T2DM) treated with (i) sitagliptin and metformin
versus (ii) placebo and metformin, for 1 year.
|
| Description of Trial |
BEST is a 14-month, single-centre, double-blind randomized controlled
clinical trial in which patients with type 2 diabetes mellitus are
randomized to either (i) metformin and sitagliptin or (ii) metformin
and placebo. Studies have shown that sitagliptin may help to preserve
beta-cell function in patients with T2DM.
A total of 40 patients will be followed for 1
year. Active treatment with Metformin 1000 mg administered twice daily
and Sitagliptin 100mg once daily will be compared to treatment with
Metformin 1000 mg twice daily and Sitagliptin/Placebo 100mg once
daily. The study participants will receive follow-up phone calls at
two, four weeks and intermittently after randomization, and make
clinic visits at baseline, 6 weeks and every three months for the
duration of the study.
The
primary outcome is to determine whether Sitagliptin can prevent the
progressive deterioration of pancreatic beta-cell function that is
responsible for the worsening of T2DM over time. Secondary outcomes
include time to loss of glycemic control, changes in lipids and
cardiovascular risk factors, and fasting blood glucose at 1 year.
|
| Patient Recruitment Criteria |
Inclusion criteria:
-
Patients with type 2 diabetes aged
30-75 inclusive
-
Taking either no diabetes medication
OR taking 1 or 2 oral anti-diabetic agents
- A1c between 6.0 % and 9.0 % inclusive
Exclusion
Criteria:
-
Current use of
insulin therapy
-
Involvement in
any other study requiring drug therapy
-
History of
active liver or renal disease
-
History of
uncontrolled hypertension or serious cardiac arrhythmias
-
HIV, Hepatitis
B/C or tuberculosis infection
-
Any major
illness with a life expectancy of <5 years or that may
interfere with the patient's participation in the study
-
Excessive
alcohol consumption
- Pregnancy or unwillingness to use reliable contraception.
|
| Patient Reimbursement |
Reimbursement
offered for parking or transit costs. |
| Contact Information |
Christine Opsteen
Phone: 416-586-4800 Ext. 2621
|
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| Name of Trial |
Oral Insulin For Prevention of Diabetes in
Relatives at Risk for Type 1 Diabetes Mellitus
|
| Location |
The
Hospital for Sick Children
|
| Primary Investigator |
Dr.
Diane Wherrett
|
| Supporting Centre |
National
Institute
of
Health
|
| Start and End Dates of Trial |
Start Date:
August 2007
End Date: until closed to enrollment
|
| Objective of Trial |
The primary objective of the TrialNet
Oral Insulin Trial is to determine if treatment with
oral insulin, will
prevent or delay the development of clinical Type 1 Diabetes Mellitus
(T1DM) in non-diabetic relatives of patients with T1DM who have
insulin autoantibodies but who do not have abnormal blood sugars. This
intervention will be compared with a placebo given in a double-masked
fashion.
|
| Description of Trial |
The primary objective is to determine
whether treatment with oral insulin will prevent or delay the
development of clinical Type 1 Diabetes Mellitus (T1DM) in subjects at
risk for T1DM. The study
is a 2-arm, multicenter, randomized, double-masked, placebo-controlled
clinical trial. Subjects will receive 7.5 mg of recombinant human
insulin crystals or placebo in capsules.
The primary outcome is the development of diabetes among
subjects who are shown to be at risk for T1DM due to the presence of
insulin autoantibodies. The diagnosis of diabetes is as defined
by the American Diabetes Association (ADA).
Basic entry criteria for study
participants includes: (1)
Relatives of people with T1DM with insulin antibodies (mIAA) and at
least one other diabetes autoantibody present and (2) have a
normal blood glucose levels during and oral glucose tolerance test
performed within 7 weeks prior to randomization. This study will
provide a information of the effects of oral insulin therapy in
subjects with different T1DM risk profiles and will give us an idea of
whether or not this treatment is effective.
|
| Patient Recruitment Criteria |
Inclusion Criteria:
- Have a proband with T1DM.
- If the proband is a sibling or a
child, the study participant must be 3 - 45 years of age. If
the proband is a second or third degree relative (i.e. Niece,
Nephew, Aunt, Uncle, Grandchild, Cousin),
the study participant must be 3-20 years of age.
- Willing to sign Informed Consent
Form.
- OGTT performed within 7 weeks
prior to randomization in which:
a) fasting plasma glucose < 110 mg/dL (6.1 mmol/l), and
b) 2 hour plasma glucose < 140 mg/dL (7.8 mmol/l)
- mIAA confirmed positive within
the previous six months.
- Two samples with at least one
autoantibody other than mIAA positive within the previous six
months.
|
| Patient Reimbursement |
None |
| Contact Information |
Dr. Diane Wherrett (Principal Investigator)
Lesley Eisel (Research Nurse)
Hospital for Sick Children
Phone: 416-813-7654 Ext. 1798 or Toll-free 1-866-699-1899
E-mail: lesley.eisel@sickkids.ca
Angela
Roode (Research Nurse)
Hospital for Sick Children
Phone: 416-813-5858 or Toll-free 1-866-699-1899
E-mail: angela.roode@sickkids.ca |
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| Name of Trial |
The
Type 1 Diabetes Genetics Consortium Study – TRIOS study
|
| Location |
The
Hospital for Sick Children
|
| Primary Investigator |
Dr.
Diane Wherrett
|
| Supporting Centre |
National
Institute
of
Health
|
| Start and End Dates of Trial |
Start
Date: January 2006
End Date: August 2008
|
| Objective of Trial |
The
ultimate objective of the study is to provide the genetic and clinical
resources necessary to achieve a significant sample size for type 1
diabetes gene identification. The goal of the Type 1 Diabetes Genetics
Consortium (T1DGC) is to organize international efforts to identify
genes that will tell us more about an individual’s risk of type 1
diabetes (T1D).
|
| Description of Trial |
Our ability to accurately identify
genes associated with the risk of developing T1D has been complicated
by the very small amount of family genetic material that has been
collected to date. The T1DGC plans to recruit low prevalence trio
families in the North American Network.
A trio family is defined as an affected offspring plus both
biological parents (i.e. proband, mother and father).
Trios will be collected only in those populations where the
prevalence of type 1 diabetes is low.
Therefore the trio collections will focus on Mexican-and
African Americans/Canadians. Information
on the trios from low prevalence populations will aid the T1DGC in the
fine mapping of HLA and non-HLA linked regions, and in the rapid
evaluation of published reports of genetic associations.
|
| Patient Recruitment Criteria |
African
Canadian or Mexican Canadian families with children who have been
diagnosed with Type 1 Diabetes
|
| Patient Reimbursement |
None |
| Contact Information |
Dr. Diane Wherrett (Principal
Investigator)
Lesley Eisel (Research Nurse)
Hospital for Sick Children
Phone: 416-813-7654 Ext. 1798 or toll-free 1-866-699-1899
E-mail: lesley.eisel@sickkids.ca
Natasha Razack (Project Manager)
Hospital for Sick Children
Phone: 416-813-5858 or toll-free 1-866-699-1899
E-mail: natasha.razack@sickkids.ca
|
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| Name of Trial |
Sight-Threatening
Retinal Complications in Type 2 Diabetes
|
| Location |
Toronto Western Hospital
|
| Primary Investigator |
Dr.
Chris Hudson, PhD, MCOptom, FAAO
This study has received the ethical approval of both the University
Health Network Research Ethics Board and the University of Waterloo
Office of Research Ethics.
|
| Supporting Centre |
Canadian Institutes of Health Research (CIHR)
|
| Start and End Dates of Trial |
Start: September
2005
End:
August 2010 |
| Objective of Trial |
Diabetic maculopathy (DM) is the most common cause of vision loss in
people with type 2 diabetes. DM is characterized by the leaking and
collapse of blood vessels at the back of the eye (the retina). DM
remains the most common sight-threatening complication of diabetes.
Many aspects of the presentation and characteristics of development of
early DM are poorly understood, while one distinct form termed
“ischemic maculopathy” is untreatable. This study will investigate
longitudinal change of ocular predictive factors in patients with
developing DM. In particular, we will correlate retinal arteriolar
vascular reactivity with biochemical markers of endothelial
dysfunction in patients with a propensity for the development of DM.
The study will investigate currently undefined aspects of the
presentation, characteristics of progression and pathogenesis of DM in
patients with a propensity for the development of the disease using a
longitudinal study design. It will result in earlier treatment, new
treatment options and, ultimately, tangible improvements in the
outcome of treatment of DM.
|
| Description of Trial |
Visits will be repeated every 6 months for a period of 3 years for
diabetic patients and for a period of 1 year for healthy controls.
Volunteers will undergo clinical assessment, retinal imaging using
non-invasive specialized cameras, assessment of retinal vascular
reactivity (i.e. retinal vessel response to inhaled oxygen) and blood
testing (to determine markers of endothelial function; E-selectin,
ICAM-1 and VCAM-1; and blood sodium
and creatinine, microalbuminuria, serum albumin, hs-CRP & A1c). Volunteers will receive an initial baseline
assessment to establish eligibility, ocular classification and general
health profile. Each visit will be of approx 2 hours duration.
|
| Patient Recruitment Criteria |
Inclusion Criteria:
-
Age
range of 35-75yrs.
-
Visual
acuity of 20/40) or better.
-
Type
2 diabetes (and healthy age-matched controls)
Exclusion
Criteria:
-
Distance
refractive error > ±6.00DS & / or ±2.50DC.
-
Any
other eye disease or disorder including lenticular opacity or
ocular surgery.
-
Habitual smoking.
-
Lung disease.
-
Proliferative diabetic retinopathy.
|
| Patient Reimbursement |
Your transportation expenses incurred as a result
of participation in the study will be covered up to a maximum of $20
per visit.
|
| Contact Information |
Retina Research Group - Tien Wong (Lab
Coordinator)
399 Bathurst Street, Main Pavilion 6-206
Toronto, Ontario M5T 2S8
Phone: (416) 603-5694
Fax: (416) 603-5126
E-Mail: twong@uhnres.utoronto.ca
|
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| Name of Trial |
The Effect of Treatment with HMG-CoA Reductase
Inhibitors (Statins) on Retinal Blood Flow in Hypercholesterolemic
Patients |
| Location |
Toronto
Western
Hospital
|
| Primary Investigator |
Dr. Chris Hudson
, PhD, MCOptom, FAAO
This study has received the ethical approval of both the University
Health Network Research Ethics Board and the
University
of
Waterloo Office
of Research Ethics. |
| Supporting Centre |
Pfizer
Canada Inc. |
| Start and End Dates of Trial |
Start: October 2006
End: October 2007 |
| Objective of Trial |
The
aim of the study is to determine whether the initiation of treatment
with Lipitor (atorvastatin), a cholesterol-lowering medication, will
influence retinal blood flow in patients with elevated cholesterol.
The correlation between change in retinal blood flow and change
in serum lipid parameters will be examined.
|
| Description of Trial |
Retinal blood flow will be non-invasively measured over a period of six months, with the
first assessment taking place prior to initiation of statin
treatment. After the
initial appointment, patients will commence Lipitor treatment, at the
dosage prescribed by their physician.
At each visit, retinal vessel images will be acquired while the
patient is breathing air and then elevated oxygen through a breathing
mask. Completion of the study requires six study visits, each lasting
approximately 90 minutes.
- Six study visits, each lasting approximately 90 minutes (Healthy
controls will attend for 2 visits).
- Food and beverage diary recorded on the day before each visit.
- Avoid caffeine and nasal decongestants, and will be asked to
fast for 8hrs (i.e. over night) prior to visit.
- Patients will be asked to wear a breathing mask to permit the
delivery of air and elevated oxygen.
- Images of retinal vessels will be non-invasively acquired at
each visit.
- Blood tests to measure cholesterol, blood glucose and cytokines
will also be taken.
|
| Patient Recruitment Criteria |
We are seeking patients who:
- Have elevated blood cholesterol
- Have been prescribed Lipitor by their doctor
- Have visual acuity of 20/20 or better
- Are 20 years of age or older
Exclusion Criteria:
- Refractive error >+/- 6.00 DS and/or +/- 2.50 DC
- Any eye disease
- History of eye surgery
- Current smokers (or those who have ceased smoking for < 6
months)
- Acute liver disease
- Nursing or pregnant women
- Systemic disease including respiratory disorders, and heart or
cardiovascular disease
|
| Patient Reimbursement |
Pfizer will provide the patient with Lipitor at
the dose specified by their physician for the duration of their
participation in the study. Patients will receive remuneration for
each of their visits to the lab to cover travel expenses. |
| Contact Information |
Retina Research Group
399 Bathurst Street Main Pavilion 6-206
Toronto
,
Ontario
,
M5T 2S8
Phone: (416) 603-5694
Fax: (416) 603-5126
E-Mail: twong@uhnres.utoronto.ca |
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| Name of Trial |
The
CANOE Study
(CAnadian
Normoglycemia Outcomes Evaluation Study) |
| Location |
Toronto
(Leadership Sinai Centre for Diabetes, Mount Sinai Hospital); London
(University of Western Ontario Centre for Research in Family Medicine) |
| Primary Investigator |
Dr. Bernard Zinman |
| Supporting Centre |
GlaxoSmithKline |
| Start and End Dates of Trial |
Start: 2004
End: 2009 |
| Objective of Trial |
-
To determine whether treatment with
Avandamet, in addition to a healthy living lifestyle program, will
prevent the development of Type 2 diabetes in subjects with
impaired glucose tolerance (IGT).
- To
determine whether treatment with Avandamet, in addition to a
healthy living lifestyle program, will improve risk factors for
cardiovascular disease and diabetes.
|
| Description of Trial |
CANOE
is a randomized, double-blind controlled trial to determine whether
Avandamet will decrease the development of diabetes in individuals
with IGT (a condition indicating high diabetes risk).
A total of 200 patients will be followed for an average follow
up of 4 years (range 3 – 5 years). Active treatment with
Avandamet (Metformin 500 mg / Avandia 2 mg) administered twice daily
will be compared to matched placebo.
All study participants will receive a lifestyle intervention
program based on the latest evidence-based guidelines recommended by
the Canadian Diabetes Association.
The study participants will receive a follow-up phone call two
weeks after randomization and make clinic visits every two months
thereafter for the first year.
They will then be seen every six months for the duration of the
study.
The primary outcome is the development of new onset diabetes.
Secondary outcomes include markers of diabetes and
cardiovascular risk.
|
| Patient Recruitment Criteria |
Inclusion Criteria:
Exclusion Criteria:
-
Current use of Metformin or Rosiglitazone
-
Prior use of
medication to treat diabetes with the exception of during
gestational diabetes
-
Use of drugs known to
worsen glucose tolerance (e.g. systemic glucocorticoids, thiazide
diuretics, or niacin)
-
History of
diabetes, except gestational diabetes
-
Active liver or
kidney disease or anemia
-
Any major illness
with a life expectancy of <5 years or that may interfere with
the patient's participation in the study
-
Involvement in any
other study requiring drug therapy
-
History of congestive
heart failure or current congestive heart failure
-
Excessive alcohol
consumption
-
Pregnancy or
unwillingness to use reliable contraception.
|
| Patient Reimbursement |
Reimbursement
offered for parking or transit costs. |
| Contact Information |
Jan
Neuman
Phone: 416-586-4800 ext 3924 E-mail: JNeuman@mtsinai.on.ca
OR
Dr. Bernard Zinman
Phone: 416-586-8747 E-mail: zinman@mshri.on.ca
Leadership Sinai Centre for Diabetes
Mount Sinai Hospital
Lebovic
Building, 5th Floor
60 Murray Street
Toronto, Ontario M5G 1X5 |
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| Name of Trial |
The Natural History of the Development of Type 1
Diabetes Study |
| Location |
The Hospital For Sick Children |
| Primary Investigator |
Dr. Diane Wherrett |
| Supporting Centre |
National Institutes of Health |
| Start and End Dates of Trial |
Start: June 2004
End: Summer 2009 |
| Objective of Trial |
The aim of the project is to follow individuals at
risk for type 1 diabetes (T1D) over time by testing for specific
autoantibodies associated with type 1 diabetes and assessing their
ability to produce insulin. The metabolic and
immunologic status of individuals at risk for T1D will be monitored. |
| Description of Trial |
Prospective cohort design. Screening,
baseline, repeat assessments will assess metabolic & immunologic
status over time. Relatives
of people with type 1 diabetes will be screened to determine if they
are at risk for the development of type 1 diabetes. Screening
involves a blood test for diabetes related antibodies. If
antibodies are not present, individuals under 18 will be offered to be
screened again on a yearly
basis to discover if they develop the antibodies in question.
If antibodies are present, further testing will be offered to
determine individuals' risk of developing diabetes at a baseline risk
assessment visit. Antibody-positive subjects will be followed
every 6 months to learn how their immune response changes and if they
are developing diabetes. |
| Patient Recruitment Criteria |
Blood relatives of individuals with T1D and
between the age of 1-45 years will be invited to be screened.
Inclusion Criteria:
- Willing to give informed consent
- 1 to 45 years
- Have a blood relative with T1D (primarily 1st degree, but those
<=20 with 2nd or 3rd degree relatives are eligible)
- DPT-1 (predecessor trial) subjects will be entered into
appropriate phase of study
Exclusion Criteria:
- History of insulin treatment or oral hypoglycemic agents
- Have diabetes (1997 ADA criteria)
- Have known severe active diseases
- Unable to comply with protocol
|
| Patient Reimbursement |
No reimbursement offered (for screening). |
| Contact Information |
Dr. Diane Wherrett (Principal Investigator)
Lesley Eisel (Research Nurse) Hospital for Sick Children
Phone: 416-813-7654 Ext. 1798 or toll-free 1-866-699-1899
Email: lesley.eisel@sickkids.ca
Natasha Razack (Project Manager)
Hospital for Sick Children
PhoneL 416-813-5858 or toll-free 1-866-699-1899
Email: natasha.razack@sickkids.ca
|
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| Name of Trial |
BARI 2D |
| Location |
Toronto General Hospital |
| Primary Investigator |
Dr. George Steiner & Dr. Leanard Schwartz |
| Supporting Centre |
NIH |
| Start and End Dates of Trial |
Start: April 2001
End: 2008 |
| Objective of Trial |
To determine in type 2 diabetes whether in those with coronary disease who could be managed by intensive cardiovascular medical therapy, there is a difference in outcome if: A) medical vs. interventional therapy is used & B) insulin sensitizing (metformin &/or TZD) vs. insulin providing (insulin or sulfonylurea is used. |
| Description of Trial |
2x2 randomized design. 2 years for recruitment and 5 years for follow-up. |
| Patient Recruitment Criteria |
Men & women with type 2 diabetes & with coronary artery disease that would be amendable to either intensive medical management or intervention (PTCA or CABG). |
| Patient Reimbursement |
For expenses |
| Contact Information |
Dr. George Steiner
Tel: 416-340-4538 Fax: 416-340-3473
E-mail: george.steiner@uhn.on.ca
or
Dr. Leonard Schwartz
Tel: 416-340-3933 Fax: 416-595-6441
E-mail: leonard.schwartz@uhn.on.ca
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