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Clinical Trials

Clinical Trials in the Greater Toronto Area

The BBDC posts information regarding clinical research trials relevant to diabetes and its 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 web sites: 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 & Best Diabetes Centre is not involved in the clinical trials in any way.

Name of Trial TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with T2DM and Inadequate Glycemic Control on Mono or Dual Combination Oral Antihyperglycemic Therapy
Location Mount Sinai Hospital, Toronto, Ontario
Primary Investigator Dr. Bernard Zinman
Supporting Centre Merck and Co., Inc 
Start and End Dates of Trial Start: May 2010 
Estimated recruitment end:  December 2011
Estimated Trial End: 2015.  Until 1,300 confirmed CV events in the primary composite endpoint occur and 36 months or more have elapsed from the time that 2,000 patients on a baseline of metformin monotherpay and 2,000 patients on a baseline of pioglitazone (either mono or combination therapy) which is anticipated to provide approximately 4-5 yrs of patient follow-up.
Objective of Trial To compare the impact of including sitagliptin as part of usual care vs. usual care without sitagliptin on CV outcomes as measured by the primary CV composite endpoint of DV related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization. 
Description of Trial This study will enrol approximately 14,000 patients over an estimated two years, with an estimated follow-up of at least four years or until enough CV events are accumulated.

This study will blend a combination of study visits with visits to subjects’ usual care providers.  In the event that a participant receives their usual diabetes care through a provider at a facility other than the study site there will be a minimum of two visits per year to the subjects’ usual care providers in addition to the study visits.  Investigators will provide blinded study medication to participants. However, primary management of the patients’ diabetes and other metabolic conditions such as hypertension and dyslipidemia will be deferred to their usual health care providers, whether located at the study site or elsewhere.  While the study investigators will monitor each patient’s clinical status (in particular, HbA1c and occurrence of CV events) through follow-up visits every six months interspersed with two telephone calls per year, all medication adjustments except blinded study drug will be made by the subjects’ usual healthcare providers.  This will include providing diet and exercise counselling and targeting appropriate glycemic control and other cardiovascular risk factors.  The study investigator will be responsible for dose adjustments of blinded study drug.  Therefore, this trial will depend upon a carefully constructed monitoring and communication system.
Patient Recruitment Criteria

Key Inclusion Criteria:

  • Male or female, Type 2 Diabetes Mellitus, ≥50 yrs of age receiving metformin, pioglitazone, or sulfonylurea as monotherapy or any dual combination of metformin, pioglitazone, or sulfonylurea for at least 3 months without dose alterations OR use of  insulin alone or in combination with metformin with no severe hypoglycemia
  • HbA1c ≥6.5% and ≤8.0% in the previous 3 months
  • Preexisting vascular disease, defined as having any one of the following:

    a) History of major clinical manifestation of coronary artery disease (i.e. myocardial infarction, surgical or percutaneous [balloon and/or stent] coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥50% in a major epicardial artery or branch vessel)

    b) Ischemic cerebrovascular disease including:
     -history of ischemic stroke
     - history of carotid arterial disease as documented by ≥50% stenosis documented by carotid ultrasound, MRI or angiography, with or without symptoms of neurologic deficit

    c) Atherosclerotic peripheral arterial disease, as documented by objective evidence such as amputation due to vascular disease, current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index or toe brachial pressure index less than 0.9 or history of surgical or percutaneous revascularization procedure.
Patient Reimbursement Patients will be reimbursed reasonable travel expenses.
Contact Information Stella Kink
Phone: 416-586-4800 ext. 4447
skink@mtsinai.on.ca

 

Name of Trial LEADER: Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results 
Location Mount Sinai Hospital, Toronto, Ontario
Primary Investigator Dr. Ravi Retnakaran
Supporting Centre Novo Nordisk
Start and End Dates of Trial Start: September 1, 2010
Estimated recruitment end: December 2011
Trial End: 2015 (will vary by randomization date)
Objective of Trial To assess the effect of treatment with liraglutide compared to placebo for at least 3.5 yrs and up to 5 years on the incidence of cardiovascular events, as defined by the primary and secondary endpoints, in adults with type 2 diabetes that are at high risk of cardiovascular events.
Description of Trial A long-term, multi-centre, international, randomized double-blind placebo-controlled trial of comparison of liraglutide or placebo in addition to the care of subject that will otherwise be decided by the subject’s physician(s).  Additional glucose-lowering medications may be added to the diabetes regimen to achieve target glycaemic control. Subjects with type 2 diabetes, anti-diabetic drug naïve or treated with one or more oral anti-diabetic drugs (OAD) or human NPH insulin or long-acting insulin analogue (alone or in combination with OAD(s) will, after an open-label run-in period of two weeks with placebo, be randomized in a 1:1 manner to receive a once daily dose of maximum 1.8mg of liraglutide or equivalent placebo as an add-on to their standard of care (SOC) treatment. Overall trial duration is planned as 18 months of recruitment period followed by 42 months form last subject randomized. Number of primary endpoint events reported in the trial will be monitored throughout the trial, including the recruitment period.  The trial will be completed according to plan when a minimum of 42 months after last subject randomized and number of primary endpoints reported during the trial is equal to or greater than that assumed in the power calculation.
Patient Recruitment Criteria

Key Inclusion Criteria:

  • Men or women with type 2 diabetes
  • Age ≥50yrs at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age ≥60yrs at screening and other specified risk factors of vascular disease
  • HbA1c ≥7.0% at screening 
Patient Reimbursement Patients will be reimbursed for reasonable travel expenses.
Contact Information Stella Kink
Phone: 416-586-4800 ext. 4447
skink@mtsinai.on.ca

 

Name of Trial BI 1245.25  Phase  III, multicentre, international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 ( 10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes patients with increased cardiovascular risk.  BI 10773 is an orally available inhibitor of the sodium-glucose co-transporter 2 (SGLT-2), that promotes enhanced glucose excretion in the urine, thereby lowering blood glucose concentrations in patients with type 2 diabetes mellitus
Location Mount Sinai Hospital, Toronto, Ontario
Primary Investigator Dr. Bernard Zinman
Supporting Centre Boehringer Ingelheim
Start and End Dates of Trial Start: September 2010
End:  Until required number of events has been reached after one year.
Objective of Trial To demonstrate non inferiority of two doses of BI 10773 (10 mg and 25 mg daily) compared to placebo with respect to first occurrence of any of the adjudicated components of the primary composite Major Adverse Cardiovascular Event endpoint (cardiovascular death, non fatal strike, nonfatal myocardial infarction) in patients with type 2 diabetes and increased cardiovascular risk.
Description of Trial In total, 4,000 patients with type 2 diabetes mellitus who meet the entry criteria are planned for inclusion in this event driven trial until the necessary number of events to demonstrate non inferiority (the anticipated trial duration is 206 weeks).  The randomised treatment will be double-blind within the dose groups of BI 10733 and placebo (i.e. two thirds of the patients will receive one active treatment and one third placebo matching the alternative active treatment).

Once the patient is randomized, background therapy should remain unchanged for 12 weeks.  During this period, rescue medication can be added if needed according to protocol.  After the 12 week period adjustments in antidiabetic therapy will be allowed at the Investigator’s discretion to control glucose values and HbA1c according to clinical judgment.
Patient Recruitment Criteria

Key Inclusion Criteria:

  • M or F ≥ 18 years with T2DM on diet and exercise regimen who are drug-naïve or pre treated with any background therapy.
  • Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization. If insulin is part of the background therapy, the insulin dose should not be changed within the 12 weeks prior to randomization by more than 5% daily from the baseline value at randomization.
  • HbA1c ≥7.0% ≤10% at screening for patients on background therapy or AbA1c≥7% or ≤8.0% at screening for drug naïve patients
  • BMI  ≤ 45 kg/m2
  • Must have high cardiovascular risk, defined as at least one of the following:
    - history of myocardial infarction (> 2 months prior)
    - unstable angina (> 2 months prior) with documented multi vessel coronary disease (of at least two major coronary arteries in angiogram) or positive stress test (ST segment depression ≥ 2mm or a positive nuclear perfusion scintigram.
  • Multi vessel Percutaneous Coronary Intervention (PCI) >2 months prior
  • Multi vessel coronary Artery By-pass Grafting (CABG) . 4 years prior or with recurrent angina following surgery
  • History of ischemic or hemorrhagic stroke (.>2 months prior)
  • Peripheral occlusive arterial disease (previous limb bypass surgery or percutaneous transluminal angioplasty; previous limb or foot amputation due to circulatory insufficiency, angiographic or imaging detected (> 50% stenosis or major limb arteries)
Patient Reimbursement Patients will be reimbursed for reasonable travel expenses.
Contact Information Stella Kink
Phone: 416-586-4800 ext. 4447
skink@mtsinai.on.ca

 

Name of Trial A randomized, double-blind, 3-arm parallel-group, 2-year (104- week) multicenter study to evaluate the efficacy, safety and tolerability of JNJ-28431754 100 mg and JNJ-28431754 300 mg compared with glimepiride in the treatment of subjects with type 2 diabetes mellitus not optimally controlled on metformin monotherapy
Location St. Michael’s Hospital Health Centre
61 Queen St. East, Room 6-121
Toronto, Ontario
Primary Investigator Dr. Lawrence A. Leiter
Supporting Centre St. Michael’s Hospital 
Start and End Dates of Trial Start: March 2010
End: March 2012
Objective of Trial The purpose of this study is to compare use of metformin plus cangliflozine 100 mg,  or metformin plus canagliflozine 300 mg, or metformin plus glimepiride on the effect on your diabetes control: change in  A1c, body weight, incidence of low blood sugar,  blood pressure, fasting glucose and overall safety and tolerability.
Description of Trial About 1200 participants in total, on metformin only or metformin and one other anti-diabetes drug, 2-week run in plus 104-week treatment with the study product or glimepiride. 
Patient Recruitment Criteria

Inclusion Criteria:

  • On metformin only or metformin and one other anti-diabetes drug
  • A1c 7-9
  • No insulin use
Patient Reimbursement Travel ( parking, TTC ) expenses, breakfast on fasting visit, meter and strip, and metformin, plus study product provided.
Contact Information Leslie Berndl, MSc, RD
St. Michael’s Hospital Health Centre
61 Queen St. East, Room 6-124
Toronto, ON M5C 2T2
Phone: 416-867-7423   Fax: 416-867-3696

 

Name of Trial Oral Insulin for prevention of diabetes in relatives at risk for type 1 diabetes mellitus
Location The Hospital For Sick Children, Toronto, Ontario
Primary Investigator Dr. Diane Wherrett
Supporting Centre National Institutes of Health
Start and End Dates of Trial Start: November 2006
End: June 2014
Objective of Trial The primary objective is to determine whether intervention with repeated oral administration of recombinant human insulin will prevent or delay the development of clinical Type 1 Diabetes Mellitus (T1DM) in subjects at risk for T1DM.  
Description of Trial The study is a 2-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. Subjects will receive oral insulin 7.5 mg of recombinant human insulin crystals or placebo in capsules.  The primary outcome is the elapsed time from random treatment assignment to the development of diabetes among those enrolled in the primary analysis cohort consisting of subjects with insulin autoimmunity and absence of metabolic abnormalities.
Patient Recruitment Criteria

Inclusion Criteria:

  • Have a relative with T1DM.
  • If the proband is a sibling, parent 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, Grandparent, Cousin), the study participant must be 3-20 years of age.
  • Willing to sign Informed Consent Form.
  • Has normal glucose tolerance on an Oral Glucose Tolerance Tests (OGTT) performed within 7 weeks prior to randomization.
  • mIAA confirmed positive within the previous six months.
  • At least one other antibody present on two separate samples, one of which was drawn within the past six months.

Exclusion Criteria:

  • Has severe active disease, e.g. chronic active hepatitis, severe cardiac, pulmonary, renal, hepatic, immune deficiency and/or disease that is likely to limit life expectancy or lead to therapies such as immunosuppression during the time of the study.
  • Prior participation in a clinical trial for secondary prevention of T1DM.
  • History of treatment with insulin or oral hypoglycemic agent.
  • History of therapy with immunosuppressive drugs or non-physiologic glucocorticoids within the past two years for a period of more than three months.
  • Ongoing use of medications known to influence glucose tolerance, i.e. sulfonylureas, growth hormone, metformin, anticonvulsants, thiazide or potassium depleting diuretics, beta adrenergic blockers, niacin. Subjects on such medications should be changed to a suitable alternative, if available, and will become eligible one month after medication is discontinued.
  • Pregnant or intends to become pregnant while on study or lactating.
  • Deemed unlikely or unable to comply with the protocol.
  • OGTT that reveals abnormal glucose tolerance unless two subsequent consecutive OGTT have normal glucose tolerance.  Abnormal glucose tolerance is defined as:
    *fasting plasma glucose > 110 mg/dL (6.1 mmol/l), AND/OR
    *2 hour plasma glucose >  140 mg/dL (7.8 mmol/l) AND/OR
    *30, 60, or 90 minute plasma glucose > 200 mg/dL (11.1 mmol/l)
  • Subject has HLA DQA1*0102, DQB1*0602 haplotype.
Patient Reimbursement Reimbursement offered for parking or transit costs.
Contact Information Jose Cevallos (Project Manager)
The Hospital for Sick Children
Phone: 416-813-5858 or toll-free 1-866-699-1899
E-mail: jose.cevallos@sickkids.ca

Mithula Sriskandarajah (Research Coordinator)
The Hospital for Sick Children
Phone: 416-813-7654 x 2634 or toll-free 1-866-699-1899
Email: mithula.sriskandarajah@sickkids.ca

 

Name of Trial Emotions and Glycemic Control in Type 1 Diabetes
Location Diabetes Clinic at the Toronto General Hospital and Diabetes Clinic at the McMaster University Medical Centre, Hamilton, Ontario
Primary Investigator Dr. Gary Rodin and Dr. Peter A. Hall
Supporting Centre Canadian Institutes of Health Research
Start and End Dates of Trial Start: June 1, 2008
End: December 1, 2013
Objective of Trial The purpose of this study is to understand more about people’s feelings and opinions about living with diabetes. Specifically, the surveys involved in this study ask questions about your general physical health, about your emotions and feelings toward managing your illness, and about how having Type 1 diabetes has impacted on your life (e.g., physically, emotionally, socially). We are interested in exploring how certain fears and concerns (i.e., fear of low blood sugars, fear of long-term diabetes-related medical complications) influence how people with Type 1 diabetes self-manage their condition, and examining how these concerns may or may not affect their quality of life
Description of Trial This study uses a prospective cohort design. Participants are asked to complete one survey package on three separate occasions (baseline, 1-year follow-up, 5-year follow-up). Surveys can be completed either online (using your home computer) or paper copy. Participants will also be asked to provide consent for researchers to access the following information from their medical health records at either TGH or MUMC: 1) Current A1C (an average measure of blood sugar for the past 120 days), 2) the date you were first diagnosed with Type 1 diabetes, 3) how your diabetes is being treated (e.g., medication type, dose), 4) presence and severity of any diabetes-related complications (e.g., nerve damage, vision problems), and 5) presence of any other medical conditions that you may have. (Note:  This information is already collected by your endocrinologist as part of your standard clinical care. Therefore, no additional medical tests are required for participation in this study). A total of 330 participants (165 from TGH, 165 from MUMC) will be recruited for this study
Patient Recruitment Criteria Adults (18-years-old +), with diagnosis of Type 1 diabetes
Patient Reimbursement $10.00 for the completion of the baseline survey, $5.00 for the completion of each additional follow-up survey
Contact Information Michael Coons, (Study Coordinator)
Tel: (416) 710-7762
E-mail: diabetes@uwaterloo.ca  
Website:  www.arts.uwaterloo.ca/~diabetes


Name of Trial The Natural History of the Development of Type 1 Diabetes Study
Location The Hospital For Sick Children, Toronto, Ontario
Primary Investigator Dr. Diane Wherrett
Supporting Centre National Institutes of Health
Start and End Dates of Trial Start: June 2004
End: June 2014
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 Lesley Eisel (Research Nurse)
The Hospital for Sick Children
Phone: 416-813-7654 x 1798 or toll free 1-866-699-1899
E-mail: lesley.eisel@sickkids.ca

Jose Cevallos (Project Manager)
The Hospital for Sick Children
Phone: 416-813-5858 or toll-free 1-866-699-1899
E-mail: jose.cevallos@sickkids.ca