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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 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 Brenda Ahenkorah (Project Manager)
The Hospital for Sick Children
Phone: 416-813-5858 or toll-free 1-866-699-1899
E-mail: brenda.ahenkorah@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 Effects of Recombinant Human Glutamic Acid Decarboxylase (rhGAD65) Formulated in Alum (GAD-alum) on the Progression of Type 1 Diabetes in New Onset Subjects
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: July 2009
End: July 2011
Objective of Trial It is hypothesized that multiple injections with 20µg GAD-alum preserves endogenous insulin production in type 1-diabetes patients 3-45 years of age, when diagnosed within 3 months prior to the first injection.
Description of Trial The study is a three-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial.  All groups will receive standard intensive diabetes treatment with insulin and dietary management.  Recombinant human glutamic acid decarboxylase (rhGAD65), formulated in aluminum hydroxide is an antigen-specific immune modulator that has been shown to slow or prevent autoimmune destruction of pancreatic beta cells by inducing immune “tolerance”.  Participants will receive 3 injections consisting of 20µg of GAD-Alum x 3, 20µg of GAD-Alum x 2 plus one injection of placebo-Alum, or placebo-Alum x 3.
Patient Recruitment Criteria

Inclusion Criteria:

  • Be between the ages of 3 and 45 years
  • Type 1-diabetes mellitus diagnosed within the previous 3 months  
  • Must have stimulated C-peptide levels ³ 0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month (37 days) of randomization 
  • Presence of GAD65 antibodies

Exclusion Criteria:

  • Be currently pregnant or lactating or anticipate getting pregnant for 24 months after first injection
  • Ongoing use of medications known to influence glucose tolerance
  • Require use of systemic immunosuppressant(s)
  • Have a history of malignancies 
  • Be currently using non-insulin pharmaceuticals to affect glycemic control
  • Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk including neurological abnormalities.
  • Have a history of epilepsy, significant head trauma or cerebrovascular accident or clinical features of continuous motor unit activity in proximal muscles
  • Inability or unwillingness to comply with the provisions of this protocol
  • Have an active infection or positive PPD test result.
  • Have serologic evidence of current or past HIV, Hep B, or Hep C infection.
Patient Reimbursement Reimbursement offered for parking or transit costs.
Contact Information Brenda Ahenkorah (Project Manager)
The Hospital for Sick Children
Phone: 416-813-5858 or toll-free 1-866-699-1899
E-mail: brenda.ahenkorah@sickkids.ca

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

 

Name of Trial Resistance Exercise in Already-active Diabetic Individuals (READI)
Location Diabetes and Endocrinology Clinic
Toronto General Hospital - University Health Network
Primary Investigator Dr. Bruce A. Perkins
Supporting Centre Canadian Institutes of Health Research
Start and End Dates of Trial Start: 2007
End: 2010
Objective of Trial To determine whether addition of resistance exercise training improves glucose control in people with type 1 diabetes who already habitually perform aerobic exercise.
Description of Trial READI is a 11-months randomized parallel-group controlled trial preceded by a 5-week run-in period for the purpose of optimizing basic diabetes management and assessing compliance. After the run-in participants are randomized in equal numbers to a 22-week program of Resistance Training or Waiting-List Control. The resistance training intervention takes place at community facilities throughout GTA (such as YMCA or York University) and is supervised by certified exercise trainers. Participants randomized to Waiting-List Control during the first 22 weeks have the option of supervised resistance training during the final six months. Both groups receive education about diabetes management during and after exercise. Participants are expected to perform resistance training 3 times per week, without decreasing the amount of aerobic exercise.During the run-in period and at 5 months after randomization participants undergo a oxygen capacity (stress) test and radiological tests for body fat composition. In addition to these times, blood is drawn at 3 and 12 months from the beginning of the study.
Patient Recruitment Criteria

Inclusion Criteria:

  • type 1 diabetes
  • HbA1c between 6.6 and 9.9%
  • performing aerobic exercise in minimum of 90-150 min weekly (depends on intensity and type of activities).

Exclusion Criteria:

  • any resistance training in last 4 month
  • brittle diabetes and/or hypoglycemia unawareness
  • significant confirmed retino-/nephro-/neuropathy
  • currently participation in any other interventional research study
Patient Reimbursement There is no financial reimbursement for participation.  However participants will receive a free gym membership (they can use it anytime) and guidance of a personal trainer for the duration of the study.
Contact Information Andrej Orszag
Tel: (416) 340-4800 ext. 7187
E-mail: toronto.general@gmail.com

 

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 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


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

Brenda Ahenkorah (Project Manager)
The Hospital for Sick Children
Phone: 416-813-5858 or toll-free 1-866-699-1899
E-mail: brenda.ahenkorah@sickkids.ca