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Canadian Trials
Alemtuzumab Induction in Islet Transplantation We propose to
combine alemtuzumab induction pre-transplant, with tacrolimus and
mycophenolate mofetil maintenance immunosuppression post-transplant.
Study start: November 2005.
Inclusion Criteria:
* open to Canadians only
* participant must have had Type 1 diabetes mellitus for more than 5
years
* diabetes must be complicated by at least 1 of the following situations
that persist despite intensive insulin management efforts: (1) Reduced
awareness of hypoglycemia, as defined by the absence of adequate
autonomic symptoms at plasma glucose levels < 3.0 mmol/L, indicated by,
2 or more episodes of severe hypoglycemia requiring third party
assistance within 12 months; or (2) Metabolic instability, characterized
by erratic blood glucose levels that interfere with daily activities and
or 2 or more hospital visits for diabetic ketoacidosis over the last 12
months.
* Participants must be capable of understanding the purpose and risks of
the study and must sign a statement of informed consent.
Exclusion Criteria:
* Severe co-existing cardiac disease
* Active alcohol or substance abuse, to include cigarette smoking
* Psychiatric disorder making the subject not a suitable candidate for
transplantation
* History of non-adherence to prescribed regimens
* Active infection including Hepatitis C, Hepatitis B, HIV, TB
* Any history of or current malignancies except squamous or basal skin
cancer
* BMI > 28 kg/m2 at screening visit
* Creatinine clearance < 65 mL/min/1.73 m2
* Blood creatinine > 150 µmol/L (1.7 mg/dL)
* Macroalbuminuria (urinary albumin excretion rate > 300 mg/24h)
* Baseline Hb < 105g/L (<10.5 g/dL) in women, or < 130 g/L (<13 g/dL) in
men
* Baseline screening liver function tests outside of normal range
* Untreated proliferative retinopathy
* Positive pregnancy test, intent for future pregnancy or male subjects’
intent to procreate, failure to follow effective contraceptive measures,
or presently breast feeding
* Previous transplant, or evidence of significant sensitization on PRA
* Insulin requirement >1.0 U/kg/day
* HbA1C >12%
* Uncontrolled hyperlipidemia
* Under treatment for a medical condition requiring chronic use of
steroids
* Use of coumadin or other anticoagulant therapy (except aspirin) or
subject with PT INR > 1.5
* Untreated Celiac disease
* Patients with Graves disease will be excluded unless previously
adequately treated with radioiodine ablative therapy
Please refer to this study by ClinicalTrials.gov identifier NCT00175253
A.M. James Shapiro, MD, PhD 780-407-7330
Canada, Alberta
University of Alberta - Clinical Islet Transplant Program, Edmonton,
Alberta, T6G2C8, Canada; Recruiting
Tara L McCready, PhD, MBA 780-407-6952
A.M. James Shapiro, MD, PhD, Principal Investigator
Clinical Islet Transplantation Using the Edmonton Protocol
Not yet open for patient recruitment
The purpose of this study is to perform a series
of islet transplants using the Edmonton protocol. Patients with Type I
Diabetes and glycemic lability, severe hypoglycemia or hypoglycemic
unawareness will undergo transplantation of purified pancreatic islets
from cadaveric donors into the portal vein, followed by steroid-free
immunosuppression as per the Edmonton protocol (IL-2 antibody induction,
sirolimus, low dose tacrolimus-based immunosuppression). The goals of
the transplant are to improve glycemic control, stabilize blood sugars
and achieve insulin independence.
Inclusion Criteria:
* age 18-65 years
* type 1 diabetes for at least 5 years
* at least 1 of the following: a) frequent, severe hypoglycaemia b)
hypoglycemic unawareness* c) glycemic lability despite an optimal
insulin regimen*, and failure of intensive insulin therapy as judged by
independent endocrinologist
Canada, Ontario
London Health Sciences Centre University Campus, London, Ontario, N6A
4L6, Canada
Charlotte G McDonald, MD, Sub-Investigator
David White, MD, Sub-Investigator
Vivian McAllister, MD, Sub-Investigator
Study chairs or principal investigators
William Wall, MD, Principal Investigator, University of Western Ontario,
Canada
Drug Cost Study
Volunteers for Group Discussions
in Vancouver A Simon Fraser University researcher is interested
in finding persons with diabetes and cardiovascular disease to
participate in group discussions about these conditions, and the use of
prescription drugs. The discussions will be held in Vancouver over the
coming months and will contribute to a growing knowledge-base on the
policy issues surrounding the treatment and management of
these conditions. Volunteers are required to attend one group
discussion, lasting roughly an hour, and will be paid $25 for their
time, plus have their travel costs covered. To be eligible, a person
must have household income between $30k and $50k. If you live in the
lower mainland area, and are interested in participating, please contact
Chris at: 604-417-6743, or email
cwadams@sfu.ca
Effects of Rituximab on the Progression of Type 1 Diabetes in New Onset
Subjects This study will investigate the use of rituximab to see
if it can help lower the number of immune B cells thereby preventing the
destruction of any remaining insulin producing beta cells that remain at
diagnosis. The goal of this study is to find out if rituximab can
preserve residual insulin secretion and prevent further beta cell
destruction in type 1 diabetes.
Inclusion Criteria:
* Between the ages of 12 and 45 years
* Within 3 months of diagnosis of type 1 diabetes
* Have presence of at least one diabetes-related autoantibody
* Must have stimulated C-peptide levels of at least 0.2 pmol/ml measured
during a mixed meal tolerance test (MMTT) within one month of
randomization
* If female with reproductive potential, willing to avoid pregnancy and
undergo pregnancy testing while participating in the study
* Have not received an immunization for at least one month
* Must be willing to comply with intensive diabetes management
* Must weigh at least 25 kg at study entry
Exclusion Criteria:
* Are immunodeficient or have clinically significant chronic lymphopenia
* Have an active infection or positive purified protein derivative (PPD)
test result
* Currently pregnant or lactating; or anticipate becoming pregnant.
* Require chronic use of steroids
* Have current or past HIV, hepatitis B, or hepatitis C infection
* Have any complicating medical issues that interfere with study conduct
or cause increased risk
* Have a history of malignancies
* Currently using non-insulin pharmaceuticals that effect glycemic
control
* Currently participating in another type 1 diabetes treatment study
The Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada; Not yet
recruiting
Natasha Razack, MPH,CCRP 866-699-1899 natasha.razack@sickkids.ca
Diane Wherrett, MD, Principal Investigator
See website for US contact information.
Feasibility Study of 2000 IU Per Day of
Vitamin D for the Primary Prevention of Type 1 Diabetes
Currently recruiting patients
Recent studies of potential risk factors in
children with diabetes, along with studies revealing the immunologic
properties of vitamin D, and experiments in animals suggest higher doses
of vitamin D may prevent type 1 diabetes.
Inclusion Criteria:
* HLA genotypes that increase risk of type 1 diabetes: heterozygous for
DRB1*03, DQA1*0501, DQB1*0201 / DRB1*04, DQA1*03011, DQB1*0302 (DRB1*04
≠ *0403 or related alleles), or homozygous for DRB1*03, DQA1*0501,
DQB1*0201, or homozygous for DRB1*04, DQA1*03011, DQB1*0302 (DRB1*04 ≠
*0403 or related alleles).
Please refer to this study by
ClinicalTrials.gov identifier NCT00141986
Dan Catte, RD 977-5645 dcatte@mich.ca
Lori D Berard, RN 204-789-3228
lberard@hsc.mb.ca
Canada, Manitoba
Manitoba Institute of Child Health, Winnipeg, Manitoba, Canada;
Recruiting
Daniel Catte dcatte@mich.ca
Lori Berard lberard@hsc.mb.ca
Shayne P Taback, MD FRCPC, Principal Investigator
Hope A Weiler, PhD, Sub-Investigator
Cheryl Rockman-Greenberg, MD FRCPC, Sub-Investigator
Heather J Dean, MD FRCPC, Sub-Investigator
Tom Blydt-Hansen, MD FRCPC, Sub-Investigator
Study chairs or principal investigators
Shayne P Taback, MD FRCPC, Principal Investigator, University of
Manitoba
Natural History Study of the Development of Type 1 Diabetes
Current recruiting patients.
TrialNet is an international network dedicated to the study, prevention,
and early treatment of type 1 diabetes. TrialNet sites are located
throughout the United States, Canada, Finland, United Kingdom, Italy,
Germany, Australia, and New Zealand. TrialNet is dedicated to testing
new approaches to the prevention of and early intervention for type 1
diabetes.
The goal of the TrialNet Natural History Study of the Development of
Type 1 Diabetes is to enhance our understanding of the demographic,
immunologic, and metabolic characteristics of individuals at risk for
developing type 1 diabetes.
The Natural History Study will screen relatives of people with type 1
diabetes to identify those at risk for developing the disease. Relatives
of people with type 1 diabetes have about a 3 to 4 percent chance of
being positive for the antibodies associated with diabetes. TrialNet
will identify adults and children at risk for developing diabetes by
testing for the presence of these antibodies in the blood. A positive
antibody test is an early indication that damage to insulin-secreting
cells may have begun. If this test is positive, additional testing will
be offered to determine the likelihood that a person may develop
diabetes. Individuals with antibodies will be offered the opportunity
for further testing to determine their risk of developing diabetes over
the next 5 years and to receive close monitoring for the development of
diabetes.
Inclusion Criteria:
* Individuals 1 to 45 years old who have an immediate family member with
type 1 diabetes (such as a child, parent, or sibling)
* Individuals 1-20 years old who have an extended family member with
type 1 diabetes (such as a cousin, niece, nephew, aunt, uncle,
grandparent, or half-sibling)
In Canada: Ontario
The Hospital for Sick Children, Toronto, Ontario, M5G-1x8, Canada;
Recruiting
Natasha Razack, MPH (866) 699-1899 natasha.razack@sickkids.ca
Diane Wherrett, MD, Principal Investigator
New Onset of Type 1 Diabetes Mycophenolate Mofetil-Daclizumab
Clinical Trial Currently recruiting patients
The goal of this study is to find out if two medicines are
able to stop the ongoing destruction of beta cells which are still
functioning at the time type 1 diabetes is diagnosed
Inclusion Criteria:
Potential participants must meet the following inclusion criteria:
* Be within 3-months of diagnosis of type 1 diabetes based on American
Diabetes Association (ADA) criteria
* Be between the ages of 8 and 45 years old
* Must have stimulated C-peptide levels > 0.2 pmol/ml (measured during
an MMTT administered no more than one month prior to the date of
randomization)
* Must have either detectable anti-GAD, anti-ICA512/IA-2, insulin
autoantibodies (unless received insulin therapy for 7 days or more), or
islet cell autoantibodies.
[The reason for inclusion of these enrollment criteria is to avoid
inclusion of patients with “Type 1B diabetes mellitus”, which may not
involve the immunologic criteria measured by the assays that will be
utilized.]
* If participant has reproductive potential, he or she must be agreeable
to an effective form of birth control (unless abstinence is the chosen
method).
* If participant is female with reproductive potential, she must be
willing to undergo pregnancy testing and to report possible or confirmed
pregnancies promptly during the course of the MMF/DZB study.
* Must be willing to comply with intensive diabetes management. The goal
of management will be an HbA1c of 7.0% for all participants, regardless
of age. Participants will be expected to take a sufficient number of
daily insulin shots to meet this goal. Alternatively, participants can
use insulin pump therapy. Participants will also be expected to test
their blood sugar at least 3-4 times per day. There will be a Certified
Diabetes Educator working with study participants to achieve these
goals.
Canada, Ontario
Hospital for Sick Children, Toronto, Ontario, M5G 1X8, Canada; Not yet
recruiting
Lesley Eisel, RN 866-699-1899
lesley.eisel@sickkids.ca
Protégé: Research to
Protect Beta Cells
Ontario
Robert Luton, MD - Principal Investigator
Shannen Douglass - Study Coordinator
Oxford IAM Clinic
London, ON
(519) 679-8541
We are finalizing our study site list in Canada.
Can't find a site near you? Contact us for help
To be in the Protégé study, you must:
Be 8 to 35 years of age
Have had your first visit to a doctor for symptoms of type 1 diabetes
and received that diagnosis within 12 weeks of starting treatment on
this study
Weigh at least 36 kg (79 lbs)
Not be using any other experimental treatment during the time you are in
the study
Not have received treatment with a monoclonal antibody within 1 year
before joining the study
Not currently be using or planning to use inhaled insulin
Not have received a vaccination with a live virus within 12 weeks before
joining the study
The Protégé study will enroll up to 530 people at approximately 85
medical facilities and 10 countries. Each person's participation will
last two years.
What will I need to do if I am in the Protégé study?
MacroGenics, the manufacturer of teplizumab, is trying to determine the
safest and most effective dose of teplizumab that may protect beta cells
in people with newly diagnosed type 1 diabetes.
You (or your child) will be asked to:
Confirm that you have had your first visit to a doctor for symptoms of
type 1 diabetes and received that diagnosis within 12 weeks of starting
treatment on this study
Give consent for the study
Have urine and blood tests to see if you qualify for this study
Receive daily IV infusions of the study drug for 14 consecutive days.
This will happen twice: at the very beginning of the study and then
again 6 months later.
Attend 14 additional study visits during the two-year study commitment
Why should I (or my child) join the Protégé study?
People with type 1 diabetes are prone to a number of complications from
the disease. These include heart disease, kidney disease, high blood
pressure, and blindness. You or your child may or may not directly
benefit from this study. What we learn from this study will be added to
the research knowledge base and may help others at risk for type 1
diabetes. You will need to weigh the possible risks of the study
medication against the possible benefits of participating in the study.
Those who join the study will receive, at no cost:
Close monitoring of their disease
Direct access to doctors or nurses to answer questions and concerns
Physical exams
Blood work
Study medication
Rights and responsibilities of Protégé study participation
Those who join a clinical study have certain rights and
responsibilities. A doctor or nurse who is running the study will
explain to study volunteers their rights and responsibilities.
For example, as a volunteer you have the right to:
Talk to the study doctor about other kinds of treatment, which may
include having usual diabetes treatment under the guidance of your own
doctor without any experimental study drug or joining another clinical
study
Be informed about all risks and benefits of the study
Have access to study staff to answer all questions
Have new information that pertains to your safety or that may affect
your willingness to continue participation in this study
Have your health carefully and frequently monitored
Be able to leave the study if you no longer wish to participate
Study volunteers will also be asked to make a commitment to the study.
Responsibilities include:
Following the study requirements, which include keeping study
appointments, receiving study medication, and completing a diary card
Answering study questions honestly
The Protégé study is carefully designed to accurately collect
information and evaluate a potential new treatment for type 1 diabetes.
After the Protégé study findings are analyzed, the researchers will
share the results with study volunteers.
Renal and Peripheral Hemodynamic Function in Patients With Type 1
Diabetes Mellitus Not yet recruiting
patients.
The purpose of this study is to determine the
effects of ruboxistaurin mesylate, an inhibitor of PKC in patients with
type 1 diabetes with early diabetic kidney disease to decrease the
damage that diabetes causes to the kidneys and blood vessels.
For additional information regarding
investigative sites for this trial, contact 1-877-CTLILLY
(1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Eastern Time
(UTC/GMT - 5 hours, EST), or speak with your personal physcian.,
Toronto, Ontario, Canada
Eli Lilly
TRX4 (anti-CD3
monoclonal antibody) Therapeutic Evaluation of Different Multiple Dose
Regimens in Type 1 Diabetes (TTEDD)
Not
Yet Open For Patient Recruitment
TolerRx is
developing TRX4 (Fc-altered anti-CD3 monoclonal antibody) for the
treatment of new-onset type 1 diabetes. The clinical development
program is intended to demonstrate that treatment with TRX4 can; (1)
preserve beta-cell function and (2) improve clinical outcomes in
patients by preventing serious hypoglycemic events, improving glycemic
control and reducing the risk of long-term vascular complications. The
purpose of this Phase II study is to determine an optimal multi-dose
regimen for TRX4.
Inclusion
Criteria:
Ø
18–60 years old, willing to provide informed consent
Ø
Established or new onset autoimmune Type 1 diabetes mellitus diagnosis
Ø
Type 1 autoantibody positivity, either islet cell autoantibody (ICA),
glutamic acid decarboxylase (anti-GAD), or anti-1A-2A
For more information please
contact Jessica Snyder at (617) 452-1356 or
jsnyder@tolerrx.com. Please see our company website at
www.tolerrx.com
Research coming out of Sick Kids' Hospital
(status from researchers)
Due to an overwhelming response to our diabetes
research study published in CELL, we are struggling to send a reply to
all the people that have sent e-mails and calls seeking to participate
in the up-coming clinical studies in humans.
These studies have been in planning stages for some time and will start
early in 2007 and take 1 to 2, at the outside 3 years. To greatly
accelerate this process, we will not be recruiting new families, but
invite subjects already participating in the long-term TRIGR diabetes
prevention trial. We have not begun this process, but expect to start in
January 2007.
These studies do not include patient treatments, but involve
non-invasive measurements of sensory nerve functions. Once the results
are available and analyzed, we will be able to consider new therapeutic
strategies now identified in animal experiments. Your e-mails and
messages will be kept on file and if your help in the Clinical Trial
will become possible, we will be able to contact you.
We are confident that this is the most expeditious strategy to hopefully
translate our new insights from animal experiments to the human disease.
For the joint Diabetes intervention Team at the Toronto Hospital for
Sick Children,
H.-Michael Dosch, MD, PhD
Professor of Pediatrics
Professor of Immunology
University of Toronto
The Hospital For Sick Children
Type
1 Diabetes Aerobic and Resistance Exercise (T1-DARE)
Currently recruiting patients The
primary objective of this study is to determine the effects of
resistance exercise training, and of aerobic exercise training, on
glycemic control (A1c) in previously inactive individuals with type 1
diabetes, with background therapy meeting modern standards, including
multiple daily insulin injections or insulin pump, carbohydrate
counting, frequent glucose monitoring, and utilization of glucose
monitoring to adjust CHO and insulin for exercise.
Secondary aims: In type 1 diabetic individuals receiving therapy meeting
the criteria above, to determine the effects of resistance exercise
training and aerobic exercise training on frequency of hypoglycemia,
body composition, lipids, C-reactive protein and quality of life.
Inclusion Criteria:
* Type 1 diabetes mellitus as defined by the 2003 CDA guidelines (16)
requiring insulin therapy starting within one year of diagnosis and
continuously thereafter
* Male or female, age 16-45 years, A1c 0.066-0.090
* Physically inactive (see exclusion criteria below)
* Willingness and ability to work closely with the study physicians,
nurse and dietitian and follow intensive diabetes therapy including
carbohydrate counting, glucose monitoring ≥4 times per day, and
intensive insulin therapy--either by multiple daily injections
(MDI--insulin aspart or lispro before meals and NPH or insulin glargine
1-2X/day) or continuous subcutaneous insulin infusion (CSII) by pump
therapy using insulin aspart or lispro for the duration of involvement
in the study. CSII will only be an option for those already on CSII
prior to entry in the study.
Canada, Ontario
Ottawa Health Research Institute, Ottawa, Ontario, K1Y 4E9, Canada;
Recruiting
Penny A Phillips, B.Sc. MA 613-738-8400 Ext. 81959
pphillips@ohri.ca
Eli Lilly has three studies ongoing. The
first will be recruiting in Manitoba, Ontario and Quebec. It is a
Phase III, open-label randomized study to evaluate safety and efficacy
of Alkermes®, inhaled insulin system, as compared to injected insulin in
non-smoking adults with Type 1 and Type 2 Diabetes who also have asthma
or COPD. This is a 12 month treatment with a 2 month follow up. The
trial runs from August 2005 until December 2007.
Lilly is running another Phase III open label study in Manitoba,
Ontario, and Quebec to evaluate the
safety and efficacy of inhaled insulin as compared to injected
pre-meal insulin in non-smoking adults with Type 1 Diabetes over a 24
month period with a 2 month follow up. This trial runs from July 2005
until May 2008.
Lilly’s final study evaluates the
durability of starter insulin regimens in patients with Type 2
Diabetes. It will look at insulin lispro mixtures and glargine in
combination with patients’ oral medicines for their ability to control
blood glucose levels in patients with Type 2 Diabetes and compare
insulin lispro low mixture with regard to the length of time that the
overall blood glucose level can be controlled. This is a Phase IV trial
that was started in December 2005 and will end in June 2010. Patients
must be between 30-79 years old. Trials are being held in British
Columbia, Alberta, Manitoba, New Brunswick, Nova Scotia, Ontario, and
Quebec.
Pfizer and Sanofi-Aventis have two studies ongoing in Canada. The first
is a one year clinical
trial assessing the usefulness and safety of inhaled insulin in
diabetics with asthma. It studies patients with Type 1 and Type 2
diabetes on insulin injections who also have mild to moderate asthma.
Trials are ongoing in Alberta, British Columbia, Manitoba, Nova Scotia,
Ontario and Quebec.
The second clinical trial by these two companies is also a one year
clinical trial that is assessing the
usefulness and safety of inhaled insulin in diabetics with COPD.
This randomized, open label trial began in November 2002. Subjects are
between 30-75 years old, have Type 1 or Type 2 diabetes, use insulin
injections and live in Alberta, British Columbia, Manitoba, Ontario, or
Quebec.
Trial to Reduce Insulin Dependant Diabetes
Mellitus in the Genetically at Risk (TRIGR) The goal of the
TRIGR study is to determine whether it is possible to reduce the risk of
diabetes in children of parents who have a type 1 diabetes mellitus.
Studies in many countries suggest that the early introduction of baby
formulas made from cows milk may be related to the early development of
diabetes.
Participants Must:
* be a newborn child who has a mother, father, brother or sister who has
insulin-dependent type 1 diabetes, and therefore has a higher risk of
developing diabetes OR
* be a pregnant woman or father who has type 1 diabetes. OR
* be a pregnant woman who has a child with type 1 diabetes
Contact: Mary-Jean Martin, RN
TRIGR Toronto , Mount Sinai Hospital
Phone: 1-416-586-4800 extension 2977
Web Address: www.trigr.org
Research Study
The Type 1 Diabetes Genetics Consortium Study
Overview
The ultimate goal of the study is to provide the genetic and clinical
resources necessary to achieve a significant sample size for type 1
diabetes gene identification. We hope to ascertain, study and establish
a renewable source of DNA on 1100 “affected sib-pair” (ASP) families
with at least two type 1 diabetic siblings, their parents, and up to two
non-diabetic siblings for studies to map genes that may be associated
with type 1 diabetes.
Inclusion Criteria
Affected Sibling Pair (ASP) Families are welcomed to participate in this
study.
An ASP family is made up of:
* 2 affected siblings who have a diagnosis of type 1 diabetes, with age
at onset prior to 30 years.
* Both biological parents available for study and, when present, an
unaffected (non-diabetic) sibling.
* All family members must be available for collection of blood for
phenotyping and genetic analysis.
* No reimbursement will be offered for participation, but participants
will be reimbursed for transportation costs.
Contact Information
Dr. Diane Wherrett (Principal Investigator)
Susan McIntyre (Research Nurse) at the Hospital for Sick Children
phone: 416-813-7654 (x 2308) or
toll-free: 1-866-699-1899 or
e-mail:susan.mcintyre@sickkids.ca
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