Diabetes Alliance Projects

Alliance for Healthy Hearts & Minds (CVCD) (2014-2015)
The CVCD Alliance aimed to determine the causes of heart disease, stroke, cancer, and other chronic diseases and their risk factors, and also factors influencing overall health and disease among Canadians. Approximately 10,000 participants from across Canada will be invited to participate in this program to: 1) understand the role of socio-environmental and contextual factors on CV risk factors, subclinical disease, and clinical CV events at the individual and population levels. This will include investigating the impact of contextual factors on geographic variation in CVD, and their relative impact compared to individual level factors; 2) characterize the unique patterns of contextual factors (as defined above) as well as acculturation, cultural continuity, and migration experience as related to individual CV risk factors, health service utilization, and clinical outcomes among high risk ethnic groups including South Asians, Chinese, African origin, and reserve-based Aboriginal people from across Canada; and 3) identify early subclinical dysfunction in the brain, vessels and the heart using magnetic resonance imaging, and to investigate the associations with contextual and individual determinants of this dysfunction, as well as to assess the predictive value of novel markers of subclinical dysfunction on the development of clinical CV events.

The First Nations Diabetes Surveillance System (FNDSS) (Pilot began in 2012)
The First Nations Diabetes Sentinel Surveillance System (FNDSS) was developed as a system to address the health gap around limited surveillance and evaluation of diabetes in Indigenous communities in Canada. FNDSS is a web-based system that encompasses community diabetes registries and surveillance of diabetes clinical measures. The system allows users to view their historic clinical indicators and prevalence, enter data, and review and track progress and plan quality improvement initiatives. Patient-level and community-level reports and graphs display health performance as compared to the Canadian Diabetes Association Clinical Practice Guidelines recommendations. Honouring the Ownership, Control, Access and Possession principles and the CIHR Guidelines for Health Research Involving Aboriginal Peoples, communities were involved in all aspects of the process, controlled and owned their data, and had access to their data at all times.

Healthy Moms, Healthy Babies (HMHB) – Gestational Diabetes Mellitus (2012-2014)
First Nations women are at an increased risk of developing both type 2 diabetes and gestational diabetes (diabetes during pregnancy), with rates reported to range from 8-18% and on the rise (higher than the general population). Healthy Moms, Healthy Babies was a program developed to help First Nations women manage the effects of gestational diabetes or type 2 diabetes during pregnancy including a Lifestyle Program with regular physical activity and diabetes education sessions. This study assessed the impact of the Community Lifestyle Program on blood sugar levels and weight gain during pregnancy. Also, a comparison of blood sugar levels, delivery experience and baby’s health was done between women who wore a continuous glucose monitor and women who used a standard finger-prick glucose meter.

The Canadian First Nations Diabetes Clinical Management Epidemiologic Study (CIRCLE) (2007-2010)
CIRCLE was a 3-year national research study that partnered with 19 First Nations communities across Canada to document the current state of clinical management of type 2 diabetes and rates of diabetes-related complications and comorbidities in First Nation communities. The CIRCLE study demonstrated that major care gaps exist in the management and treatment of patients with diabetes in First Nations communities. Study results have been presented to First Nation communities and their leaders, and Health Canada policy makers. Four manuscripts have been published; four additional manuscripts are currently in process.

Sandy Lake Health and Diabetes Project (1991-2013)
A multifaceted diabetes prevention program implemented over the past 20 years in the remote fly-in First Nation community of Sandy Lake in northern Ontario. The intervention involved: a school-based diabetes curriculum for children in grades 3 and 4; community activities aimed at increasing awareness and prevention of diabetes including a radio show, walking clubs, grocery store activities, and home visits; and research activities and programs aimed at increasing the understanding of diabetes in the community. The program was developed and monitored through a collaborative partnership between the community and academic researchers. Goals of the Sandy Lake Health and Diabetes Project were to determine the prevalence of diabetes in Sandy Lake, to describe biological and lifestyle factors associated with diabetes, to develop culturally appropriate intervention strategies based on ethnographic data and to provide a model intervention strategy that can be replicated in other First Nations communities. The Sandy Lake Health and Diabetes Project continues to exist in Sandy Lake with the community taking complete ownership of the program and its activities.

REIMAGINE 2 (2024-2026)
A 1.5 year study to see how well CagriSema (the study drug) compared to semaglutide, cagrilintide and placebo lowers blood sugar and body weight in people with type 2 diabetes who are being treated with metformin only or metformin with an SGLT2 inhibitor. This study will mainly look at changes in blood sugar levels and body weight. The observed changes in people who take CagriSema will be compared to changes in people who take semaglutide, cagrilintide or “placebo” medicine. Approximately 2,700 men and women across the world will take part in this study.

REIMAGINE 4 (2024-2026)
A 1.5 year study to see how much the study drug, CagriSema (Cagrilintide + Semaglutide), lowers blood sugar and body weight compared to Tirzepatide (which is available on the market) in people with type 2 diabetes treated with metformin with or without an SGLT2 inhibitor.

SYNCHRONIZE-CVOT (2024-2026)
A 2.5 year study to test the effect of the study drug on cardiovascular safety in people who are overweight or obese. The purpose of this trial is to find out whether the study drug helps people living with overweight or obesity to lose weight without increasing risk to the heart and blood vessels. This will be looked at in patients who have risk factors for cardiovascular disease, or who have established cardiovascular or chronic kidney disease. Approximately 110 people will participate in this trial in Canada and approximately 4935 people worldwide.

COMBINE 2
A 52-week study comparing the efficacy and safety of once weekly IcoSema (weekly insulin Icodec combined with weekly semaglutide) and once weekly semaglutide, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with a GLP-1 receptor agonist. The main purpose of the study is to see how well the investigational medicine IcoSema controls blood sugar levels in people with type 2 diabetes. This will be assessed by examining the change in A1c (3 month blood sugar average) throughout the study. Approximately 680 men and women across the world will take part in this study. The information collected during the study may also help us better understand type 2 diabetes or related diseases, how the study medicine works in the body, and how to improve the treatment of people with type 2 diabetes or related diseases.

ARISE study (2019-2025)
The purpose of the ARISE study is to learn about the effects of the study drug in helping to prevent cardiac disease in people with type 2 diabetes. https://clinicaltrials.gov/ct2/show/NCT04083339?term=ARISE&cond=Diabetes&cntry=CA&city=London&draw=2&rank=1

ONWARDS 3 (2021-2022)
This is a 26 week multi-centre, double-blind trial comparing the effect and safety of once weekly insulin icoden and once daily insulin degludec, both in combination with non-insulin anti-diabetic drugs, in naïve subjects with type 2 diabetes. The purpose of the study is to find out how well insulin icodec (an investigational insulin taken once-weekly) controls blood sugar compared to insulin degludec (a once daily insulin already on the market). https://clinicaltrials.gov/ct2/show/NCT04795531?term=ONWARDS+3&draw=2&rank=1

ONWARDS 5 (2022)
This is a 52 week multi-centre trial to investigate the effectiveness and safety of once weekly insulin icodec (an investigational insulin taken once weekly) used with DoseGuide in comparison to once daily basal insulin analogues, both in combination with any non-insulin antidiabetic medication in insulin-naïve subjects with type 2 diabetes mellitus in a clinical practice setting. The purpose of the study is to find out how well insulin icodec used with a DoseGuide App controls blood sugar compared to already marketed daily insulins. https://clinicaltrials.gov/ct2/show/NCT04760626?term=ONWARDS+5&draw=2&rank=1

RESET-IT (2014-2020)
The central problem in type 2 diabetes (T2DM) is an inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. This "beta-cell dysfunction" worsens over time. No current diabetes medications are known to stop this worsening beta-cell dysfunction; therefore, over time patients need permanent insulin therapy. Recent work suggests that early in the course of T2DM, short-term treatment with intensive insulin therapy (IIT) can temporarily improve beta-cell function. RESET-IT aimed to test a new approach. Participants with recently-diagnosed T2DM were treated with a short course of IIT for 3 weeks and then received either (i) intermittent IIT for 2 week every 3 months or (ii) continuous treatment with metformin (the standard first-line medication for the treatment of diabetes). https://clinicaltrials.gov/ct2/show/NCT02192424?term=RESET-IT&draw=2&rank=1

REMIT-IGlarLixi (2017-2020)
This was a multicentre, open-label, randomized controlled trial for patients with recently-diagnosed T2DM. Participants were randomized to 2 treatment groups: (a) a 12-week course of treatment with IGlarLixi (insulin glargine and lixisenatide), metformin and lifestyle therapy, and (b) standard diabetes therapy, and followed for a total of 68 weeks. In all participants with HbA1C<7.3% at the 12 week visit, glucose-lowering medications were discontinued and participants were encouraged to continue with lifestyle modifications and regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experienced hyperglycemia relapse after stopping drugs received standard glycemic management as informed by the current Canadian Diabetes Association clinical practice guidelines. https://clinicaltrials.gov/ct2/show/NCT03130426?term=REMIT-IGlarLixi&draw=2&rank=1

Lixilan One CAN (2014-2015)
Compared the Efficacy and Safety of Insulin Glargine (Basal Insulin)/Lixisenatide (GLP-1 Receptor Agonist) Combination (Soliqua™) in Patients With Type 2 Diabetes Mellitus (T2DM) (LixilanOne CAN). To demonstrate that the simple daily titration algorithm is non-inferior to the weekly titration algorithm according to Canadian labeling. https://clinicaltrials.gov/ct2/show/NCT02058160?term=LIXILAN+ONE+CAN&draw=2&rank=1

SURE is a prospective study looking at the effectiveness of once-weekly Ozempic (semaglutide) treatment. Participants may experience a difference in their diabetes management and may discover that Ozempic improves their A1c and other outcomes. https://clinicaltrials.gov/ct2/show/NCT03457012?term=NN9535-4428&draw=2&rank=1

CAN-TREAT (2018-2019) is a retrospective data collection study looking at the effectiveness of Tresiba(insulin degludec) after switching basal insulin in a population with type 1 or type 2 diabetes. https://clinicaltrials.gov/ct2/show/NCT03674866?term=CAN-TREAT&cntry=CA&city=London&draw=2&rank=1

PIONEER 8 (2017-2018)
Type 2 diabetes mellitus (T2DM) is a progressive metabolic disease primarily characterised by abnormal glucose metabolism. The pathogenesis is heterogeneous involving environmental, lifestyle and genetic factors leading to chronic hyperglycaemia caused by peripheral tissue insulin resistance, impaired insulin secretion due to abnormal beta-cell function and abnormal glucose metabolism in the liver. The primary objective of the study is to compare the effect of once-daily dosing of three dose levels of oral semaglutide (3, 7 and 14 mg) versus placebo on glycaemic control in subjects with type 2 diabetes mellitus treated with insulin. The secondary objectives are to compare the effect of once-daily dosing of three dose levels of oral semaglutide (3, 7 and 14 mg) versus placebo on body weight in subjects with type 2 diabetes mellitus treated with insulin; and to compare the safety and tolerability of once-daily dosing of three dose levels of oral semaglutide (3, 7 and 14 mg) versus placebo in subjects with type 2 diabetes mellitus treated with insulin. https://clinicaltrials.gov/ct2/show/NCT03021187?term=PIONEER+8&cntry=CA&city=London&draw=2&rank=1

REMIT DAPA (2015-2018)
The REMIT-Dapa study is a randomized, open-label clinical trial which will evaluate whether an intensive 12-week metabolic intervention using a combination of anti-diabetic medications and lifestyle intervention is more effective in achieving drug-free remission of type-2 diabetes than standard diabetes care. The three anti-diabetic medications which will be used for the 12-week therapy are: Forxiga (dapagliflozin), metformin and insulin glargine. https://clinicaltrials.gov/ct2/show/NCT02561130?term=REMIT+DAPA&cntry=CA&city=London&draw=2&rank=1

DECLARE (Dapagliflozin Effect on CardiovascuLAR Events)(2013-2018)
DECLARE was a 5 year study evaluating whether treatment with dapagliflozin (10 mg once daily) reduces major adverse cardiovascular events in patients with type 2 diabetes (T2DM) and with either known cardiovascular disease or at least two risk factors for cardiovascular disease (e.g., age, hyperlipidemia, hypertension, recent smoking history-primary prevention). The primary objective of the DECLARE Study was to determine whether treatment with dapagliflozin when added to current therapy will result in a reduction in the incidence of cardiovascular death, myocardial infarction (MI), or ischemic stroke. https://clinicaltrials.gov/ct2/show/NCT01730534?term=DECLARE&cntry=CA&city=London&draw=2&rank=1

DUAL IX (2016-2018)
This was a trial to confirm the safety and effectiveness of an investigational drug called insulin degludec/liraglutide (IDegLira), which is a combination of 2 drugs: IDeg and Liraglutide. IDegLira is a blood sugar lowering medication that is being developed for the treatment of type 2 diabetes. The purpose of this trial was to investigate the safety and efficacy of adding IDegLira or insulin glargine (IGlar) to the oral anti-diabetic therapy SGLT2i in subjects with type 2 diabetes who are not able to control their blood sugar levels with their current SGLT2i therapy. It is expected that the blood sugar levels will be improved when adding basal insulin like IDegLira or IGlar to the SGLT2i therapy. This research trial planned to include 416 subjects worldwide. https://clinicaltrials.gov/ct2/show/NCT02773368?term=IDegLira&cntry=CA&city=London&draw=2&rank=2

EASE-3 (2016-2017)
In an extensive Phase III program, empagliflozin (10 mg and 25 mg) was shown to be safe and efficacious in the treatment of patients with T2DM and has received marketing approval in more than 30 countries including the EU and US. Due to its insulin-independent mode of action empagliflozin also has potential for use in the treatment of patients with T1DM. Based on exploratory results from two studies in patients with T1DM (see Section1.2.3.2), this Phase III trial was planned to confirm the efficacy and safety of empagliflozin in patients with T1DM and to further investigate tolerability and PK. The objective of this study was to assess the efficacy, safety, tolerability and PK of once daily oral doses of empagliflozin 2.5 mg, 10 mg and 25 mg compared to placebo in patients with T1DM as adjunctive to insulin therapy. https://clinicaltrials.gov/ct2/show/NCT02580591?term=EASE-3&cntry=CA&city=london&draw=2&rank=1

FIAsp (2013-2015)
The FIAsp Study was a 26-week trial comparing the efficacy and safety of meal time FIAsp with meal time insulin aspart and post meal time FIASP, in combination with insulin detemir in a basal-bolus regimen, followed by a 26-week double-blind extension period for the meal time arms. The objective of the FIAsp project was to develop a faster acting insulin formulation. It was expected that the higher early exposure of FIAsp and faster onset of action would provide further clinical benefits in terms of improved prandial glycaemic control, and increased flexibility of dosing than the currently marketed prandial insulin products. https://clinicaltrials.gov/ct2/show/NCT01831765?term=FIAsp%2C+detemir&cntry=CA&city=London&draw=2&rank=1

LEADER (Liraglutide Effects and Action in Diabetes: Evaluation of Cardiovascular Outcome Results)(2010-2015)
LEADER Study was a 5 year study evaluating the effect of Liraglutide (Victoza) on the incidence of cardiovascular events. People with diabetes are at a high risk for cardiovascular disease and many of these risk factors can be reduced by modern therapies. Liraglutide (Victoza), a GLP-1 analogue, has a favourable effect on these risk factors and hence on cardiovascular events. These factors include hyperglycaemia, insulin resistance, dyslipidemia, hypertension, obesity and increased glucagon. https://clinicaltrials.gov/ct2/show/NCT01179048?term=LEADER&cntry=CA&city=London&draw=2&rank=4

CANOE (Canadian Normoglycemia Outcomes Evaluation)(2004-2010)
CANOE was a double-blind randomized controlled trial was completed in Toronto and London. The study investigated whether low-dose combination therapy would prevent development of type 2 diabetes with three published papers including the major findings published in Lancet. https://clinicaltrials.gov/ct2/show/NCT00116922?term=CANOE&cntry=CA&draw=2&rank=1

REMIT IDegLira (2019-2023)
The purpose of the study is to determine whether in patients with early type 2 diabetes, a short-term intensive metabolic intervention comprising IDegLira, metformin, and lifestyle approaches will be superior to standard diabetes therapy in achieving sustained diabetes remission. https://clinicaltrials.gov/ct2/show/NCT03862716?term=REMIT+Ideglira&draw=2&rank=1

DEFINE (2014-2016)
The overall aim of DEFINE was to guide the comprehensive evaluation of diabetes prevention and management, and to facilitate policy innovations in order to improve diabetes care and reduce the clinical and financial burden of diabetes. To accomplish this, the DEFINE Package included: a Five Step Evaluation Framework, a Determinants of Health Schematic (schematic of the relationships between medical and non-medical determinants of health), a Priority Multi-level Indicator Set to emphasize critical indicators that should be part of most comprehensive evaluations, an All-inclusive Multi-level Indicator Set to facilitate the selection of multi-level indicators related to your specific evaluation question(s) (a complete menu of indicators), and a Table of Associated Measurement Tools.

QIIP (Quality Improvement & Innovation Partnership) (2010-2013)
QIIP, now part of Health Quality Ontario, was instituted to assist with the shift from the traditional reactive model of healthcare delivery to a proactive planned approach through the formation of inter-professional care teams, improvement of community healthcare partnerships, and initiation of quality improvement (QI) programs. One QI initiative, learning collaboratives, focused on diabetes, colorectal screening, and access to care. Investigators from Western and Queen’s performed a comprehensive third-party evaluation of the learning collaborative program using surveys, interviews, chart reviews, and health administrative data.

P4H (Partnerships for Health) (2008-2011)
A comprehensive, mixed-method, evaluation of the Partnerships for Health (PFH) project. The PFH project aimed to enhance diabetes management across the continuum of care by integrating the Chronic Care Model, Model for Improvement and IHI Breakthrough Series approach into educational activities, supportive activities, and reporting activities for primary healthcare teams in Southwestern Ontario. The impact of the project on chronic illness care delivery and diabetes care processes and clinical outcomes was assessed and reported in two publications to date.

AIM@GP (2006-2008)
The objective of the AIM@GP study was to determine the effectiveness of an insulin initiation strategy to increase family physician insulin prescribing used a stratified, parallel group, randomized controlled design in family physician practices across Canada.