Diabetes Alliance Projects

FORGE AHEAD

FORGE AHEAD is a five-year research program (2013-2017) seeking to develop and evaluate community-driven, culturally relevant, primary healthcare models that enhance chronic disease management and appropriate access to available services in First Nations communities across Canada. Developed and implemented by a strong multi-disciplinary and cross-jurisdictional team from 8 provinces, the program uses a participatory research approach that simultaneously ensures culturally appropriate implementation and integrates knowledge translation by involving relevant stakeholders throughout the entire program.

SOAR: Pathway to Wellness

SOAR – Pathway to Wellness is –a three-year research program (2017-2020) seeking to improve the health and health equity of Indigenous peoples by working with communities and organizations as equal partners in a community-driven, community-paced and culturally-relevant program. The aim of the program is to build off the lessons from FORGE AHEAD to strengthen the effectiveness and scalability of a promising Quality Improvement (QI) program that fosters community-initiated innovations to improve diabetes management and prevention in First Nations Communities.

InHypo-DM Project

Some pharmacological therapy used to manage diabetes can increase a patient’s risk of hypoglycemia. Hypoglycemia is the most common diabetes-related adverse event, and so the aim of this study is to develop a survey that will explores Canadians’ clinical and personal perspectives and practices related to hypoglycemia and its impact on the management of diabetes. The survey will be founded on the Theoretical Domains Framework (TDF) developed by Cane et al. (2012), the Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) and a comprehensive knowledge translation (KT) approach and will be administered to people with diabetes, their family members, and care providers.

iNPHORM Study

The iNPHORM study is one of the first prospective, longitudinal investigations in the world to be conducted in the area of hypoglycemia. The study seeks to develop hypoglycemia risk prediction models that can be applied across diverse clinical settings and patient populations. The real-world models are intended to support health-care providers in identifying and predicting which patients with diabetes are at highest risk of experiencing hypoglycemia.

DECLARE (Dapagliflozin Effect on CardiovascuLAR Events)
DECLARE is 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 is 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.

RESET-IT
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 aims to test a new approach. Participants with recently-diagnosed T2DM will be treated with a short course of IIT for 3 weeks and then receive 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).

PROMISE (PROspective Metabolism and ISlet cell Evaluation formerly called epi-CANOE)
PROMISE is a 15 year observational (no study medication) study of approximately 800-1000 individuals age 30 and older (18 and older for Aboriginal subjects) at high risk for glucose intolerance. After the 15 year study period, there will be long term follow up through record linkage to the Canadian Institute of Health Information and the Statistics Canada vital statistics databases, both of which are standard methods for determining whether hospitalizations or deaths have occurred among participants. The overall objective of the PROMISE study is to understand the determinants of obesity, impaired fasting glucose, impaired glucose tolerance, T2DM and associated metabolic abnormalities, including insulin resistance, beta cell dysfunction and microalbuminuria.

REMIT DAPA
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.

REMIT IGLARLIXI
Recent research suggests that it may be possible to reverse type 2 diabetes or put it into remission using intensive lifestyle therapy and short-term combination drug therapy with injectable insulin and oral diabetes medications. This trial will test whether a short treatment with a combined basal insulin glargine and lixisenatide (iGlarLixi), metformin, and lifestyle is able to achieve prolonged diabetes remission. The study will be done in 160 people with type 2 diabetes and will take place at several research centres in Canada. The goal of the REMIT-iGlarLixi study is to determine if treating diabetes with several medications and lifestyle changes early in the course of the disease (i.e. within 5 years of diagnosis) will reverse glucose levels back to normal to a point where diabetes may be described as being in “remission”.

PIONEER 8
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.