Lead Investigator: Jay Park, Core Clinical Sciences
Title of Proposal Research: Assessing the Potential Effect of a New Diabetes Treatment in Canadian Populations
Vivli Data Request: 10832
Funding Source: This work is being conducted by employees of Core Clinical Sciences as part of research and development activities. It is self-funded. No funding is being received from outside organizations.
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Project Background
Type 2 diabetes is a disease that causes the level of sugar (glucose) in the blood to become too high. Over 3 million Canadians have type 2 diabetes, with rates varying significantly between provinces. By understanding how to best treat patients at both national and provincial levels, this research could improve care for millions. It aims to benefit a wide range of patients, from those in the relatively remote regions in the North to those living in densely populated urban spaces in the South, by tailoring treatment recommendations to their specific needs. In practice, this means more personalized and effective diabetes care for Canadians, potentially reducing complications from poorly controlled blood sugar. It will also provide a model for adapting trial results to diverse populations worldwide, improving patient care and treatment precision globally.
The SURPASS-3 clinical trial has shown promising results in treating type 2 diabetes. It compared a new medication, tirzepatide, to insulin degludec, a commonly used synthetic insulin. Tirzepatide has glucose-lowering effects which work by stimulating the secretion of insulin and reducing glucagon levels – both of these naturally occuring hormones help maintain blood sugar at the right level. However, the people in clinical trials don’t always represent the diverse populations we see in the real world, such as in Canada. Our study aims to adapt the SURPASS-3 results to better fit Canadian populations, both nationally and in each province.
Why This Research is Necessary
Canada’s diverse demographics mean that diabetes treatments might work differently here compared to the original trial. We currently lack information on how effective these treatments would be in real-world Canadian settings, particularly considering provincial differences. This research is crucial for developing treatment guidelines that better match the needs of specific Canadian populations, leading to more effective and fair diabetes care across the country.
How We’ll Conduct the Research
We’ll use data from the SURPASS-3 trial and nationally and provincially representative data from the Canadian Community Health Survey (CCHS). Using both datasets will allow us to better understand how well this new treatment will work for Canadian populations. The CCHS has been used for over a decade to better understand the clinical epidemiology (the study of the causes, occurrence, and distribution of health and disease in a defined population) of diabetes in Canada. Using advanced statistical methods, we’ll account for differences in factors like age, sex and race and ethnicity that might affect how well treatments work for the Canadian population.
Our Chosen Approach and Why
We’re using a method called “transportability analysis” to adapt the clinical trial results to new populations. Following a thorough review of the literature, we’ve chosen this approach because it allows us to systematically adjust the trial data based on population differences in a way that other methods might miss. We’ll use Canadian survey data to represent our target population and make adjustments for provincial differences in population makeup. This approach is ideal for ensuring that the SURPASS-3 trial results are relevant to Canadians, giving us a more accurate picture of how the new medication, tirzepatide, might work in Canada.
Potential Outcomes and Impact
This research could lead to:
– More accurate treatment guidelines for Canadian patients with type 2 diabetes
– Improved understanding of how new diabetes medications might work in different Canadian provinces
– Better allocation of healthcare resources based on provincial needs
– Potential cost savings by identifying which treatments are most effective for specific populations
By tailoring diabetes care strategies to account for regional differences in Canada, we aim to improve outcomes for patients, potentially reducing complications and improving quality of life for millions of Canadians living with type 2 diabetes.
Requested Studies:
A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes
Data Contributor: Lilly
Study ID: NCT03882970
Sponsor ID: 16997
IPD Uploaded:
DOIs: Study DOI: DataPackage DOI:
I will bring my own statistical functions for g-computation. These are publicly available on our company GitHub: https://github.com/CoreClinicalSciences/TransportHealth
Data Contributor: I WILL BRING MY OWN
Sponsor ID: Script