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Efficacy of Glucose-Lowering Drugs for Young-Onset Type 2 Diabetes: A Meta-Analysis of Individual Participant Data from Randomized Control Trials
Proposal
12500
Title of Proposed Research
Efficacy of Glucose-Lowering Drugs for Young-Onset Type 2 Diabetes: A Meta-Analysis of Individual Participant Data from Randomized Control Trials
Lead Researcher
Dr. Calvin Ke
Affiliation
Toronto General Hospital, University Health Network Director, Epidemiologic and Applied Research Lab in Young-Onset Diabetes (EARLY Diabetes) Assistant Professor, Department of Medicine, University of Toronto
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
13 January 2025
Lay Summary
People diagnosed with type 2 diabetes before the age of 40 are categorized as having young-onset diabetes, while the remainder are classified as usual-onset diabetes. Young-onset diabetes is increasingly prevalent worldwide and tends to be more aggressive than usual-onset diabetes. Those with young-onset diabetes often experience hospitalizations due to heart attacks, kidney disease, and other serious complications, leading to premature death, usually about 14 years earlier than those without diabetes. Managing high blood sugar is crucial to preventing or delaying these outcomes.Despite the necessity for medications to control blood sugar levels in young-onset diabetes, there's a limited understanding of how effective these drugs are for this demographic, as they've been underrepresented in previous studies. To bridge this knowledge gap, our aim is to assess the efficacy of common blood sugar-lowering drugs (including metformin, sulfonylureas, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter type 2 inhibitors, glucagon-like peptide-1 receptor agonists, and thiazolidinediones) in young-onset diabetes compared to usual-onset diabetes. We anticipate that certain medications will lower blood sugar especially well in young-onset diabetes. We will collect data from past studies that tested these drugs using an online research database with comprehensive records from numerous previous drug trials. We will use a special method to pool together data from all available studies to gather enough people with young-onset diabetes. By combining datasets, we can analyze the data in a more powerful way than by considering each study in isolation. Advanced statistical computer programs will be used to compare how individuals with young-onset diabetes respond to the different drug types compared to usual-onset diabetes, by comparing their blood sugar levels at various time points after taking each drug. This analysis will be conducted separately for each of the drug types of interest. The findings of this research will offer valuable insights to assist doctors in tailoring prescriptions specifically for young-onset diabetes. Identifying the most effective drugs has the potential to enhance blood sugar management, thereby reducing hospitalizations, mitigating severe consequences associated with young-onset diabetes, and ultimately improving the overall health and longevity of individuals living with this condition.
Study Data Provided
[{ "PostingID": 20886, "Title": "NOVARTIS-CLAF237B2224", "Description": "A multi-center, randomized, double-blind study to evaluate the efficacy and long-term safety of vildagliptin modified release (MR) as add-on therapy to metformin in patients with type 2 diabetes" },{ "PostingID": 20893, "Title": "NOVARTIS-CLAF237A2305", "Description": "A multicenter, double-blind, randomized, parallel-group study to compare the effect of 24 weeks treatment with LAF237 (50 mg qd or bid) to placebo as add-on therapy to glimepiride in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy" },{ "PostingID": 21110, "Title": "NOVARTIS-CLAF237A1303", "Description": "A Study To Compare the Effect of Vildagliptin Compared to Placebo in Patients With Type 2 Diabetes" },{ "PostingID": 21111, "Title": "NOVARTIS-CLAF237A2301", "Description": "A Clinical Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes" },{ "PostingID": 21112, "Title": "NOVARTIS-CLAF237ADE02", "Description": "Vildagliptin 100 mg Once Daily vs. Placebo as add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin" }]
Statistical Analysis Plan
Publication Citation
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