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An individual participant data meta-analysis to evaluate a new category of hypoglycemic drugs (GLP-1RAs) on type 2 diabetes mellitus patient sub-groups

An individual participant data meta-analysis to evaluate a new category of hypoglycemic drugs (GLP-1RAs) on type 2 diabetes mellitus patient sub-groups

Feng Sun

School of public health, Peking University

02 August 2021

Diabetes is a group of metabolic diseases characterized by hyperglycemia. Type 2 diabetes mellitus (T2DM) where the body does not produce enough insulin by the pancreas to turn glucose into energy, is the most common type of diabetes. Glucagon-like-peptide-1 receptor agonist (GLP-1RAs) is a series of drugs that stimulate insulin secretion by the pancreas to enable cells to use blood sugar (glucose) as energy to decrease the blood sugar. We'd like to conduct a sets of individual participant data (IPD) meta-analysis to compare and summarize the efficacy and safety of GLP-1RAs in subgroups of T2DM patients. For instance, hypoglycemic effects - low glucose in the bloodstream resulting in headache, fatigue, vomiting, excessive hunger and thirst, rapid heartbeat, vision problems and other symptoms- are one of the most common side effects of hypoglycemic drugs. We assumed that the hypoglycemic effects of this new type of hypoglycemic agents may be different among patients with different ages, races, baseline body weights, and baseline level of glycated hemoglobin (HbA1c)- a measurement of average blood sugar, while the risk of causing complications also may differ among patients with different baseline disease conditions or different family histories, etc. For every outcome we concerned, we will extract a certain subgroup from each included randomized controlled trials (RCTs). After calculating the mean of the outcome indicator and its standard deviation or the incidence of the outcome event for each individual trial, we will pool the results following a traditional random-effects model meta-analysis. Detailed statistical analysis method will be showed in the “Statistical Analysis Plan” section below. After conducting a series of analysis on each outcome, we expect to comprehensively evaluate the efficacy and safety of this type of new drugs in different subgroups.

[{ "PostingID": 3701, "Title": "GSK-GLP107865", "Description": "Clinical assessment of GSK716155 for Type 2 Diabetes Mellitus
 -A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus" },{ "PostingID": 4217, "Title": "GSK-GLP113121", "Description": "A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Monotherapy Study to Determine the Efficacy and Safety of 2 Dose Levels of Albiglutide in Subjects with Type 2 Diabetes Mellitus" },{ "PostingID": 4631, "Title": "GSK-GLP116170", "Description": "A 52-Week, Open-Label, Multicenter Study to Determine the Long Term Safety and Efficacy of Albiglutide in Combination with Monotherapy of Oral Antihyperglycemic Medications in Japanese Patients With Type 2 Diabetes Mellitus" },{ "PostingID": 4729, "Title": "SANOFI-EFC11321", "Description": "Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (With or Without Sulfonylurea): a Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study With 24-week Treatment Period / GetGoal-M-Asia" }]

Statistical Analysis Plan