A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
The ORIGIN trial, sponsored by Sanofi, addresses significant unmet needs in the management of cardiovascular risks associated with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and early type 2 diabetes mellitus. With an enrollment of over 12,500 participants across 40 countries, the trial's findings could reinforce the therapeutic positioning of insulin glargine and omega-3 fatty acids in a competitive diabetes and cardiovascular market. The results may support expanded indications for these agents, potentially enhancing market share against competitors like Novo Nordisk and Eli Lilly, which also target similar patient populations. The trial's completion and subsequent data readouts will be critical for informing market access strategies and reimbursement discussions.
Indication: Diabetes Mellitus, Non-Insulin-Dependent
Modality: medical device
Target: Insulin glargine (HOE901) and omega-3 polyunsaturated fatty acids (PUFA) targeting cardiovascular morbidity and mortality in patients with impaired glucose metabolism.
Sponsor: Sanofi
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 22, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Insulin glargine (HOE901) and omega-3 polyunsaturated fatty acids (PUFA) targeting cardiovascular morbidity and mortality in patients with impaired glucose metabolism.
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Condition raw: Diabetes Mellitus, Non-Insulin-Dependent
Condition normalized: Diabetes Mellitus, Non-Insulin-Dependent
Modality raw: medical device
Modality normalized: medical device
Target raw: Insulin glargine (HOE901) and omega-3 polyunsaturated fatty acids (PUFA) targeting cardiovascular morbidity and mortality in patients with impaired glucose metabolism.
Target normalized: Insulin glargine (HOE901) and omega-3 polyunsaturated fatty acids (PUFA) targeting cardiovascular morbidity and mortality in patients with impaired glucose metabolism.