TrialSignal
Clinical trial intelligence report
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)
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT00069784-Jul 28, 2026
NCT ID
NCT00069784
Status
COMPLETED
Phase
Phase 3
Sponsor
Sanofi
Executive brief
Investment-Ready Snapshot
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.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT00069784
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.
Intervention
insulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), placebo, reusable pen device for insulin injection
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.