ORIGINALE (ORIGIN And Legacy Effects)

Several studies of people with diabetes have shown that long-term follow-up after large clinical outcomes trials have reported either: a) persistence of the cardiovascular effect of the intervention observed during the trial, or b) emergence of new cardiovascular effects that were not apparent during the trial. These effects were observed during the post-trial follow-up period and have been described as “legacy effects” of the intervention.

ORIGINALE (ORIGIN And Legacy Effects) is a prospective observational follow-up study to ORIGIN. The ORIGIN trial completed active follow-up in 2011, having collected more than 80,000 person years of follow-up in people with pre-diabetes and diabetes. ORIGINALE will carry on with ongoing simple follow-up of the ORIGIN participants for at least two years (until March 2014). ORIGINALE has the potential to identify long-term effects of the interventions, and once completed, will comprise the largest database of the longest-followed people with these characteristics.

This study will be conducted by the international network of ORIGIN investigators and led by PHRI.

Objectives

The primary questions to be answered are:

• a) does targeting a fasting plasma glucose level < 5.3 mmol/l with insulin glargine for a median duration of 6.2 years reduce cardiovascular morbidity and/or mortality after 8-9 years in people at high risk for vascular disease with either IFG, IGT, or early type 2 diabetes?
• b) do omega-3 polyunsaturated fatty acid supplements for a median duration of 6.2 years reduce cardiovascular mortality after 8-9 years in people at high risk for vascular disease with either IFG, IGT, or early type 2 diabetes?

The secondary questions are:

During a total of 8-9 years of follow-up in these people (6.2 years of active followed by 2 years of passive follow-up),

• a) does targeting a fasting plasma glucose level < 5.3 mmol/l with insulin glargine reduce: 1) clinically important eye or kidney disease; 2) serious cancers; or 3) new diabetes, versus standard care?
• b) do n-3 PUFA supplements reduce: 1) major vascular events (cardiovascular death, myocardial infarction, or stroke); or 2) a composite of sudden unexpected death, non-sudden arrhythmic death, unwitnessed death, or resuscitated cardiac arrest, versus placebo?

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