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# FDA Eliminates CV Outcomes Data on Diabetes Drugs
- URL: https://www.fdaweb.com/fda-eliminates-cv-outcomes-data-on-diabetes-drugs/
- Published: 2020-03-09T12:00:00.000Z
- Updated: 2026-09-14T16:06:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146276

FDA has issued a new draft guidance on “[Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control](https://www.federalregister.gov/documents/2020/03/10/2020-04877/guidance-type-2-diabetes-mellitus-evaluating-the-safety-of-new-drugs-for-improving-glycemic-control?ref=fdaweb.com)” that proposes to remove a previous recommendation that sponsors of all new therapies for Type 2 diabetes uniformly rule out risks for ischemic cardiovascular adverse outcomes (cardiovascular outcome trials). It recommends broad pre-approval safety evaluations that examine beyond ischemic (reduced blood flow) cardiovascular disease. The guidance also proposes a broader scope of human subjects, such as older subjects and those with chronic kidney disease who may be more vulnerable to drug-related side effects, to include in clinical trials.

“By following previous FDA recommendations, sponsors have shown that new Type 2 diabetes drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients,” the [agency says ](https://www.fda.gov/news-events/press-announcements/fda-proposes-broad-approach-conducting-safety-trials-type-2-diabetes-medications?utm%5Fcampaign=030920%5FPR%5FFDA%20proposes%20broad%20approach%20for%20safety%20trials%20for%20type%202%20diabetes&utm%5Fmedium=email&utm%5Fsource=Eloqua)in announcing the proposed recommendations. “Now, with this proposed approach, we will have broader, valuable safety information for these medications.” The policy shift was supported by FDA’s [Endocrinologic and Metabolic Drugs Advisory Committee](https://www.fda.gov/advisory-committees/advisory-committee-calendar/october-24-25-2018-meeting-endocrinologic-and-metabolic-drugs-advisory-committee-meeting?ref=fdaweb.com), which noted safety data beyond ischemic cardiovascular safety data was desired to evaluate the safety profile of antidiabetic drugs before they were approved.