Follow-up of glycemic control and cardiovascular outcomes in type 2 diabetes
Open accessAbstract
BACKGROUND: The Veterans Affairs Diabetes Trial previously showed that intensive glucose lowering, as compared with standard therapy, did not significantly reduce the rate of major cardiovascular events among 1791 military veterans (median follow-up, 5.6 years). We report the extended follow-up of the study participants. METHODS: After the conclusion of the clinical trial, we followed participants, using central databases to identify procedures, hospitalizations, and deaths (complete cohort, with follow-up data for 92.4% of participants). Most participants agreed to additional data collection by means of annual surveys and periodic chart reviews (survey cohort, with 77.7% follow-up). The primary outcome was the time to the first major cardiovascular event (heart attack, stroke, new or worsening congestive heart failure, amputation for ischemic gangrene, or cardiovascular-related death). Secondary outcomes were cardiovascular mortality and all-cause mortality. RESULTS: The difference in glycated hemoglobin levels between the intensive-therapy group and the standard-therapy group averaged 1.5 percentage points during the trial (median level, 6.9% vs. 8.4%) and declined to 0.2 to 0.3 percentage points by 3 years after the trial ended. Over a median follow-up of 9.8 years, the intensive-therapy group had a significantly lower risk of the primary outcome than did the standard-therapy group (hazard ratio, 0.83; 95% confidence interval [CI], 0.70 to 0.99; P=0.04), with an absolute reduction in risk of 8.6 major cardiovascular events per 1000 person-years, but did not have reduced cardiovascular mortality (hazard ratio, 0.88; 95% CI, 0.64 to 1.20; P=0.42). No reduction in total mortality was evident (hazard ratio in the intensive-therapy group, 1.05; 95% CI, 0.89 to 1.25; P=0.54; median follow-up, 11.8 years). CONCLUSIONS: After nearly 10 years of follow-up, patients with type 2 diabetes who had been randomly assigned to intensive glucose control for 5.6 years had 8.6 fewer major cardiovascular events per 1000 person-years than those assigned to standard therapy, but no improvement was seen in the rate of overall survival. (Funded by the VA Cooperative Studies Program and others; VADT ClinicalTrials.gov number, NCT00032487.).
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Numerous studies have demonstrated the clinical benefits of early achievement of near-normal glycemic control in individuals with type 1 diabetes and type 2 diabetes.
“Numerous studies have demonstrated the clinical benefits of early achievement of nearnormal glycemic control in individuals with type 1 diabetes and type 2 diabetes (77-83).”
From Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range (2019) · cites this paper as [83]
The Discussion reports fewer major cardiovascular events with intensive glycemic therapy in people with type 2 diabetes, and p. 2198 describes favorable results from a study of newly diagnosed patients. But this paper’s own participants had lived with diabetes for an average of 11.5 years (p. 2201); it does not establish benefits from early achievement of near-normal control or address type 1 diabetes. (LLM, conf=0.88)
Experimental — accuracy not yet measuredPost-trial observational follow-up of the VADT over 10 years has also shown a significant reduction in the primary outcome of major cardiovascular disease events, with myocardial infarctions and heart failure being the most common outcomes.
“Post-trial observational follow-up of the VADT over 10 years has also shown a significant reduction in the primary outcome of major CVD events, with myocardial infarctions and heart failure being the most common outcomes (60).”
From 6. Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises: Standards of Care in Diabetes-2026. (2026) · cites this paper as [60]
The Primary Outcome and Secondary Outcomes section reports a significant reduction in major cardiovascular events after a median 9.8 years of follow-up (hazard ratio 0.83; P=0.04). The Primary and Secondary Outcomes section includes heart attacks and new or worsening heart failure in the composite, but our copy does not establish that they were the most common outcomes; it directs readers to supplementary tables for component results. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn the VADT, during an observational median follow-up of 9.8 years, the intensive-therapy group had a significantly lower risk of the primary outcome (HR 0.83, p=0.04), with an absolute reduction in risk of 8.6 major CV events per 1,000 person-years.
“However, during an observational median follow up of 9.8 years, the intensive-therapy group had a significantly lower risk of the primary outcome (MI, stroke, new or worsening congestive heart failure [CHF], amputation for ischemic gangrene, or CV-related death) than did the standard therapy group (HR 0.83, p=0.04), with an absolute reduction in risk of 8.6 major CV events per 1,000 personyears (”
From Targets for Glycemic Control (2018) · cites this paper as [27]
Longer-term epidemiological follow-up of these studies also showed a pattern of cardiovascular disease benefit.
“Additionally, longer-term epidemiological follow-up of these studies also showed a pattern of CVD benefit (58-60).”
From 6. Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises: Standards of Care in Diabetes-2026. (2026) · cites this paper as [60]
In people with type 2 diabetes and established or very high risk for cardiovascular disease, there is a clear association between increased mortality and severe hypoglycemia and symptomatic hypoglycemia.
“In people with type 2 diabetes and established, or very high risk for, cardiovascular disease (CVD), there is a clear association between an increased mortality and severe hypoglycemia (62,63) and symptomatic hypoglycemia (64).”
From Hypoglycemia (2018) · cites this paper as [62]
The cited paper's discussion of treatment harms (section headed “Table 1. Baseline Characteristics,” page not provided) mentions hypoglycemia as a possible side effect, while its mortality results compare intensive with standard glucose control. Neither passage examines whether symptomatic hypoglycemia is associated with increased mortality. Searches for “hypoglycemia” and “symptomatic hypoglycemia risk of death association” found no such analysis in our copy. (LLM, conf=0.77)
Experimental — accuracy not yet measured
Meta-analyses have clearly shown that tight blood glucose control leads to the suppression of ASCVD incidence.
“Meta-analyses have clearly shown that tight blood glucose control leads to the suppression of ASCVD incidence795, 796).”
From Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2017 (2018) · cites this paper as [795]
Ten-year follow-up of the VADT cohort showed no benefit in cardiovascular mortality.
“However, 10-year follow-up of the VADT cohort (64) did demonstrate a reduction in the risk of cardiovascular events (52.7 [control group] vs. 44.1 [intervention group] events per 1,000 person-years) with no benefit in cardiovascular or overall mortality.”
From 6. Glycemic Targets: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [64]
Ten-year follow-up of the VADT cohort demonstrated a reduction in the risk of cardiovascular events (52.7 control vs. 44.1 intervention events per 1,000 person-years).
“However, 10-year follow-up of the VADT cohort (64) did demonstrate a reduction in the risk of cardiovascular events (52.7 [control group] vs. 44.1 [intervention group] events per 1,000 person-years) with no benefit in cardiovascular or overall mortality.”
From 6. Glycemic Targets: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [64]
Ten-year follow-up of the VADT cohort showed no benefit in overall mortality.
“However, 10-year follow-up of the VADT cohort (64) did demonstrate a reduction in the risk of cardiovascular events (52.7 [control group] vs. 44.1 [intervention group] events per 1,000 person-years) with no benefit in cardiovascular or overall mortality.”
From 6. Glycemic Targets: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [64]
In ACCORD, ADVANCE, and VADT, severe hypoglycemia was significantly more likely in participants randomly assigned to the intensive glycemic control arm.
“In all three trials, severe hypoglycemia was significantly more likely in participants who were randomly assigned to the intensive glycemic control arm.”
From 6. Glycemic Targets: <i>Standards of Care in Diabetes—2023</i> (2023) · cites this paper as [64]
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- Authors
- Hayward, R. A., Reaven, P. D., Wiitala, W. L., Bahn, G. D., Reda, D. J., Ge, L., McCarren, M., Duckworth, W. C., & Emanuele, N. V.
- Affiliations
- Edward Hines, Jr. VA Hospital (US)
- Phoenix VA Health Care System (US)
- VA Ann Arbor Healthcare System (US)
- Veterans Health Administration (US)
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-06-04
- Volume
- 372
- Issue
- 23
- Pages
- 2197-2206
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2153552938
- Cited by
- 668
- References
- 27
- Citations by year
- 2026: 14 · 2025: 23 · 2024: 30 · 2023: 47 · 2022: 28 · 2021: 53 · 2020: 60 · 2019: 77 · 2018: 73 · 2017: 105 · 2016: 113 · 2015: 44 · 2014: 1
- FWCI
- 97.07
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Department of Veterans Affairs (98‐004)
- Amgen
- AstraZeneca
- Health Services Research and Development
- Novo Nordisk
- National Institutes of Health (98-004)
- National Heart, Lung, and Blood Institute (R01HL067690, R01HL094775)
- National Institute of Diabetes and Digestive and Kidney Diseases (P30DK092926)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- type 2 diabetes, tight glycemic control, glycemic control, HbA1c, major cardiovascular events, cardiovascular mortality, all-cause mortality, military veterans, long-term follow-up, cardiovascular risk reduction, congestive heart failure, amputation, stroke, myocardial infarction, ischemic gangrene
- MeSH terms
- Aged, Blood Glucose, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Female, Follow-Up Studies, Glycated Hemoglobin, Humans, Hypoglycemic Agents, Male, Middle Aged, Risk, Survival Analysis
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