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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 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]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“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]
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“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]
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“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]
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“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]
In the citing paper
“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: Standards of Care in Diabetes—2023 (2023) · cites this paper as [64]
In the citing paper
“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: Standards of Care in Diabetes—2023 (2023) · cites this paper as [64]
In the citing paper
“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: Standards of Care in Diabetes—2023 (2023) · cites this paper as [64]
In the citing paper
“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: Standards of Care in Diabetes—2023 (2023) · cites this paper as [64]
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Gaps and barriers in the control of blood glucose in people with type 2 diabetes
Blonde, L., Aschner, P. J., Bailey, C. J., Ji, L., Leiter, L. A., Matthaei, S., & Management, O. B. O. T. G. P. F. E. D. (2017) · Diabetes and Vascular Disease Research · doi:10.1177/1479164116679775 · Cited by 160
Dunlay, S. M., Givertz, M. M., Aguilar, D., Allen, L. A., Chan, M., Desai, A. S., Deswal, A., Dickson, V. V., Kosiborod, M. N., Lekavich, C. L., et al. (2019) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2019.05.007 · Cited by 145
Cardiovascular Disease and Type 2 Diabetes: Has the Dawn of a New Era Arrived?
Abdul-Ghani, M. A., DeFronzo, R. A., Prato, S. D., CHILTON, R. J., Singh, R., & Ryder, R. E. J. (2017) · Diabetes Care · doi:10.2337/dc16-2736 · Cited by 146
“Moreover, in theUnited KingdomProspective Diabetes Study (UKPDS) (11) and Veterans Affairs Diabetes Trial (VADT) (12), it took10 years to observe the CV benefit associated with improved glycemic control.”
BackgroundInfluentialDhatariya, K., Bain, S. C., Buse, J. B., Simpson, R., Tarnow, L., Kaltoft, M. S., Stellfeld, M., Tornøe, K., Pratley, R. E., & the LEADER Publication Committee on behalf of the LEADER Trial Investigators (2018) · Diabetes Care · doi:10.2337/dc18-1094 · Cited by 141
“In the Veterans Affairs Diabetes Trial (VADT), amputation due to ischemic gangrene was included within the composite primary end point, but data related to amputation or foot ulcers only do not appear to have been published (22,23).”
BackgroundInflammation, glucose, and vascular cell damage: the role of the pentose phosphate pathway
Peiró, C., Romacho, T., Azcutia, V., Villalobos, L. A., Fernández, E., Bolaños, J. P., Moncada, S., & Sánchez‐Ferrer, C. F. (2016) · Cardiovascular Diabetology · doi:10.1186/s12933-016-0397-2 · Cited by 147
Epigenetic Changes in Diabetes and Cardiovascular Risk
Keating, S. T., Plutzky, J., & El-Osta, A. (2016) · Circulation Research · doi:10.1161/circresaha.116.306819 · Cited by 139
Zhou, Z., Liu, Q., Zheng, M., Zuo, Z., Zhang, G., Shi, R., & Wu, T. (2024) · Cardiovascular Diabetology · doi:10.1186/s12933-024-02308-w · Cited by 143
Glycemic Variation and Cardiovascular Risk in the Veterans Affairs Diabetes Trial
Zhou, J. J., Schwenke, D. C., Bahn, G., & Reaven, P. (2018) · Diabetes Care · doi:10.2337/dc18-0548 · Cited by 131
Self-citationDurante, W., Behnammanesh, G., & Peyton, K. J. (2021) · International Journal of Molecular Sciences · doi:10.3390/ijms22168786 · Cited by 135
“Intriguingly, the reduction of adverse cardiovascular events occurs rapidly following the start of therapy, suggesting that mechanisms other than improvements in hyperglycemia are responsible for this effect as glycemic control requires years to have a measureable impact [41,42].”
BackgroundInfluentialPlatelets Express Activated P2Y 12 Receptor in Patients With Diabetes Mellitus
Hu, L., Chang, L., Zhang, Y., Zhai, L., Zhang, S., Qi, Z., Yan, H., Yan, Y., Luo, X., Zhang, S., et al. (2017) · Circulation · doi:10.1161/circulationaha.116.026995 · Cited by 134
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6. Glycemic Goals, Hypoglycemia, and Hyperglycemic Crises: Standards of Care in Diabetes-2026.
American Diabetes Association Professional Practice Committee for Diabetes*, Bajaj, M., McCoy, R. G., Balapattabi, K., Bannuru, R. R., Bellini, N. J., Bennett, A. K., Beverly, E. A., Briggs Early, K., ChallaSivaKanaka, S., et al. (2026) · Diabetes Care · doi:10.2337/dc26-s006 · Cited by 172
2023 Clinical Practice Guidelines for Diabetes Mellitus of the Korean Diabetes Association
Choi, J. H., Lee, K. A., Moon, J. H., Chon, S., Kim, D. J., Kim, H. J., Kim, N. H., Seo, J. A., Kim, M. K., Lim, J. H., et al. (2023) · Diabetes & Metabolism Journal · doi:10.4093/dmj.2023.0282 · Cited by 130
“In patients with a long duration of diabetes, a history of severe hypoglycemia, advanced diabetic complications, short life expectancy, or advanced age, consideration should be given to setting lower glycemic control targets [12-14].”
BackgroundInsulin Therapy Increases Cardiovascular Risk in Type 2 Diabetes
Herman, M. E., O’Keefe, J. H., Bell, D. S. H., & Schwartz, S. S. (2017) · Progress in Cardiovascular Diseases · doi:10.1016/j.pcad.2017.09.001 · Cited by 123
Genetics Insights in the Relationship Between Type 2 Diabetes and Coronary Heart Disease
Goodarzi, M. O., & Rotter, J. I. (2020) · Circulation Research · doi:10.1161/circresaha.119.316065 · Cited by 119
Palta, P., Huang, E. S., Kalyani, R. R., Golden, S. H., & Yeh, H. (2017) · Diabetes Care · doi:10.2337/dci16-0042 · Cited by 117
“these and other trials have also shown benefits with respect to cardiovascular events and mortality (6,7).”
BackgroundA Unified Pathophysiological Construct of Diabetes and its Complications
Schwartz, S. S., Epstein, S., Corkey, B. E., Grant, S. F. A., Gavin, J. R., Aguilar, R. B., & Herman, M. E. (2017) · Trends in Endocrinology and Metabolism · doi:10.1016/j.tem.2017.05.005 · Cited by 117
Imran, S. A., Agarwal, G., Bajaj, H. S., & Ross, S. (2018) · Canadian Journal of Diabetes · doi:10.1016/j.jcjd.2017.10.030 · Cited by 113
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“This data provides evidence that a current multidrug glycemic treatment regimen (which includes glimepiride) can be associated with a significant reduction in major macrovascular events even among older patients who have had diabetes for many years.[62] The major outcomes of treatment with SUs in landmark trials have…”
Glucose targets for preventing diabetic kidney disease and its progression
Ruospo, M., Saglimbene, V. M., Palmer, S. C., De Cosmo, S., Pacilli, A., Lamacchia, O., Cignarelli, M., Fioretto, P., Vecchio, M., Craig, J. C., et al. (2017) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd010137.pub2 · Cited by 111
Alatorre, C., Fernández Landó, L., Yu, M., Brown, K., Montejano, L., Juneau, P., Mody, R., & Swindle, R. (2017) · Diabetes, Obesity and Metabolism · doi:10.1111/dom.12902 · Cited by 111
Cardiovascular protection by SGLT2 inhibitors – Do anti-inflammatory mechanisms play a role?
Elrakaybi, A., Laubner, K., Zhou, Q., Hug, M. J., & Seufert, J. (2022) · Molecular Metabolism · doi:10.1016/j.molmet.2022.101549 · Cited by 118
Prediabetes Is Associated With Structural Brain Abnormalities: The Maastricht Study
van Agtmaal, M. J. M., Houben, A. J. H. M., de Wit‐Verheggen, V. H. W., Henry, R. M. A., Schaper, N. C., Dagnelie, P. C., Kallen, C., Koster, A., Sep, S. J. S., Kroon, A. A., et al. (2018) · Diabetes Care · doi:10.2337/dc18-1132 · Cited by 112
Yale, J.-F., Paty, B., & Senior, P. A. (2018) · Canadian Journal of Diabetes · doi:10.1016/j.jcjd.2017.10.010 · Cited by 105
Systematic review of palm oil consumption and the risk of cardiovascular disease
Ismail, S. R., Maarof, S. K., Ali, S. S., & Ali, A. (2018) · PLoS ONE · doi:10.1371/journal.pone.0193533 · Cited by 110
‘Smart’ insulin-delivery technologies and intrinsic glucose-responsive insulin analogues
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Real-world assessments of mySugr mobile health app
Debong, F., Mayer, H., & Kober, J. (2019) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2019.0019 · Cited by 95
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Kalra, S., Bahendeka, S., Sahay, R., Ghosh, S., Md, F., Orabi, A., Ramaiya, K., Al Shammari, S., Shrestha, D., Shaikh, K., et al. (2018) · Indian Journal of Endocrinology and Metabolism · doi:10.4103/ijem.ijem_556_17 · Cited by 101
“6 years) reported that GLIM-based intensive regimen was associated with a 17% relative risk reduction in the rate of CV events compared to standard therapy.[13] Moreover, a recent meta-analysis demonstrates that SUs are not associated with increased risk for all-cause mortality, CV mortality, MI, or stroke.”
BackgroundResultReardon, C. A., Lingaraju, A., Schoenfelt, K. Q., Zhou, G., Cui, C., Jacobs-El, H., Babenko, I., Hoofnagle, A. N., Czyż, D. M., Shuman, H. A., et al. (2018) · Cell Reports · doi:10.1016/j.celrep.2018.05.010 · Cited by 102
“While elevated HBA1c levels are an excellent predictor of atherosclerotic risk, therapeutically lowering HBA1c does not necessarily alleviate this risk (Hayward et al., 2015).”
BackgroundBoye, K. S., Thieu, V. T., Lage, M. J., Miller, H., & Paczkowski, R. (2022) · Advances in Therapy · doi:10.1007/s12325-022-02106-4 · Cited by 99
Luk, A. O. Y., Hui, E. M., Sin, M.-C., Yeung, C., Chow, W.-S., Ho, A. Y. Y., Hung, H.-F., Kan, E. C. Y., Ng, C., So, W. Y., et al. (2017) · Diabetes Care · doi:10.2337/dc16-2354 · Cited by 96
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“Furthermore, several randomized controlled studies of patients with type 2 DM have demonstrated that intensive glucose control was associated with a significant reduction in the rate of major cardiovascular events [47].”
BackgroundMurphy, M. E., Byrne, M., Galvin, R., Boland, F., Fahey, T., & Smith, S. M. (2017) · BMJ Open · doi:10.1136/bmjopen-2016-015135 · Cited by 94
“The relative importance of targeting glycaemic or cardiovascular risk has been debated in the literature.(17) We did not account for medication use in the studies, but given that all included studies were RCTs, which would balance out delivery of medications, we think that differences relating to underlying medication…”
BackgroundGoedeke, L., & Shulman, G. I. (2021) · Molecular Metabolism · doi:10.1016/j.molmet.2021.101178 · Cited by 102
for the VADT Study Group, Agrawal, L., Azad, N., Bahn, G. D., Ge, L., Reaven, P. D., Hayward, R. A., Reda, D. J., & Emanuele, N. V. (2018) · Diabetologia · doi:10.1007/s00125-017-4473-2 · Cited by 92
“At the VADT baseline we classified Kidney Disease: Improving Global Outcomes for chronic kidney disease (KDIGO-CKD) categories using eGFR in ml min−1 1.73 m−2 (estimated using the Modification of Diet in Renal Disease equation [see ESM Methods]) [8] and albumin to creatinine ratio (ACR) in mg/mmol as: low risk (eGFR >…”
InfluentialSelf-citationCardiovascular Protection by Sodium Glucose Cotransporter 2 Inhibitors: Potential Mechanisms
Staels, B. (2017) · The American Journal of Medicine · doi:10.1016/j.amjmed.2017.04.009 · Cited by 97
Metadata
- 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
- 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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