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  • American Diabetes Association  (19)
  • 1
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    9-LB: Hypoglycemia in Patients with Diabetes: Therapeutic Strategies and Associated Risk Factors
    American Diabetes Association ; 2019
    In:  Diabetes Vol. 68, No. Supplement_1 ( 2019-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 68, No. Supplement_1 ( 2019-06-01)
    Abstract: Use of insulin or sulfonylureas (SU) carries a risk of hypoglycemia, but the risk with different diabetes therapies, such as premixed insulin, is not well known. We conducted a case-control analysis of 297,263 patients with DIAB and 487,226 NONDIAB in the national VA database who had ≥4 primary care visits, ≥1 A1c, and ≥3 outpatient random plasma glucoses (RPG) in 2002-2003, and examined hypoglycemia by diabetic medication use and other risk factors, through 2012. Hypoglycemia was defined as severe (Emergency Department visit with hypoglycemia [EDHypo]) and by outpatient lab (RPGHypo = RPG & lt;70 mg/dl); both were associated with increased mortality (2.1- and 1.5-fold, respectively, p & lt;0.001). At baseline, DIAB had mean age 66 year, BMI 31 kg/m2, and A1c 7.5%; and were 98% male, 80% white, and 18% with retinopathy; NONDIAB were similar but had lower BMI. Among DIAB, 49% were on SU, 29% insulin (5% basal, 5% basal+SU, 1% bolus, 8% basal+bolus, 10% premixed), 11% otherRx (non-insulin/non-SU), 11% no meds. RPGHypo and EDHypo occurred in 6.8% and 0.3% of DIAB, respectively, vs. 2.1% and & lt;0.1% of NONDIAB, p & lt;0.001. During mean follow-up 7.5 year, 35% of DIAB (n=102,063; 229,612 events) had ≥1 RPGHypo, an incidence rate of 0.10 events/pt-year, and 4% had EDHypo. In adjusted models compared to otherRx, the risk of any hypo and EDHypo, respectively, was highest with basal+bolus (OR 1.4 and 17.8) and premixed insulin (OR 1.4 and 13.8), and lower with basal Insulin (OR 1.4 and 10.5), and SU (OR 1.2 and 5.1), all p & lt;0.001. Black race and retinopathy also conferred higher risk of both any hypoglycemia and EDHypo (black race, OR 1.9 and 2.1; retinopathy OR 1.3 and 1.6, respectively; all p & lt;0.001), much higher than the risk with A1c & lt;6.0% (OR 1.0 and 1.3). Conclusions: Clinically significant hypoglycemia, including both outpatient RPG & lt;70 mg/dl and ED visits, is common in DIAB patients, particularly in those using basal+bolus or premixed insulin, and with black race or retinopathy, and should prompt consideration of altered management. Disclosure S.C. Markley Webster: Stock/Shareholder; Self; Dexcom, Inc. K.E. Kurgansky: None. L.S. Phillips: Advisory Panel; Self; Janssen Pharmaceuticals, Inc. Research Support; Self; AbbVie Inc., GlaxoSmithKline plc., Kowa Pharmaceutical Europe Co. Ltd., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Pfizer Inc. Stock/Shareholder; Self; Diasyst Inc. Other Relationship; Self; Diasyst Inc., Janssen Pharmaceuticals, Inc. D.R. Gagnon: None. P.W. Wilson: None. M.K. Rhee: None. Funding Million Veteran Program
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db19-9-LB
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 2
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    Hypoglycemia Contributes to Increased CVD Mortality with HbA1c 〈6.0%
    American Diabetes Association ; 2018
    In:  Diabetes Vol. 67, No. Supplement_1 ( 2018-07-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: Better diabetes control generally reduces development of complications, but those with HbA1c & lt;6.0% have increased cardiovascular (CVD) mortality. Since the cause is unknown, we studied the potential contributions of hypoglycemia, using VA and Medicare databases. 297,263 Veterans with diabetes (ICD-9 codes and diabetes Rx) had ≥4 primary care provider (PCP) visits in 2002-2003, baseline data including age, sex, race, ethnicity, BMI, non-HDL cholesterol, systolic blood pressure (sBP), smoking, ≥1 HbA1c, ≥3 outpatient random plasma glucose (RPG) levels, follow-up through 2012, and survived at least 1 year after A1c measurement. The 40,429 with A1c & lt;6.0% (A1c & lt;6) had mean age 66 year, were 98% male, 16% black and 6.5% Hispanic, had BMI 31, eGFR 71, sBP 139, 81% ever smoked, 51% had CVD at baseline, 48% used sulfonylureas and 13% insulin, with mean HbA1c 5.5%, and RPG 125 mg/dl, while 90,574 with HbA1c 6.0-6.9% (A1c6-6.9) had HbA1c 6.5% and RPG 141 (both p & lt;0.001), but were otherwise clinically comparable. In fully adjusted Cox proportional hazard models, A1c & lt;6 had increased CVD mortality compared to A1c6-6.9 (HR 1.07, p & lt;0.001). However, within 1 year after baseline, A1c & lt;6 also had increased frequency of both outpatient RPG & lt;70 (8.4% vs. 6.0%, p & lt;0.001), outpatient point of care glucose (POCG) & lt;70 (0.34% vs. 0.29%, p=ns), and emergency visits with hypoglycemia (EDHYPO, 0.28% vs. 0.24%, p=ns). Moreover, in Cox models including HbA1c ( & lt;6.0 -6.9, -7.9, -8.9, ≥9.0%), hypoglycemia measured by (i) outpatient RPG or POCG levels & lt;70 or (ii) EDHYPO, was independently associated with increased CVD mortality, fully adjusted HR 1.18 and 1.49, both p & lt;0.001. At all HbA1c levels, RPG or POCG & lt;70 predicted CVD mortality more consistently than EDHYPO. Conclusion: Hypoglycemia-associated CVD mortality occurs in general clinical practice-especially with outpatient glucose & lt;70 mg/dl-and increased mortality with HbA1c & lt;6.0% may be due in part to hypoglycemia. Management should be aimed to optimize control but limit the risk of hypoglycemia. Disclosure M. Rhee: None. K.E. Kurgansky: None. Y. Ho: None. D.R. Gagnon: None. S. Raghavan: None. J.L. Vassy: None. K. Cho: None. A. Gonzalez: None. F.N. Khan: None. L.R. Staimez: None. C.N. Ford: None. P.W. Wilson: None. L.S. Phillips: Other Relationship; Self; DIASYST Inc.. Research Support; Self; Amylin Pharmaceuticals, Eli Lilly and Company, Novo Nordisk Inc., Sanofi-Aventis, PhaseBio Pharmaceuticals, Inc., Roche Diabetes Care Health and Digital Solutions, AbbVie Inc., Vascular Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., GlaxoSmithKline plc., Pfizer Inc.. Other Relationship; Self; Novartis Pharmaceuticals Corporation, Merck & Co., Inc..
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db18-868-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
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  • 3
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    Optimization of Metformin in the GRADE Cohort: Effect on Glycemia and Body Weight
    American Diabetes Association ; 2020
    In:  Diabetes Care Vol. 43, No. 5 ( 2020-05-01), p. 940-947
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 43, No. 5 ( 2020-05-01), p. 940-947
    Abstract: We evaluated the effect of optimizing metformin dosing on glycemia and body weight in type 2 diabetes. RESEARCH DESIGN AND METHODS This was a prespecified analysis of 6,823 participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) taking metformin as the sole glucose-lowering drug who completed a 4- to 14-week (mean ± SD 7.9 ± 2.4) run-in in which metformin was adjusted to 2,000 mg/day or a maximally tolerated lower dose. Participants had type 2 diabetes for & lt;10 years and an HbA1c ≥6.8% (51 mmol/mol) while taking ≥500 mg of metformin/day. Participants also received diet and exercise counseling. The primary outcome was the change in HbA1c during run-in. RESULTS Adjusted for duration of run-in, the mean ± SD change in HbA1c was −0.65 ± 0.02% (−7.1 ± 0.2 mmol/mol) when the dose was increased by ≥1,000 mg/day, −0.48 ± 0.02% (−5.2 ± 0.2 mmol/mol) when the dose was unchanged, and −0.23 ± 0.07% (−2.5 ± 0.8 mmol/mol) when the dose was decreased (n = 2,169, 3,548, and 192, respectively). Higher HbA1c at entry predicted greater reduction in HbA1c (P & lt; 0.001) in univariate and multivariate analyses. Weight loss adjusted for duration of run-in averaged 0.91 ± 0.05 kg in participants who increased metformin by ≥1,000 mg/day (n = 1,894). CONCLUSIONS Optimizing metformin to 2,000 mg/day or a maximally tolerated lower dose combined with emphasis on medication adherence and lifestyle can improve glycemia in type 2 diabetes and HbA1c values ≥6.8% (51 mmol/mol). These findings may help guide efforts to optimize metformin therapy among persons with type 2 diabetes and suboptimal glycemic control.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc19-1769
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
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  • 4
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    Association of Baseline Characteristics With Insulin Sensitivity and β-Cell Function in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) Study Cohort
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 2 ( 2021-02-01), p. 340-349
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 2 ( 2021-02-01), p. 340-349
    Abstract: We investigated sex and racial differences in insulin sensitivity, β-cell function, and glycated hemoglobin (HbA1c) and the associations with selected phenotypic characteristics. RESEARCH DESIGN AND METHODS This is a cross-sectional analysis of baseline data from 3,108 GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) participants. All had type 2 diabetes diagnosed & lt;10 years earlier and were on metformin monotherapy. Insulin sensitivity and β-cell function were evaluated using the HOMA of insulin sensitivity and estimates from oral glucose tolerance tests, including the Matsuda Index, insulinogenic index, C-peptide index, and oral disposition index (DI). RESULTS The cohort was 56.6 ± 10 years of age (mean ± SD), 63.8% male, with BMI 34.2 ± 6.7 kg/m2, HbA1c 7.5 ± 0.5%, and type 2 diabetes duration 4.0 ± 2.8 years. Women had higher DI than men but similar insulin sensitivity. DI was the highest in Black/African Americans, followed by American Indians/Alaska Natives, Asians, and Whites in descending order. Compared with Whites, American Indians/Alaska Natives had significantly higher HbA1c, but Black/African Americans and Asians had lower HbA1c. However, when adjusted for glucose levels, Black/African Americans had higher HbA1c than Whites. Insulin sensitivity correlated inversely with BMI, waist-to-hip ratio, triglyceride-to-HDL-cholesterol ratio (TG/HDL-C), and the presence of metabolic syndrome, whereas DI was associated directly with age and inversely with BMI, HbA1c, and TG/HDL-C. CONCLUSIONS In the GRADE cohort, β-cell function differed by sex and race and was associated with the concurrent level of HbA1c. HbA1c also differed among the races, but not by sex. Age, BMI, and TG/HDL-C were associated with multiple measures of β-cell function and insulin sensitivity.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc20-1787
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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  • 5
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    Islet Autoimmunity Is Highly Prevalent and Associated With Diminished β-Cell Function in Patients With Type 2 Diabetes in the GRADE Study
    American Diabetes Association ; 2022
    In:  Diabetes Vol. 71, No. 6 ( 2022-06-01), p. 1261-1271
    Details
    In: Diabetes, American Diabetes Association, Vol. 71, No. 6 ( 2022-06-01), p. 1261-1271
    Abstract: Islet autoimmunity may contribute to β-cell dysfunction in type 2 diabetes (T2D). Its prevalence and clinical significance have not been rigorously determined. In this ancillary study to the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), we investigated the prevalence of cellular and humoral islet autoimmunity in patients with T2D duration of 4.0 ± 3.0 years (HbA1c 7.5 ± 0.5% on metformin alone). We measured T-cell autoreactivity against islet proteins, islet autoantibodies against 65-kDa GAD antigen, IA-2, and zinc transporter-8, and β-cell function. Cellular islet autoimmunity was present in 41.3%, humoral islet autoimmunity in 13.5%, and both in 5.3%. β-Cell function calculated as incremental area under the curve of glucose from 0–120 min (iAUC-CG) and ΔC-peptide(0–30)/Δglucose(0–30) from an oral glucose tolerance test was lower among T-cell–positive (T+) than T-cell–negative (T−) individuals using two different adjustments for insulin sensitivity (iAUC-CG: 13.2% [95% CI 0.3, 24.4] or 11.4% [95% CI 0.4, 21.2] lower; ΔC-peptide[0–30]/Δglucose[0–30] : 19% [95% CI 3.1, 32.3] or 17.7% [95% CI 2.6, 30.5%] lower). T+ patients had 17% higher HbA1c (95% CI 0.07, 0.28) and 7.7 mg/dL higher fasting plasma glucose levels (95% CI 0.2, 15.3) than T− patients. We conclude that islet autoimmunity is much more prevalent in patients with T2D than previously reported. T-cell–mediated autoimmunity is associated with diminished β-cell function and worse glycemic control.
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db21-0590
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2022
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  • 6
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    Association of Glycemia, Lipids, and Blood Pressure With Cognitive Performance in People With Type 2 Diabetes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 10 ( 2021-10-01), p. 2286-2292
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 10 ( 2021-10-01), p. 2286-2292
    Abstract: Type 2 diabetes is a risk factor for cognitive impairment. We examined the relation of glycemia, lipids, blood pressure (BP), hypertension history, and statin use with cognition in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). RESEARCH DESIGN AND METHODS Cross-sectional analyses from GRADE at baseline examined the association of glycemia (hemoglobin A1c [HbA1c]), LDL, systolic BP (SBP) and diastolic BP (DBP), hypertension history, and statin use with cognition assessed by the Spanish English Verbal Learning Test, letter and animal fluency tests, and Digit Symbol Substitution Test (DSST). RESULTS Among 5,047 GRADE participants, 5,018 (99.4%) completed cognitive assessments. Their mean age was 56.7 ± 10.0 years, and 36.4% were women. Mean diabetes duration was 4.0 ± 2.7 years. HbA1c was not related to cognition. Higher LDL was related to modestly worse DSST scores, whereas statin use was related to modestly better DSST scores. SBP between 120 and 139 mmHg and DBP between 80 and 89 mmHg were related to modestly better DSST scores. Hypertension history was not related to cognition. CONCLUSIONS In people with type 2 diabetes of a mean duration of & lt;5 years, lower LDL and statin use were related to modestly better executive cognitive function. SBP levels in the range of 120–139 mmHg and DBP levels in the range of 80–89 mmHg, but not lower levels, were related to modestly better executive function. These differences may not be clinically significant.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc20-2858
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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  • 7
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    Baseline Characteristics of Randomized Participants in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE)
    American Diabetes Association ; 2019
    In:  Diabetes Care Vol. 42, No. 11 ( 2019-11-01), p. 2098-2107
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 42, No. 11 ( 2019-11-01), p. 2098-2107
    Abstract: GRADE (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is a 36-center unmasked, parallel treatment group, randomized controlled trial evaluating four diabetes medications added to metformin in people with type 2 diabetes (T2DM). We report baseline characteristics and compare GRADE participants to a National Health and Nutrition Examination Survey (NHANES) cohort. RESEARCH DESIGN AND METHODS Participants were age ≥30 years at the time of diagnosis, with duration of T2DM & lt;10 years, HbA1c 6.8–8.5% (51–69 mmol/mol), prescribed metformin monotherapy, and randomized to glimepiride, sitagliptin, liraglutide, or insulin glargine. RESULTS At baseline, GRADE’s 5,047 randomized participants were 57.2 ± 10.0 years of age, 63.6% male, with racial/ethnic breakdown of 65.7% white, 19.8% African American, 3.6% Asian, 2.7% Native American, 7.6% other or unknown, and 18.4% Hispanic/Latino. Duration of diabetes was 4.2 ± 2.8 years, with mean HbA1c of 7.5 ± 0.5% (58 ± 5.3 mmol/mol), BMI of 34.3 ± 6.8 kg/m2, and metformin dose of 1,944 ± 204 mg/day. Among the cohort, 67% reported a history of hypertension, 72% a history of hyperlipidemia, and 6.5% a history of heart attack or stroke. Applying GRADE inclusion criteria to NHANES indicates enrollment of a representative cohort with T2DM on metformin monotherapy (NHANES cohort average age, 57.9 years; mean HbA1c, 7.4% [57 mmol/mol]; BMI, 33.2 kg/m2; duration, 4.2 ± 2.5 years; and 7.2% with a history of cardiovascular disease). CONCLUSIONS The GRADE cohort represents patients with T2DM treated with metformin requiring a second diabetes medication. GRADE will inform decisions about the clinical effectiveness of the addition of four classes of diabetes medications to metformin.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc19-0901
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 8
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    Disparities in Hemoglobin A1c Testing During the Transition to Adulthood and Association With Diabetes Outcomes in Youth-Onset Type 1 and Type 2 Diabetes: The SEARCH for Diabetes in Youth Study
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 10 ( 2021-10-01), p. 2320-2328
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 10 ( 2021-10-01), p. 2320-2328
    Abstract: To identify correlates of hemoglobin A1c (HbA1c) testing frequency and associations with HbA1c levels and microvascular complications in youth-onset diabetes. RESEARCH DESIGN AND METHODS The SEARCH for Diabetes in Youth study collected data from individuals diagnosed with diabetes before age 20 at 8 years (n = 1,885 type 1, n = 230 type 2) and 13 years (n = 649 type 1, n = 84 type 2) diabetes duration. We identified correlates of reporting ≥3 HbA1c tests/year using logistic regression. We examined associations of HbA1c testing with HbA1c levels and microvascular complications (retinopathy, neuropathy, or nephropathy) using sequentially adjusted linear and logistic regression. RESULTS For type 1 diabetes, odds of reporting ≥3 HbA1c tests/year at 8 and 13 years diabetes duration decreased with older age at diagnosis (odds ratio [OR] 0.91 [95% CI 0.88–0.95] ), longer duration of diabetes (OR 0.90 [0.82–0.99]), not having a personal doctor (OR 0.44 [0.30–0.65] ), and lapses in health insurance (OR 0.51 [0.27–0.96]). HbA1c testing ≥3 times/year over time was associated with lower HbA1c levels (OR −0.36% [−0.65 to −0.06] ) and lower odds of microvascular complications (OR 0.64 [0.43–0.97]) at 13 years’ duration, but associations were attenuated after adjustment for HbA1c testing correlates (OR −0.17 [−0.46 to 0.13] and 0.70 [0.46–1.07], respectively). For type 2 diabetes, not seeing an endocrinologist decreased the odds of reporting ≥3 HbA1c tests/year over time (OR 0.19 [0.06–0.63] ), but HbA1c testing frequency was not associated with HbA1c levels or microvascular complications. CONCLUSIONS We observed disparities in HbA1c testing frequency predominately by health care–related factors, which were associated with diabetes outcomes in type 1 diabetes.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc20-2983
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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  • 9
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    Risk Factors for the Development of Retinopathy in Prediabetes and Type 2 Diabetes: The Diabetes Prevention Program Experience
    American Diabetes Association ; 2022
    In:  Diabetes Care Vol. 45, No. 11 ( 2022-11-01), p. 2653-2661
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 45, No. 11 ( 2022-11-01), p. 2653-2661
    Abstract: To determine glycemic and nonglycemic risk factors that contribute to the presence of diabetic retinopathy (DR) before and after the onset of type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS During the Diabetes Prevention Program (DPP) and DPP Outcome Study (DPPOS), we performed fundus photography over time in adults at high risk for developing T2D, including after they developed diabetes. Fundus photographs were graded using the Early Treatment Diabetic Retinopathy Study (ETDRS) grading system, with DR defined as typical lesions of DR (microaneurysms, exudates, hemorrhage, or worse) in either eye. RESULTS By DPPOS year 16 (∼20 years after random assignment into DPP), 24% of 1,614 participants who had developed T2D and 14% of 885 who remained without diabetes had DR. In univariate analyses, using results from across the entire duration of follow-up, American Indian race was associated with less frequent DR compared with non-Hispanic White (NHW) race, and higher HbA1c, fasting and 2-h plasma glucose levels during an oral glucose tolerance test, weight, and history of hypertension, dyslipidemia, and smoking, but not treatment group assignment, were associated with more frequent DR. On multivariate analysis, American Indian race was associated with less DR compared with NHW (odds ratio [OR] 0.36, 95% CI 0.20–0.66), and average HbA1c was associated with more DR (OR 1.92, 95% CI 1.46–1.74 per SD [0.7%] increase in HbA1c). CONCLUSIONS DR may occur in adults with prediabetes and early in the course of T2D. HbA1c was an important risk factor for the development of DR across the entire glycemic range from prediabetes to T2D.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc22-0860
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2022
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  • 10
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    Effect of Metformin and Lifestyle Interventions on Mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study
    American Diabetes Association ; 2021
    In:  Diabetes Care Vol. 44, No. 12 ( 2021-12-01), p. 2775-2782
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 44, No. 12 ( 2021-12-01), p. 2775-2782
    Abstract: To determine whether metformin or lifestyle modification can lower rates of all-cause and cause-specific mortality in the Diabetes Prevention Program and Diabetes Prevention Program Outcomes Study. RESEARCH DESIGN AND METHODS From 1996 to 1999, 3,234 adults at high risk for type 2 diabetes were randomized to an intensive lifestyle intervention, masked metformin, or placebo. Placebo and lifestyle interventions stopped in 2001, and a modified lifestyle program was offered to everyone, but unmasked study metformin continued in those originally randomized. Causes of deaths through 31 December 2018 were adjudicated by blinded reviews. All-cause and cause-specific mortality hazard ratios (HRs) were estimated from Cox proportional hazards regression models and Fine-Gray models, respectively. RESULTS Over a median of 21 years (interquartile range 20–21), 453 participants died. Cancer was the leading cause of death (n = 170), followed by cardiovascular disease (n = 131). Compared with placebo, metformin did not influence mortality from all causes (HR 0.99 [95% CI 0.79, 1.25]), cancer (HR 1.04 [95% CI 0.72, 1.52] ), or cardiovascular disease (HR 1.08 [95% CI 0.70, 1.66]). Similarly, lifestyle modification did not impact all-cause (HR 1.02 [95% CI 0.81, 1.28] ), cancer (HR 1.07 [95% CI 0.74, 1.55]), or cardiovascular disease (HR 1.18 [95% CI 0.77, 1.81] ) mortality. Analyses adjusted for diabetes status and duration, BMI, cumulative glycemic exposure, and cardiovascular risks yielded results similar to those for all-cause mortality. CONCLUSIONS Cancer was the leading cause of mortality among adults at high risk for type 2 diabetes. Although metformin and lifestyle modification prevented diabetes, neither strategy reduced all-cause, cancer, or cardiovascular mortality rates.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc21-1046
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2021
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