Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes

Inzucchi, Silvio E.; Bergenstal, Richard M.; Buse, John B.; Diamant, Michaëla; Ferrannini, Ele; Nauck, Michael A.; Peters, Anne L.; Τσάπας, Απόστολος; Wender, Richard C.; Matthews, David R.

doi:10.1007/s00125-014-3460-0

Cited by 654 publications

(722 citation statements)

References 62 publications

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“…Position statements from the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) recommend a patient‐centred approach with individualized glycaemic targets to minimize hypoglycaemia 4, 5.…”

Section: Introductionmentioning

confidence: 99%

Regional variations in definitions and rates of hypoglycaemia: findings from the global HAT observational study of 27 585 people with Type 1 and insulin‐treated Type 2 diabetes mellitus

et al. 2018

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AimTo determine participant knowledge and reporting of hypoglycaemia in the non‐interventional Hypoglycaemia Assessment Tool (HAT) study.Methods HAT was conducted in 24 countries over a 6‐month retrospective/4‐week prospective period in 27 585 adults with Type 1 or insulin‐treated Type 2 diabetes mellitus. Participants recorded whether hypoglycaemia was based on blood glucose levels, symptoms or both.ResultsHypoglycaemia rates were consistently higher in the prospective compared with the retrospective period. Most respondents (96.8% Type 1 diabetes; 85.6% Type 2 diabetes) knew the American Diabetes Association/European Association for the Study of Diabetes hypoglycaemia definition, but there were regional differences in the use of blood glucose measurements and/or symptoms to define events. Confirmed symptomatic hypoglycaemia rates were highest in Northern Europe/Canada for Type 1 diabetes (63.9 events/year) and in Eastern Europe for Type 2 diabetes (19.4 events/year), and lowest in South East Asia (Type 1 diabetes: 6.0 events/year; Type 2 diabetes: 3.2 events/year). Unconfirmed symptomatic hypoglycaemia rates were highest in Eastern Europe for Type 1 diabetes (5.6 events/year) and South East Asia for Type 2 diabetes (4.7 events/year), and lowest for both in Russia (Type 1 diabetes: 2.1 events/year; Type 2 diabetes: 0.4 events/year). Participants in Latin America reported the highest rates of severe hypoglycaemia (Type 1 diabetes: 10.8 events/year; Type 2 diabetes 3.7 events/year) and severe hypoglycaemia requiring hospitalization (Type 1 diabetes: 0.56 events/year; Type 2 diabetes: 0.44 events/year). The lowest rates of severe hypoglycaemia were reported in South East Asia (Type 1 diabetes: 2.0 events/year) and Northern Europe/Canada (Type 2 diabetes: 1.3 events/year), and the lowest rates of severe hypoglycaemia requiring hospitalization were in Russia (Type 1 diabetes: 0.15 events/year; Type 2 diabetes: 0.09 events/year). The blood glucose cut‐off used to define hypoglycaemia varied between regions (Type 1 diabetes: 3.1–3.6 mmol/l; Type 2 diabetes: 3.5–3.8 mmol/l).ConclusionsUnder‐reporting of hypoglycaemia rates in retrospective recall and regional variations in participant definitions of hypoglycaemia may contribute to the global differences in reported rates. Discrepancies between participant definitions and guidelines may highlight a need to redefine hypoglycaemia criteria. (Clinical Trials Registry No: NCT01696266).

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Section: Introductionmentioning

confidence: 99%

Regional variations in definitions and rates of hypoglycaemia: findings from the global HAT observational study of 27 585 people with Type 1 and insulin‐treated Type 2 diabetes mellitus

et al. 2018

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“…Treatment of type 2 diabetes mellitus focuses on lowering blood glucose levels through exercise, diet, and medication if exercise and diet alone do not result in adequate improvement; the goal of type 2 diabetes mellitus therapy is prevention of microvascular complications and management of atherosclerotic cardiovascular disease with a patient‐centered approach5, 6. The JDS recommends HbA1c target levels below 7% for glycemic control to prevent complications in patients with type 2 diabetes mellitus7.…”

Section: Introductionmentioning

confidence: 99%

Safety, tolerability and efficacy of lixisenatide as monotherapy in Japanese patients with type 2 diabetes mellitus: An open‐label, multicenter study

Seino

Terauchi

Wang

et al. 2017

J of Diabetes Invest

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Aim/IntroductionTo assess the overall safety of lixisenatide monotherapy in Japanese patients with type 2 diabetes mellitus.Materials and MethodsPatients with type 2 diabetes mellitus, previously treated with ≤1 oral antidiabetic drug, were enrolled in an uncontrolled, open‐label, single‐arm study over 24 and 52 weeks. Any oral antidiabetic drug treatment was stopped at the start of the 6‐week run‐in period. From baseline, patients received once‐daily lixisenatide monotherapy (10 μg for 1 week, 15 μg for 1 week, 20 μg thereafter) for 52 weeks (first 140 patients enrolled) or 24 weeks (subsequently enrolled patients). The primary end‐point was safety over 24 and 52 weeks. Secondary efficacy end‐points included absolute change in glycated hemoglobin, fasting plasma glucose and bodyweight from baseline.ResultsOf 428 patients screened, 361 and 140 were treated for 24 and 52 weeks, respectively; 88.4 and 90.0% completed treatment. During the 24‐ and 52‐week treatment periods, 268/361 (74.2%) and 117/140 (83.6%) patients, respectively, had treatment‐emergent adverse events; the most frequently reported was nausea (33.2 and 31.4%, respectively). The risk of severe hypoglycemia was low; only one case was reported. Lixisenatide treatment resulted in a decrease in mean glycated hemoglobin A1c (−0.98 and −0.86%), fasting plasma glucose (−1.05 and −0.85 mmol/L), and bodyweight (−1.33 and −1.48 kg) for the 24‐ and 52‐week treatment periods, respectively.ConclusionsOnce‐daily lixisenatide monotherapy was associated with a safety profile in line with the glucagon‐like peptide‐1 receptor agonist class, and improved glycemic control in Japanese patients with type 2 diabetes mellitus.

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“…The most common AEs leading to discontinuation of semaglutide were GI in nature and, overall, most cases of GI AEs were mild or moderate and of a short duration 12, 13, 14, 15, 16, 23, 24. GI AEs are commonly observed across the GLP‐1RA class,2, 9 and may affect treatment outcomes in the real‐world setting. In SUSTAIN 1 to 5, >80% of participants experienced no GI AEs, regardless of their randomized treatment; however, the proportion of participants with no GI AEs was lower with semaglutide, vs comparators, except in the semaglutide 0.5 mg group in SUSTAIN 5.…”

Section: Discussionmentioning

confidence: 99%

“…Initial management of T2D involves lifestyle changes and monotherapy with metformin 1, 2. Often, however, as glycaemic control deteriorates, combination therapy with other oral antidiabetic drugs (OADs) is required, with or without injectable therapies such as insulin and glucagon‐like peptide‐1 receptor agonists (GLP‐1RAs) 1, 2…”

Section: Introductionmentioning

confidence: 99%

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Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme

DeVries

Desouza

Bellary

et al. 2018

Diabetes Obesity Metabolism

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AimTo evaluate the potential for semaglutide to help people with type 2 diabetes (T2D) achieve glycated haemoglobin (HbA1c) targets while avoiding unwanted outcomes, such as weight gain, hypoglycaemia and gastrointestinal (GI) side effects.Materials and methodsData from the phase IIIa SUSTAIN 1 to 5 clinical trials were analysed. Participants had inadequately controlled T2D and were drug‐naïve (SUSTAIN 1) or on a range of background treatments (SUSTAIN 2 to 5). The main protocol‐specified composite endpoint was the proportion of participants achieving HbA1c <53 mmol/mol (7.0%) at end of treatment (30 or 56 weeks) without weight gain and with no severe or blood glucose (BG)‐confirmed symptomatic hypoglycaemia. A post hoc composite endpoint was the proportion of participants achieving the primary composite endpoint without moderate or severe GI adverse events (AEs).ResultsAcross the SUSTAIN trials 1 to 5, 3918 participants with T2D were randomized to once‐weekly subcutaneous semaglutide 0.5 mg, 1.0 mg, or comparators (placebo, sitagliptin 100 mg, exenatide extended release 2.0 mg or insulin glargine). The proportion of participants achieving HbA1c <53 mmol/mol (7.0%) with no weight gain and no severe/BG‐confirmed symptomatic hypoglycaemia was 47% to 66% (semaglutide 0.5 mg) and 57% to 74% (semaglutide 1.0 mg) vs 7% to 19% (placebo) and 16% to 29% (active comparators; all P < .0001). More participants achieved the primary composite endpoint with no moderate or severe GI AEs with semaglutide vs comparators (all P < .0001).ConclusionSemaglutide helped more people with T2D achieve HbA1c targets than did comparators in the SUSTAIN 1 to 5 trials, while avoiding unwanted outcomes such as weight gain, hypoglycaemia and GI side effects.

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Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes

Cited by 654 publications

References 62 publications

Regional variations in definitions and rates of hypoglycaemia: findings from the global HAT observational study of 27 585 people with Type 1 and insulin‐treated Type 2 diabetes mellitus

Regional variations in definitions and rates of hypoglycaemia: findings from the global HAT observational study of 27 585 people with Type 1 and insulin‐treated Type 2 diabetes mellitus

Safety, tolerability and efficacy of lixisenatide as monotherapy in Japanese patients with type 2 diabetes mellitus: An open‐label, multicenter study

Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme

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