Twenty Years of Insulin Gla-100: A Systematic Evaluation of Its Efficacy and Safety in Type 2 Diabetes Mellitus

Sethi, Bipin; Unnikrishnan, AG; Ayyar, Vageesh; Jabbar, P K; Ganguly, K K; Bhandari, Sudhir; Rastogi, Ashu; Mukherjee, Rajarshi; Sundaram, Vivek; Asirvatham, Adlyne Reena

doi:10.1007/s13300-022-01284-2

Cited by 2 publications

(2 citation statements)

References 88 publications

(367 reference statements)

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“…Consistent with the known safety and tolerability profile for GLP-1 RAs, 5,6,21,22 incidence of hypoglycaemia was low with efpeglenatide (and comparable with dulaglutide), except in AMPLITUDE-L, wherein participants, because of concomitant BI treatment, were expected to experience hypoglycaemia in general. 23,24 Additionally, in AMPLITUDE-L and AMPLITUDE-S, participants were receiving SUs in background ($44% and $ 51%, respectively), which is also known to cause hypoglycaemia, especially when combined with a GLP-1 RA. 19,25 Incidence of gastrointestinal AEs was higher in efpeglenatide treatment groups than with placebo, but comparable with dulaglutide.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of once‐weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE‐D, AMPLITUDE‐L and AMPLITUDE‐S randomized controlled trials

Aroda

Frías

et al. 2023

Diabetes Obesity Metabolism

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Aim: To evaluate the efficacy and safety of once-weekly (QW) efpeglenatide in people with type 2 diabetes (T2D) suboptimally controlled with oral glucose-lowering drugs and/or basal insulin (BI).Materials and Methods: Three phase 3, multicentre, randomized controlled trials compared the efficacy and safety of QW efpeglenatide versus dulaglutide when added to metformin (AMPLITUDE-D), efpeglenatide versus placebo when added to BI ± oral glucose-lowering drugs (AMPLITUDE-L) or metformin ± sulphonylurea (AMPLITUDE-S). All trials were terminated early by the sponsor because of funding rather than safety or efficacy concerns.Results: In AMPLITUDE-D, non-inferiority of efpeglenatide to dulaglutide 1.5 mg was shown in HbA1c reduction from baseline to week 56, least squares mean treatment difference (95% CI): 4 mg, À0.03% (À0.20%, 0.14%)/À0.35 mmol/mol (À2.20, 1.49); 6 mg, À0.08% (À0.25%, 0.09%)/À0.90 mmol/mol (À2.76, 0.96). The reductions in body weight (approximately 3 kg) from baseline to week 56 were similar across all treatment groups. In AMPLITUDE-L and AMPLITUDE-S, numerically greater reduction in HbA1c and body weight were observed at all doses of efpeglenatide than placebo. American Diabetes Association level 2 hypoglycaemia (< 54 mg/ dL [< 3.0 mmol/L]) was reported in few participants across all treatment groups (AMPLITUDE-D, ≤ 1%; AMPLITUDE-L, ≤ 10%; and AMPLITUDE-S, ≤ 4%). The adverse events profile was consistent with other glucagon-like peptide-1 receptor agonists (GLP-1 RAs); gastrointestinal adverse events were most frequent in all three studies. Conclusions:In people with T2D suboptimally controlled with oral glucose-lowering drugs and/or BI, QW efpeglenatide was non-inferior to dulaglutide in terms of HbA1c reduction and showed numerically greater improvements than placebo in glycaemic control and body weight, with safety consistent with the GLP-1 RA class.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of once‐weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE‐D, AMPLITUDE‐L and AMPLITUDE‐S randomized controlled trials

Aroda

Frías

et al. 2023

Diabetes Obesity Metabolism

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“…Авторы систематического обзора подчеркнули эффективность и безопасность Глар-100 по сравнению с другими препаратами инсулина при инициации и интенсификации терапии СД2 [46].…”

Section: эндокринологияunclassified

Glycemic control and cardiovascular complications of type 2 diabetes mellitus

Druk,

Safronova

2023

Medicinskij sovet

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Over the past few decades, the prevalence of diabetes in developed and developing countries has increased dramatically, making diabetes a key health priority worldwide. It can be assumed that an increase in the life expectancy of patients with diabetes significantly affects the prevalence of diabetes, maintaining the trend of its increase. Patients with type 2 diabetes mellitus (DM2) are at higher risk for cardiovascular disease and its adverse outcomes compared to the general population. The pathophysiological relationship between hyperglycemia and cardiovascular disease is beyond doubt. Glycemic control per se remains essential for the successful management of diabetes, prevention of chronic complications of the disease and death. Diabetes control involves, first of all, the achievement of target indicators of carbohydrate metabolism. The use of glycated hemoglobin (HbA1c), despite known sensitivity limitations, has become the standard for assessing glycemic control in diabetic patients. Early achievement of the target HbA1c level reduces the risk of diabetic complications, increases the likelihood of long-term sustainable disease control. Numerous clinical studies have demonstrated that higher HbA1c and greater HbA1c variability are manageable risk factors for adverse cardiovascular events. Optimal hypoglycemic therapy for diabetes in order to reduce cardiovascular risks should ensure the achievement of the target level of glycemic control as soon as possible (the first 3 months of therapy), maintaining the target level of glycemia with the lowest possible HbA1c variability in subsequent years and therapy should be safe. Timely intensification of therapy, including the use of insulin, can prevent the negative consequences of prolonged hyperglycemia. Glar-100 has a high efficacy and safety in comparison with other insulin preparations at the initiation and intensification of DM2 therapy. RingGlar® and Lantus® are equivalent drugs.

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Twenty Years of Insulin Gla-100: A Systematic Evaluation of Its Efficacy and Safety in Type 2 Diabetes Mellitus

Cited by 2 publications

References 88 publications

Efficacy and safety of once‐weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE‐D, AMPLITUDE‐L and AMPLITUDE‐S randomized controlled trials

Efficacy and safety of once‐weekly efpeglenatide in people with suboptimally controlled type 2 diabetes: The AMPLITUDE‐D, AMPLITUDE‐L and AMPLITUDE‐S randomized controlled trials

Glycemic control and cardiovascular complications of type 2 diabetes mellitus

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