Incidence, characteristics and impact of hypoglycaemia in patients receiving intensified treatment for inadequately controlled type 2 diabetes mellitus

Tschöpe, D; Bramlage, Peter; Schneider, Steffen; Gitt, Anselm K.

doi:10.1177/1479164115610470

Cited by 10 publications

(6 citation statements)

References 43 publications

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“…The relationship between GV and hypoglycemia has been elucidated in a number of studies, with hypoglycemia being more common in patients with increased GV. 8, 9 In a pooled analysis of 6 randomized controlled trials of 1,699 adult patients with T2D who received 24 weeks of insulin glargine or comparators, all measures of GV were significantly associated with poor glycemic control (A1C ≥ 7.0%) and on-trial development of hypoglycemia. 10 In addition, a reduction in GV correlated strongly with reductions in both hypoglycemia and hyperglycemia episodes.…”

Section: Effects Of Gv On Patientsmentioning

confidence: 99%

“…Patients should be evaluated for treatment on a case-by-case basis, ensuring that the selection of diabetes medication and blood glucose targets are likely to benefit the individual, while also reducing the risks of hypoglycemia. 9 Emerging research suggests that the addition of an incretin mimetic with prominent PPG-lowering effects to basal insulin (such as a GLP- 1 RA) 69 could help patients achieve optimal glycemic control while minimizing the potential for hypoglycemia.…”

Section: Significance Of Gv In Clinical Practicementioning

confidence: 99%

See 1 more Smart Citation

Glycemic Variability: How to Measure and Its Clinical Implication for Type 2 Diabetes

Umpiérrez

Kovatchev

2018

The American Journal of the Medical Sciences

116

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Glycated hemoglobin A1c (A1C) levels have traditionally been the gold standard for assessing glycemic control and treatment efficacy in patients with type 2 diabetes. However, A1C does not take into account fluctuations in blood glucose levels known as glycemic variability (GV). In recent years, GV has become increasingly clinically relevant, because of a better understanding of the need to reach target A1C while avoiding hypoglycemia. GV relates to both hyperglycemia and hypoglycemia, and has been associated with poorer quality of life. Diabetes treatments targeting multiple pathophysiological mechanisms are most beneficial in controlling A1C and reducing GV. In clinical trials, a number of metrics are used to measure GV, many of which are not well understood in the clinical practice. Until a gold standard metric for GV is established, the variety of measurements available may confound the choice of an optimal treatment for an individual patient.

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Section: Effects Of Gv On Patientsmentioning

confidence: 99%

Section: Significance Of Gv In Clinical Practicementioning

confidence: 99%

Glycemic Variability: How to Measure and Its Clinical Implication for Type 2 Diabetes

Umpiérrez

Kovatchev

2018

The American Journal of the Medical Sciences

116

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“…However, higher glycaemic variability was not associated with MACE after adjusting for baseline and/or time varying risk factors, such as HbA 1c . DEVOTE 2 is the largest study to assess relationships between glucose variability and MACE/mortality in communityliving individuals with type 2 diabetes, and it is the largest study to relate fasting blood glucose variability with risk for severe hypoglycaemia [8][9][10][11]. However, it has some limitations: first, this was a post hoc analysis of trial data obtained for another purpose.…”

Section: Devotementioning

confidence: 99%

Devoting attention to glucose variability and hypoglycaemia in type 2 diabetes

Rutter

2017

Diabetologia

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In the Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE), insulin degludec was non-inferior to insulin glargine in terms of cardiovascular events and mortality. However, there were lower rates of severe hypoglycaemia with insulin degludec. DEVOTE investigators now extend these findings by presenting the results of two observational epidemiological analyses based on trial data. In the first of these analyses (DEVOTE 2), Zinman et al (Diabetologia DOI: 10.1007/s00125-017-4423-z ) demonstrate that, compared with individuals with lower day-to-day fasting glycaemic variability, those with higher day-to-day fasting glycaemic variability had a similar risk of major adverse cardiovascular events (MACE) but a higher risk of severe hypoglycaemia and all-cause mortality. In the second analysis (DEVOTE 3), Pieber et al (Diabetologia DOI: 10.1007/s00125-017-4422-0 ) found that individuals who experienced severe hypoglycaemia had a similar risk of MACE compared with those who never experienced severe hypoglycaemia, but had a more than twofold higher risk of subsequent total mortality and cardiovascular disease (CVD) mortality. The strengths of these studies relate to the availability of high-quality prospective data on adjudicated severe hypoglycaemia, MACE and mortality events in a large number of high-risk insulin-treated individuals with type 2 diabetes. Limitations include the observational nature of the data and thus residual confounding remains possible. Furthermore, the short duration of the trial resulted in limited statistical power for some analyses. Therefore, whilst DEVOTE 2 and DEVOTE 3 raise awareness of the mortality risks associated with glucose variability and severe hypoglycaemia in high-risk, insulin-treated patients with type 2 diabetes, they cannot clarify causal relationships. Preventing severe hypoglycaemia in those with type 2 diabetes should already be a priority in clinical practice. However, findings from future clinical trials are needed to guide physicians on whether it is beneficial to target glucose variability, and risk for severe hypoglycaemia, to reduce the risks for CVD events and mortality in these individuals.

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“…Importantly, the enhanced insulin release and inhibition of glucagon release responses facilitated by Lixi are glucose‐regulated, and in combination with reducing the rate of gastric emptying, lower the risk of hypoglycaemia 34,35 . This complementary action has been suggested to have a beneficial effect on glycaemic variability in individuals with T2D receiving iGlarLixi compared with iGlar or Lixi alone, 36 the occurrence of which has been associated with increased hypoglycaemia risk 37‐39 . In contrast, premixed BIAsp 30 provides a mixture of prandial and protaminated intermediate‐acting insulin 40,41 .…”

Section: Discussionmentioning

confidence: 99%

Hypoglycaemia events with iGlarLixi versus premix biphasic insulin aspart 30 (BIAsp 30) in people with type 2 diabetes advancing from basal insulin: An analysis of the SoliMix trial

McCrimmon

Home

Cheng

et al. 2022

Diabetes Obesity Metabolism

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Aims: To explore details of the incidence and rates of daytime and nocturnal hypoglycaemia, levels of hypoglycaemia, and relationship to glycated haemoglobin (HbA1c), when comparing iGlarLixi versus premixed biphasic insulin aspart 30 (BIAsp 30) in the SoliMix randomized controlled trial.Materials and Methods: This exploratory analysis of SoliMix used logistic regression and negative binomial regression analyses to assess between-treatment differences in the incidence and rates of hypoglycaemia by time of day. A negative binomial model was used to derive estimated annualized hypoglycaemia rates as a function of HbA1c.Results: iGlarLixi was associated with lower incidence and rates of American Diabetes Association Level 2 (<54 mg/dL [<3.0 mmol/L]) hypoglycaemia during both night and day versus BIAsp 30. Incidence and rates of Level 1 (<70 to ≥54 mg/dL [<3.9 to ≥3.0 mmol/L]) hypoglycaemia were also mostly shown to be reduced with iGlarLixi versus BIAsp 30. Severe (Level 3) events were too few for analysis (n = 3). iGlarLixi was associated with lower modelled event rates of Level 2 and Level 1 hypoglycaemia over a wide range of HbA1c levels versus BIAsp 30.Conclusions: These results show that the lower HbA1c levels and weight benefit seen with iGlarLixi versus premixed BIAsp 30 in people with type 2 diabetes advancing their basal insulin therapy in the SoliMix trial are also accompanied by a lower risk of hypoglycaemia at any time of day and across a broad range of HbA1c levels.

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Incidence, characteristics and impact of hypoglycaemia in patients receiving intensified treatment for inadequately controlled type 2 diabetes mellitus

Cited by 10 publications

References 43 publications

Glycemic Variability: How to Measure and Its Clinical Implication for Type 2 Diabetes

Glycemic Variability: How to Measure and Its Clinical Implication for Type 2 Diabetes

Devoting attention to glucose variability and hypoglycaemia in type 2 diabetes

Hypoglycaemia events with iGlarLixi versus premix biphasic insulin aspart 30 (BIAsp 30) in people with type 2 diabetes advancing from basal insulin: An analysis of the SoliMix trial

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