Reduced risk of hypoglycemia with once-daily glargine versus twice-daily NPH and number needed to harm with NPH to demonstrate the risk of one additional hypoglycemic event in type 2 diabetes: Evidence from a long-term controlled trial

Rosenstock, Julio; Fonseca, Vivian; Schinzel, S.; Dain, Marie-Paule; Mullins, Peter R.; Riddle, Matthew C.

doi:10.1016/j.jdiacomp.2014.04.003

Cited by 37 publications

(28 citation statements)

References 34 publications

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“…It has been demonstrated that the burden of hypoglycaemia, as assessed by event rate and incidence, increases as insulin is titrated to achieve HbA1c ranges consistent with commonly recommended treatment targets . The present study evaluated event rates and incidences of hypoglycaemia and hypothesized that they might be lower in the group continuing sitagliptin compared with the group discontinuing sitagliptin.…”

Section: Discussionmentioning

confidence: 89%

“…DPP‐4 inhibitors, which improve postprandial glycaemic control by stabilizing the endogenous incretin peptides glucagon‐like peptide‐1 (GLP‐1) and glucose‐dependent insulinotropic peptide (GIP), directly address this pathophysiology. In addition, it has been shown that event rates of hypoglycaemia increase as basal insulin is progressively titrated to achieve glycated haemoglobin (HbA1c) targets consistent with scientific society guidance, which probably plays a role in the inability to achieve glycaemic goals in many patients. Continuation of DPP‐4 inhibitors might result in reduced rates of hypoglycaemia at lower HbA1c targets because of a reduced requirement for insulin and/or because of the glucagonotropic effects of GIP during hypoglycaemia …”

Section: Introductionmentioning

confidence: 99%

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Double‐blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase‐4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT‐I Study

Roussel

Durán-García

Zhang

et al. 2018

Diabetes Obesity Metabolism

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Aims To compare the effects of continuing versus discontinuing sitagliptin when initiating and intensively titrating insulin glargine. Materials and methods Eligible patients had inadequately controlled type 2 diabetes on metformin (≥1500 mg/d) in combination with a dipeptidyl peptidase‐4 (DPP‐4) inhibitor and/or a sulphonylurea. Those on metformin + sitagliptin were directly randomized; all others were switched to metformin + sitagliptin (discontinuing other DPP‐4 inhibitors and sulphonylureas) and stabilized during a run‐in period. At randomization, patients were allocated to continuing sitagliptin or discontinuing sitagliptin, with both groups initiating insulin glargine and titrating to a target fasting glucose of 4.0 to 5.6 mmol/L. Results A total of 743 participants (mean glycated haemoglobin [HbA1c] 72.6 mmol/mol [8.8%], disease duration 10.8 years), were treated. After 30 weeks, the mean HbA1c and least squares (LS) mean change from baseline in HbA1c were 51.4 mmol/mol (6.85%) and −20.5 mmol/mol (−1.88%) in the sitagliptin group and 56.4 mmol/mol (7.31%) and −15.5 mmol/mol (−1.42%) in the placebo group; the difference in LS mean changes from baseline HbA1c was −5.0 mmol/mol (−0.46%; P < 0.001). The percentage of participants with HbA1c <53 mmol/mol (<7.0%) was higher (54% vs. 35%) and the mean daily insulin dose was lower (53 vs. 61 units) in the sitagliptin group. Despite lower HbA1c, event rates and incidences of hypoglycaemia were not higher in the sitagliptin group. Adverse events overall and changes from baseline in body weight were similar between the two treatment groups. Conclusion When initiating insulin glargine therapy, continuation of sitagliptin, compared with discontinuation, resulted in a clinically meaningful greater reduction in HbA1c without an increase in hypoglycaemia. http://ClinicalTrials.gov Identifier: NCT02738879.

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Section: Discussionmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Double‐blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase‐4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT‐I Study

Roussel

Durán-García

Zhang

et al. 2018

Diabetes Obesity Metabolism

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“…1). Data also show that basal insulin analogues have a lower risk of hypoglycaemia vs NPH insulin at all levels of HbA 1c [16,20].…”

Section: Insulin Initiationmentioning

confidence: 85%

“…(b) Insulin glargine vs NPH in combination with OAD therapy in patients with Type 2 diabetes in a 5‐year study. Prandial insulin could be added at the investigator's discretion . (Adapted from Rosenstock et al J Diabetes Complications , with permission from the American Diabetes Association.…”

Section: Insulin Initiationmentioning

confidence: 99%

Role of incretin‐based therapies and sodium‐glucose co‐transporter‐2 inhibitors as adjuncts to insulin therapy in Type 2 diabetes, with special reference to IDegLira

Wilding

Bain

2015

Diabet. Med.

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The progressive nature of Type 2 diabetes necessitates treatment intensification over time in order to maintain glycaemic control, with many patients ultimately requiring insulin therapy. While insulin has unlimited potential efficacy, its initiation is often delayed and improvements in glycaemic control are typically accompanied by weight gain and an increased risk of hypoglycaemia, particularly as HbA1c approaches and falls below target levels. This may account for the sub-optimal control often achieved after insulin initiation. Combining insulin with antihyperglycaemic therapies that have a low risk of hypoglycaemia and are weight-neutral or result in weight loss is a therapeutic strategy with the potential to improve Type 2 diabetes management. Although the effects differ with each individual class of therapy, clinical trials have shown that adding a glucagon-like peptide-1 receptor agonist, dipeptidyl peptidase-4 inhibitor or sodium-glucose co-transporter-2 inhibitor to insulin regimens can offer a significant reduction in HbA1c without substantially increasing hypoglycaemia risk, or weight. The evidence and merit of each approach are reviewed in this paper. Once-daily co-formulations of a basal insulin and a glucagon-like peptide-1 receptor agonist have been developed (insulin degludec/liraglutide) or are under development (lixisenatide/insulin glargine). Insulin degludec/liraglutide phase III trials and a lixisenatide/insulin glargine phase II trial have shown robust HbA1c reductions, with weight loss and a low risk of hypoglycaemia. With insulin degludec/liraglutide now approved in Europe, an important consideration will be the types of patients who may benefit most from a fixed-ratio combination; this is discussed in the present review, and we also take a look toward future developments in the field.

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“…The number needed to harm by choosing NPH over glargine was 25 in terms of causing hypoglycemia (Rosenstock, Fonseca, Schinzel, et al, 2014).…”

Section: 3mentioning

confidence: 99%

Benefits of timely basal insulin control in patients with type 2 diabetes

Lovre

Fonseca

2015

Journal of Diabetes and its Complications

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Worldwide, both underdiagnosis and undertreatment leave many patients exposed to long periods of hyperglycemia and contribute to irreversible diabetes complications. Early glucose control reduces the risk of both macrovascular and microvascular complications, while tight control late in diabetes has little or no macrovascular benefit. Insulin therapy offers the most potent antihyperglycemic effect of all diabetes agents, and has a unique ability to induce diabetes remission when used to normalize glycemia in newly diagnosed patients. When used as a second-line therapy, basal insulin is more likely to safely and durably maintain A1C levels ≤7% than when insulin treatment is delayed. The use of basal insulin analogs is associated with a reduced risk of hypoglycemia and weight gain compared to NPH insulin and pre-mixed insulin. Patient self-titration algorithms can improve glucose control while decreasing the burden on office staff. Finally, recent data suggest that addition of incretin agents to basal insulin may improve glycemic control with very little, if any increased risk of hypoglycemia or weight gain.

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Reduced risk of hypoglycemia with once-daily glargine versus twice-daily NPH and number needed to harm with NPH to demonstrate the risk of one additional hypoglycemic event in type 2 diabetes: Evidence from a long-term controlled trial

Cited by 37 publications

References 34 publications

Double‐blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase‐4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT‐I Study

Double‐blind, randomized clinical trial comparing the efficacy and safety of continuing or discontinuing the dipeptidyl peptidase‐4 inhibitor sitagliptin when initiating insulin glargine therapy in patients with type 2 diabetes: The CompoSIT‐I Study

Role of incretin‐based therapies and sodium‐glucose co‐transporter‐2 inhibitors as adjuncts to insulin therapy in Type 2 diabetes, with special reference to IDegLira

Benefits of timely basal insulin control in patients with type 2 diabetes

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