Risk of hypoglycaemia in people aged ≥65 years receiving linagliptin: pooled data from 1489 individuals with type 2 diabetes mellitus

Nauck, Michael A.; Araki, Atsushi; Hehnke, Uwe; Plat, Arian W.; Clark, Douglas; Khunti, Kamlesh

doi:10.1111/ijcp.13240

Cited by 6 publications

(8 citation statements)

References 54 publications

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“…Previous studies investigating the safety and efficacy of linagliptin in older patients found that linagliptin provided effective glucose control in this population, without a significant increase in undesirable AEs . Importantly, linagliptin did not increase the risk of hypoglycaemia in older patients even when used in conjunction with therapies with a known risk of hypoglycaemia, such as insulin and sulphonylureas …”

Section: Discussionmentioning

confidence: 89%

“…19,21 Importantly, linagliptin did not increase the risk of hypoglycaemia in older patients even when used in conjunction with therapies with a known risk of hypoglycaemia, such as insulin and sulphonylureas. [19][20][21] We recognize limitations to this study. The lower age cut-off for study inclusion was reduced to 60 years through a protocol amendment, while guideline-based thresholds for "elderly" populations refer to either 65 or 70 years of age, respectively.…”

Section: Overall Safetymentioning

confidence: 92%

“…Despite the wealth of data available for DPP‐4 inhibitors in the general population with type 2 diabetes, there are sparse clinical trial data in older persons. In the case of linagliptin, pooled phase 3 data have shown a low risk of hypoglycaemia in older persons with type 2 diabetes, even when used in combination with therapies known to have a high risk of hypoglycaemia, such as insulins and sulphonylureas . Additionally, a dedicated clinical trial in older individuals with type 2 diabetes (aged ≥70 years)—over half of whom were also taking sulphonylureas or insulin—reported no significant difference in the incidence of hypoglycaemia with linagliptin compared with placebo .…”

Section: Introductionmentioning

confidence: 99%

“…In the case of linagliptin, pooled phase 3 data have shown a low risk of hypoglycaemia in older persons with type 2 diabetes, even when used in combination with therapies known to have a high risk of hypoglycaemia, such as insulins and sulphonylureas. 19,20 Additionally, a dedicated clinical trial in older individuals with type 2 diabetes (aged ≥70 years)-over half of whom were also taking sulphonylureas or insulin-reported no significant difference in the incidence of hypoglycaemia with linagliptin compared with placebo. 21 We report here novel results from a dedicated phase 4 randomized, clinical study that investigated the efficacy and safety of linagliptin as intensification therapy for glucose control in older individuals with type 2 diabetes on stable background treatment with basal insulin.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of linagliptin to improve glucose control in older people with type 2 diabetes on stable insulin therapy: A randomized trial

Ledesma¹,

Umpiérrez

Morley

et al. 2019

Diabetes Obesity Metabolism

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Aim To assess the addition of linagliptin as an alternative to insulin uptitration in older people with type 2 diabetes on stable insulin therapy. Materials and Methods This phase 4, randomized, multicentre, double‐blinded, placebo‐controlled, 24‐week study recruited individuals on stable insulin, with baseline HbA1c 7.0%‐10.0%, aged ≥60 years and body mass index ≤45 kg/m2. HbA1c and fasting plasma glucose were measured at study visits, and participants assessed glycaemic control with a self‐monitoring blood glucose device. Adverse events (AEs) were reported during the study. Results Three hundred and two participants were randomized 1:1 to linagliptin 5 mg qd and placebo, with one third of patients from Japan. Study population age and HbA1c (baseline mean ± SD) were 72.4 ± 5.4 years and 8.2 ± 0.8%, respectively; ~80% of participants were aged ≥70 years; 80% had macrovascular complications, one third had a baseline estimated glomerular filtration rate <60 mL/min/1.73 m2; and half had been diagnosed with diabetes for >15 years. Linagliptin significantly improved glucose control at 24 weeks (HbA1c‐adjusted mean change vs. placebo: –0.63%; P <0.0001) and the probability of achieving predefined HbA1c targets without hypoglycaemia (HbA1c <8.0%: OR 2.02; P <0.05 and HbA1c <7.0%: OR 2.44; P <0.01). Linagliptin versus placebo was well tolerated, with similar incidences of AEs, including clinically important hypoglycaemia (blood glucose <54 mg/dL) or severe hypoglycaemia. Conclusions Addition of linagliptin improves glucose control without an excess of hypoglycaemia in older patients with type 2 diabetes on stable insulin therapy.

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Section: Discussionmentioning

confidence: 89%

Section: Overall Safetymentioning

confidence: 92%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Efficacy and safety of linagliptin to improve glucose control in older people with type 2 diabetes on stable insulin therapy: A randomized trial

Ledesma¹,

Umpiérrez

Morley

et al. 2019

Diabetes Obesity Metabolism

View full text Add to dashboard Cite

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“…Linagliptin is a glucose-lowering drug with a good safety profile established across multiple clinical trials [11]. Meta-analyses that included data from participants aged ≥ 65 years have confirmed that the safety profile of linagliptin also extends to its use in the elderly population [28, 29]. In the current study conducted in Japanese older patients, linagliptin was well tolerated, and AEs occurred with similar rates in both the linagliptin and placebo groups.…”

Section: Discussionmentioning

confidence: 52%

Long-Term Efficacy and Safety of Linagliptin in a Japanese Population with Type 2 Diabetes Aged ≥ 60 Years Treated with Basal Insulin: A Randomised Trial

et al. 2019

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IntroductionAn estimated 4.3 million people aged ≥ 65 years with diabetes live in Japan. We evaluated the efficacy and safety of linagliptin in older Japanese patients with poorly controlled type 2 diabetes (T2DM).MethodsIn this phase 4, randomised, placebo-controlled national study (part of a global study) conducted in Japan over a period of 52 weeks, 102 patients on stable treatment with basal insulin ± metformin/alpha-glucosidase inhibitors were randomised (1:1) to receive linagliptin 5 mg qd or placebo. The primary end point was the change in glycated haemoglobin (HbA1c) after 24 weeks of treatment, with additional analyses at 52 weeks.ResultsMean age and HbA1c of the study population were 71 years and 8.1%, respectively. Approximately two-thirds of participants were aged ≥ 70 years, two-thirds had macrovascular complications, approximately half had a baseline estimated glomerular filtration rate < 60 ml/min/1.73 m2, and two-thirds had a time since diagnosis of diabetes > 10 years. Significant HbA1c reductions with linagliptin vs. placebo were observed at 24 weeks, – 0.71% (95% CI − 0.96, − 0.45, p < 0.0001), and maintained at 52 weeks, – 0.58% (95% CI − 0.82, − 0.34, p < 0.0001). Linagliptin improved the chances of achieving a categorical HbA1c target (< 8.0% and < 7.0%) at 24 and 52 weeks in patients who were not at their respective target at the beginning of the study. Addition of linagliptin to insulin was associated with a numerical increase in the risk of any hypoglycaemia, but not in the risk of clinically significant hypoglycaemia, severe hypoglycaemia or recurring hypoglycaemia.ConclusionLinagliptin was effective in improving glucose control in Japanese patients aged ≥ 60 years with T2DM on stable glucose-lowering therapy with basal insulin. Linagliptin was well tolerated and no new safety concerns were raised. The results presented here are highly consistent with the results from the global study, which was conducted over a 24-week period.Trial RegistrationClinicalTrials.gov identifier, NCT02240680.FundingBoehringer Ingelheim and Eli Lilly and Company Diabetes Alliance.Electronic Supplementary MaterialThe online version of this article (10.1007/s12325-019-01065-7) contains supplementary material, which is available to authorized users.

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Efficacy / safety balance of DPP-4 inhibitors versus SGLT2 inhibitors in elderly patients with type 2 diabetes

Scheen

2021

Diabetes & Metabolism

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Risk of hypoglycaemia in people aged ≥65 years receiving linagliptin: pooled data from 1489 individuals with type 2 diabetes mellitus

Cited by 6 publications

References 54 publications

Efficacy and safety of linagliptin to improve glucose control in older people with type 2 diabetes on stable insulin therapy: A randomized trial

Efficacy and safety of linagliptin to improve glucose control in older people with type 2 diabetes on stable insulin therapy: A randomized trial

Long-Term Efficacy and Safety of Linagliptin in a Japanese Population with Type 2 Diabetes Aged ≥ 60 Years Treated with Basal Insulin: A Randomised Trial

Efficacy / safety balance of DPP-4 inhibitors versus SGLT2 inhibitors in elderly patients with type 2 diabetes

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