A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial

Umpiérrez, Guillermo E.; Cardona, Saumeth; Chachkhiani, David; Fayfman, Maya; Saiyed, Sahebi; Wang, Heqiong; Vellanki, Priyathama; Haw, J. Sonya; Olson, Darin E.; Pasquel, Francisco J.; Johnson, Theodore M.

doi:10.1016/j.jamda.2017.11.002

Cited by 34 publications

(38 citation statements)

References 39 publications

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“…Linagliptin has previously shown glucose-lowering efficacy and safety in multiple clinical trials. 9,29,36 From a pharmacological perspective, linagliptin is the only DPP-4 inhibitor excreted primarily via the bile, rather than the kidney, with kidney excretion accounting for only 5% of the dose. Therefore, no dose adjustment is required in patients with reduced kidney function, even at severe stages.…”

Section: Overall Safetymentioning

confidence: 99%

“…Notable deleterious effects caused by hypoglycaemia are cardiac arrhythmias, and altered mental status and cognition, which can, in turn, lead to falls and fractures . Furthermore, hospitalization as a result of hypoglycaemia in older people is associated with a substantial increase in morbidity and mortality . Consequently, guidelines for older adults emphasize minimizing the risk of hypoglycaemia …”

Section: Introductionmentioning

confidence: 99%

“…7,8 Furthermore, hospitalization as a result of hypoglycaemia in older people is associated with a substantial increase in morbidity and mortality. 9 Consequently, guidelines for older adults emphasize minimizing the risk of hypoglycaemia. 3,[10][11][12] As type 2 diabetes progresses and pancreatic β-cell function declines, many people require insulin therapy to achieve and maintain glycaemic control.…”

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: Overall Safetymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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“…Linagliptin, an orally active small‐molecule inhibitor of DPP‐4, licensed in the USA in 2011, has been shown to improve glycaemic control in adults with T2D . It is not necessary to modify the dose of linagliptin based on renal function; therefore, it is an ideal agent for use in the setting of hospitals and long‐term care facilities . We hypothesized that use of linagliptin, with correction doses of rapid‐acting supplemental insulin, would result in non‐inferior glycaemic control as compared with a basal‐bolus insulin regimen in non‐cardiac surgical patients with T2D.…”

Section: Introductionmentioning

confidence: 99%

Glycaemic efficacy and safety of linagliptin compared to a basal‐bolus insulin regimen in patients with type 2 diabetes undergoing non‐cardiac surgery: A multicentre randomized clinical trial

Vellanki

Rasouli

Baldwin

et al. 2018

Diabetes Obesity Metabolism

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Aims: The use of incretin-based therapy, rather than or complementary to, insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined the glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in hospitalized surgical patients with T2D. Materials and Methods:This prospective open-label multicentre study randomized T2D patients undergoing non-cardiac surgery with admission blood glucose (BG) of 7.8 to 22.2 mmol/L who were under treatment with diet, oral agents or total insulin dose (TDD) ≤ 0.5 units/kg/day to either linagliptin (n = 128) daily or basal-bolus (n = 122) with glargine once daily and rapid-acting insulin before meals. Both groups received supplemental insulin for BG > 7.8 mmol/L. The primary endpoint was difference in mean daily BG between groups.Results: Mean daily BG was higher in the linagliptin group compared to the basal-bolus group (9.5 AE 2.6 vs 8.8 AE 2.3 mmol/L/dL, P = 0.03) with a mean daily BG difference of 0.6 mmol/L (95% confidence interval 0.04, 1.2). In patients with randomization BG < 11.1 mmol/L (63% of cohort), mean daily BG was similar in the linagliptin and basal-bolus groups (8.9 AE 2.3 vs 8.7 AE 2.3 mmol/L, P = 0.43); however, patients with BG ≥ 11.1 mmol/L who were treated with linagliptin had higher BG compared to the basal-bolus group (10.9 AE 2.6 vs 9.2 AE 2.2 mmol/L, P < 0.001). Linagliptin resulted in fewer hypoglycaemic events (1.6% vs 11%, P = 0.001; 86% relative risk reduction), with similar supplemental insulin and fewer daily insulin injections (2.0 AE 3.3 vs 3.1 AE 3.3, P < 0.001) compared to the basal-bolus group.Conclusions: For patients with T2D undergoing non-cardiac surgery who presented with mild to moderate hyperglycaemia (BG < 11.1 mmol/L), daily linagliptin is a safe and effective alternative to multi-dose insulin therapy, resulting in similar glucose control with lower hypoglycaemia.The association between hyperglycaemia and poor clinical outcomes in patients with and without diabetes is well established. 1-5 Extensive data from observational and prospective randomized controlled trials in hospitalized patients have resulted in a strong association between hyperglycaemia and poor clinical outcomes, such as increased mortality, morbidity, length of hospital stay (LOS), infections and overall complications. 1,4,6-8 Most clinical trials in critically ill and in noncritically ill medicine and surgery patients with hyperglycaemia and diabetes have reported that improved glycaemic control reduces LOS, risk of multi-organ failure and systemic infections, 9-12 as well as short-and long-term mortality, 6,11 although the largest trial in critically ill patients showed increased mortality with intensive glucose control. 12 Current clinical guidelines from professional societies recommend basal-bolus insulin regimens as the standard of care for hospitalized patients with type 2 diabetes (T2D). 13,14 Our group has shown that a basal-bolus insulin regimen resulted in improved glycaemic co...

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“…In fact, the present study showed DPP‐4i was used in 67.6% of residents among those using any antidiabetic medicines in Japanese nursing homes, whereas its use is rare in other countries . A recent randomized controlled study showed that treatment with linagliptin, a DPP‐4i, resulted in a significantly lower risk of hypoglycemia and non‐inferior glycemic control compared with insulin glargine in nursing facilities in the USA …”

Section: Discussionmentioning

confidence: 67%

Low hemoglobin A1c and low body mass index are associated with dementia and activities of daily living disability among Japanese nursing home residents with diabetes

Hatano

Araki

Ishibashi

2019

Geriatrics Gerontology Int

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Aim: To investigate associations between glycemic control and dementia, activities of daily living (ADL), falls and fractures in Japanese older adults with type 2 diabetes mellitus living in nursing homes.Methods: A total of 384 older residents with diabetes aged ≥65 years from 95 out of 132 facilities in Hiroshima Prefecture were studied in a cross-sectional study in 2016. Primary outcomes were differences in severity of dementia and ADL among three glycosylated hemoglobin level groups. Secondary end-points included differences in falls, fragility fracture and severe hypoglycemia.Results: Approximately 67.6% of patients receiving any diabetes treatment received dipeptidyl peptidase-4 inhibitors, and 26.0% received sulfonylureas. Patients with glycosylated hemoglobin <7.0% had a significantly higher severity of dementia compared with those with glycosylated hemoglobin 7.0-7.9% (beta AE SE, 0.55 AE 0.26; 95% CI 0.04-1.06) in multivariable ordinal logistic regression analysis. This tendency was observed particularly in patients using insulin (1.91 AE 0.91; 95% CI 0.13-3.69) or both sulfonylureas and dipeptidyl peptidase 4 (2.14 AE 0.88; 95% CI 0.41-3.87). Low body mass index was significantly associated with dementia (−0.08 AE 0.03; 95% CI −0.14 -−0.03) and ADL impairment (−0.15 AE 0.03; 95% CI −0.20 -−0.09), and fractures (odds ratio OR 0.89 per kg/m 2 ; 95% CI 0.84-0.96).Conclusions: Tight glycemic control was related to dementia in residents treated with insulin and sulfonylureas, and low body mass index was associated with dementia, ADL disability and fractures. Optimization of glycemic control and weight for people with diabetes in longterm care facilities could be important for the maintenance of cognitive and physical function.

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A Randomized Controlled Study Comparing a DPP4 Inhibitor (Linagliptin) and Basal Insulin (Glargine) in Patients With Type 2 Diabetes in Long-term Care and Skilled Nursing Facilities: Linagliptin-LTC Trial

Abstract: Treatment with linagliptin resulted in noninferior glycemic control and in significantly lower risk of hypoglycemia compared to insulin glargine in long-term care and skilled nursing facility residents with type 2 diabetes.

Cited by 34 publications

References 39 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

Glycaemic efficacy and safety of linagliptin compared to a basal‐bolus insulin regimen in patients with type 2 diabetes undergoing non‐cardiac surgery: A multicentre randomized clinical trial

Low hemoglobin A1c and low body mass index are associated with dementia and activities of daily living disability among Japanese nursing home residents with diabetes

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