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Diabetes Obes Metab. 2019 Jul 12. doi: 10.1111/dom.13829. [Epub ahead of print]

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

Author information

1
Arlington Family Health Pavilion, PA, Arlington, TX, USA.
2
Department of Medicine, Emory University, Atlanta, GA, USA.
3
Division of Geriatric Medicine, Saint Louis University, St. Louis, MO, USA.
4
Merck & Co. Inc., Kenilworth, NJ, USA.
5
Global BDS, Boehringer Ingelheim Pharma GmbH & Co, KG, Ingelheim, Germany.
6
TA CardioMetabolism, Boehringer Ingelheim International GmbH, Biberach, Germany.
7
International Project Management Cardiometabolic/CNS, Boehringer Ingelheim International GmbH, Ingelheim, Germany.
8
TA CardioMetabolism, Boehringer Ingelheim International GmbH, Ingelheim, Germany.

Abstract

AIMS:

Intensification of glucose-lowering therapy in elderly patients with type 2 diabetes mellitus (T2DM) receiving insulin can be challenging due to the increased risk of hypoglycemia. We assessed the addition of linagliptin as an alternative to insulin up-titration in these individuals.

MATERIALS AND METHODS:

This phase 4, randomized, multicenter, double-blinded, placebo-controlled, 24-week study recruited individuals on stable insulin, with baseline glycated hemoglobin (HbA1c) 7.0-10.0%, age ≥60 years, and body mass index ≤45 kg/m2 . HbA1c and fasting plasma glucose were measured at study visits, and participants assessed glycemic control with a self-monitoring blood glucose device. Adverse events (AEs) were reported during the study.

RESULTS:

302 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 ≥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 versus placebo: -0.63%; p<0.0001), and the likelihood of achieving predefined HbA1c targets without hypoglycemia (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 hypoglycemia (blood glucose <54 mg/dl) or severe hypoglycemia.

CONCLUSIONS:

Addition of linagliptin improves glucose control without an excess of hypoglycemia in older patients with T2DM on stable insulin therapy. This article is protected by copyright. All rights reserved.

KEYWORDS:

Basal insulin; Clinical Trial; DPP-4 inhibitors; Hypoglycemia; Linagliptin; Type 2 diabetes

PMID:
31297968
DOI:
10.1111/dom.13829

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