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Insulin Detemir

A Review of its Use in the Management of Diabetes Mellitus

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Abstract

Insulin detemir (Levemir®) is a long-acting insulin analogue indicated for use as basal insulin therapy in patients with type 1 or 2 diabetes mellitus.

The protracted action of insulin detemir is explained by increased self-association and reversible binding to albumin, which slows its systemic absorption from the injection site. In glucose-clamp studies, less within-patient variability in glucose-lowering effect was seen with insulin detemir than with neutral protamine Hagedorn (NPH) insulin or insulin glargine in patients with type 1 or 2 diabetes.

The beneficial effect of insulin detemir on glycaemic control was shown in numerous randomized, open-label, multicentre trials, including when used as basal-bolus therapy in patients with type 1 or 2 diabetes and as basal therapy in addition to oral antidiabetic drugs in insulin-naive patients with type 2 diabetes. In terms of glycosylated haemoglobin (HbA1c) [primary endpoint in most trials], insulin detemir was generally at least as effective as NPH insulin, insulin glargine or insulin lispro protamine suspension in patients with type 1 or 2 diabetes, and at least as effective as biphasic insulin aspart in patients with type 2 diabetes. Less within-patient variability in blood glucose was also generally seen with insulin detemir than with NPH insulin in patients with type 1 or 2 diabetes. Significantly less weight gain was generally seen with insulin detemir than with NPH insulin in patients with type 1 diabetes or with insulin detemir than with NPH insulin, insulin glargine, insulin lispro protamine suspension or biphasic insulin aspart (in one study) in patients with type 2 diabetes (i.e. insulin detemir generally had a weight-sparing effect).

The addition of insulin detemir to liraglutide plus metformin improved glycaemic control in insulin-naive patients with type 2 diabetes and inadequate glycaemic control, although a significantly greater reduction in bodyweight was seen in patients receiving liraglutide plus metformin than in those receiving add-on therapy with insulin detemir.

Results of two trials in patients aged 2–16 or 6–17 years (and a subgroup analysis in children aged 2–5 years) indicate that a basal-bolus insulin regimen incorporating insulin detemir appears to be a suitable option for use in paediatric patients with type 1 diabetes. Less within-patient variation in self-measured fasting plasma glucose was seen with insulin detemir than with NPH insulin in one of the studies.

Insulin detemir was noninferior to NPH insulin in pregnant women with type 1 diabetes in terms of the HbA1c value achieved at 36 gestational weeks. In addition, maternal and neonatal outcomes with insulin detemir were similar to those seen with NPH insulin.

Subcutaneous insulin detemir was generally well tolerated in the treatment of patients with type 1 or 2 diabetes, including in paediatric patients and pregnant women with type 1 diabetes. The majority of adverse events, including serious adverse events, reported in insulin detemir recipients were not considered to be related to the study drug. Insulin detemir was generally associated with a significantly lower risk of nocturnal hypoglycaemia than NPH insulin in patients with type 1 or 2 diabetes, particularly nocturnal minor hypoglycaemia.

In conclusion, insulin detemir is a useful option for use as basal insulin therapy in patients with type 1 or 2 diabetes.

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    Gillian M. Keating

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Correspondence to Gillian M. Keating.

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Various sections of the manuscript reviewed by: M. Evans, Department of Medicine, University Hospital Llandough, Cardiff, Wales; U.M. Kabadi, Department of Medicine, University of Iowa, Iowa City, IA, USA; E. Karnieli, Institute of Endocrinology, Diabetes, and Metabolism, Rambam Medical Center, R.B. Rappaport Faculty of Medicine-Technion, Haifa, Israel; A.D. Mooradian, Department of Medicine, University of Florida College of Medicine, Jacksonville, FL, USA; K. Rasšlová, Metabolic Center Ltd and Slovak Medical University, Bratislava, Slovakia; S.A. Ross, University of Calgary, LMC Endocrinology Centres, Calgary, AB, Canada.

Data Selection

Sources: Medical literature (including published and unpublished data) on ‘insulin detemir’ was identified by searching databases (including MEDLINE and EMBASE) for articles published since 1996, bibliographies from published literature, clinical trial registries/databases and websites (including those of regional regulatory agencies and the manufacturer). Additional information (including contributory unpublished data) was also requested from the company developing the drug.

Search strategy: MEDLINE and EMBASE search terms were ‘insulin detemir’ and (‘diabetes mellitus, type 1’ or ‘insulin dependent diabetes mellitus’ or ‘diabetes mellitus, type 2’ or ‘non insulin dependent diabetes mellitus’ or ‘diabetes mellitus’). Searches were last updated 15 October 2012.

Selection: Studies in patients with type 1 or type 2 diabetes mellitus who received insulin detemir. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Insulin detemir, type 1 diabetes mellitus, type 2 diabetes mellitus, pharmacodynamics, pharmacokinetics, therapeutic use, tolerability.

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Keating, G.M. Insulin Detemir. Drugs 72, 2255–2287 (2012). https://doi.org/10.2165/11470200-000000000-00000

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