Changing basal insulin from NPH to detemir or glargine in patients with type 1 diabetes and a history of severe hypoglycemia

Abstract

Background:The insulin analogs, glargine and detemir, are associated with reduced hypoglycemia incidence compared with NPH insulin. We assessed the impact of changing basal insulin from NPH to glargine or detemir in patients with type 1 diabetes mellitus who experienced severe hypoglycemia. Material and methods: A retrospective chart review was conducted that included 73 (31 female) patients (mean age 48 years, diabetes duration 19 years) treated for 12 to 24 months with insulin glargine (n = 43) or detemir (n = 30). Results: There were no patients who withdrew from treatment due to side effects. The mean treatment duration in both groups was 18 months. Changing from NPH insulin was associated with a −0.3% (p = 0.036) reduction in HbA1c for glargine (baseline 8.8%) and −0.4% (p = 0.040) for detemir (baseline 8.3%) treated patients; insulin dosages increased, respectively by 4.1 (p = 0.045) and 4.3 units (p = 0.004) (mean values). Weight did not increase signifi cantly and the 1-year rate of serious hypoglycemia was 0.25/person/year. Conclusion: Switching from NPH-insulin to insulin detemir or glargine in type 1 diabetes mellitus patients with previous serious hypoglycemia was associated with a reduction in HbA1c. However, severe hypoglycemia was not completely eliminated, and few patients reached internationally accepted glycemic treatment goals. Literature search: We searched Medline, PubMed (with key search terms type 1 diabetes, NPH insulin, detemir, glargine and serious hypoglycemia), reference lists and databases of ongoing and completed trials (through July 2008) provided from the manufacturers of the drugs to identify relevant literature. Keywords: type 1 diabetes mellitus, insulin, observational study, HbA1c, effi cacy IntroductionNeutral protamine Hagedorn (NPH) insulin is the most widely used basal insulin worldwide.1 However, NPH insulin may not be the optimal basal insulin due to its signifi cant day-to-day variability, bell-shaped effect curve and estimated 12-to 15-hour duration of action. 2,3 In addition, being a suspension of crystals, it needs proper re-suspension, a fact that is often disregarded by patients. 4 These characteristics of NPH-insulin render patients more prone to hypoglycemia and usually require the users to be on a twice daily injection schedule to attain 24-hour basal insulin coverage.3 NPH insulin is also associated with weight gain, 5 thus further reducing potential compliance. 6These are all factors that are barriers for achieving good glycemic control. These shortcomings of NPH insulin spurred the development of other basal insulin formulations, of which two are currently marketed: insulin glargine (Lantus ®; Sanofi Aventis, France); and insulin detemir (Levemir 122Johansen et al acylated with a fatty-acid chain (myristic acid) to the lysine at residue B29 of the insulin molecule which mediates albumin binding in the interstitial fl uid and plasma. 2,8,9 Both come in a clear solution and do not require re-suspension.Although none of the basal insulin analogs have a complete...

The outcome of care in people with type 1 diabetes after switching to insulin glargine-based regimens in a real-life setting: a long-term observational study

“…Data from other studies are divergent. In some of them, basal insulin dose decreased (24,35,36,38), in some did not changed significantly (27,(30)(31)(32)37), while in another increased (22,26). Prandial insulin requirement increased significantly in only one study (36); in the remaining studies, no significant change was observed (22,24,(30)(31)(32)35,37,38).…”

“…In the previous study involving partially population followed up in this study, significant reduction in HbA 1c from 8.99% (74.8 mmol/mol) to 8.36% (67.9 mmol/mol) was noticed (24). In the vast majority of other observational studies, both retro-spective and prospective, switch to insulin glargine was associated with significant reduction in HbA 1c level by 0.13-0.7% (25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35). In two studies, despite improvement in metabolic control, statistical significance was not reached (36,37).…”

Insulin Analogues: Reviewing the Pros and Cons in Managing Diabetes Mellitus

“…As the insulin analogues glargine and detemir display a flatter pharmacokinetic profile suggesting a clinically significant reduction in hypoglycaemia incidence compared with NPH insulin, most studies have only shown a small reduction in nocturnal hypoglycaemic incidence leaving the "fear of hypoglycaemia to remain. A recent study in patients with type 1 diabetes mellitus with severe hypoglycaemia on NPH who were changed to glargine or detemir still experienced severe hypoglycaemia and few patients reached internationally accepted glycaemic treatment goals [35]. In fact a Cochrane review article showed no glycaemic benefit of long-acting insulin analogues compared with intermediate-acting insulin [36].…”

Ny insulin kan gi økt trygghet og stabilitet

“…Det har en klokkeformet virkningskurve, betydelig dag til dag-variasjon i virkningen etter injeksjonen og foreligger som en suspensjon som må blandes svaert godt før injeksjon (4). Av hurtigvirkende-eller måltidsinsulin er det mest vanlig å bruke de ekstra hurtigvirkende insulinanalogene.…”

“…Brukernes tilfredshet og uttrykk for større forutsigbarhet med hensyn til insulinvirkningen bør også tas med i vurderingen av hvilken insulinbehandling som er den beste i hvert enkelt tilfelle (4 …”