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Fiesselmann A.,Diabetologische Schwerpunktpraxis | Wiesner T.,MVZ Stoffwechselmedizin Leipzig | Fleischmann H.,Sanofi S.A. | Bramlage P.,Institute For Pharmakologie Und Praventive Medizin
Acta Diabetologica | Year: 2016

Aims: The addition of a single injection of insulin to the oral drugs (basal supported oral therapy; BOT) has been shown to greatly reduce blood glucose levels. The intermediate-acting NPH insulin (NPH) and the long-acting insulin glargine (Lantus®) have been compared for use in BOT in numerous clinical trials; however, their efficacy and safety in a real-life setting have not been described. Methods: TIP (therapeutic benefits of patients on insulin glargine vs. NPH insulin being poorly controlled on prior short-time basal-insulin supported therapy with NPH insulin or insulin glargine) is a non-interventional, multicentre, observational study over 24 weeks. A total of 2629 patients were enrolled and 1931 were fully evaluable (1614 insulin glargine, 303 NPH insulin). Propensity scoring (PSM) was used to match 570 patients into 2 similar cohorts of 285 patients. Results: In the PSM cohort, a slightly greater reduction in FBG and HbA1c levels was seen in the insulin glargine group compared to the NPH group. A weight loss, which was slightly more pronounced in insulin glargine patients despite receiving a lower insulin dose relative to the NPH group, was seen in both the groups. Additionally, hypoglycaemia, including nocturnal and severe events, was more prevalent in the patients receiving BOT with NPH. The occurrence of new micro- or macro-vascular complications and adverse events was low for both groups. A large proportion of patients changed from NPH therapy to insulin glargine therapy during the study, which was mainly attributable to insufficient glucose modulation. Improvements in quality of life and treatment satisfaction were found for both types of insulin. Conclusions: This observational study provides evidence from a real-life setting that BOT with insulin glargine provides slightly greater reductions in weight, FBG and HbA1c levels, with a lower risk of hypoglycaemia than patients receiving NPH. This conclusion indicates that insulin glargine may be preferable to NPH insulin for BOT. © 2016 Springer-Verlag Italia

Tanudjaja T.,Diabetologische Schwerpunktpraxis | Spraul M.,Diabetes Zentrum Rheine
Diabetologe | Year: 2015

Background: The number of scientific publications on the diabetic foot has significantly risen in the last 10 years. Materials and methods: The most important contributions published in 2014 dealing with the diabetic foot were selected. The backgrounds of several clinically relevant publications are presented together with the methods and results. Implications for daily practice are provided. Results: Based on the diagnosis-related group (DRG) system, the number of major amputations in Germany has decreased in recent years. In the last 20 years, the risk for amputation for people with diabetes has decreased more than for people without diabetes. There are indications that the cost of care for patients with diabetic foot have also declined. A long delay in treating a diabetic foot represents an increased risk for amputation and mortality. Intense patient education is essential to improve the self-assessment for the patient and to reduce the amputation rate in patients at high risk of diabetic foot. Chronic plantar ulcers are very common. One study concluded that appropriate footwear and treating nonulcerative skin lesions are effective measures to reduce this significant risk for chronic ulcers. Several studies investigated the selection of the antibiotic therapy for infected diabetic foot. Especially in view of the increasing number of cases with severe Clostridium difficile-associated diarrhea and increased development of resistance, strict hygiene and careful selection of the antibiotic are necessary. © 2015, Springer-Verlag Berlin Heidelberg.

Background: Insulin glulisine has a more rapid onset of action than other fast-acting insulin analogues, which has a beneficial effect on postprandial glucose regulation. The objective was to compare the incidence of macro-and microvascular outcomes in type 2 diabetes patients treated with either insulin glulisine or other short-acting analogues under real-life conditions. Patients and Methods: Data from 732 type 2 diabetes patients with glulisine and 2196 users of other analogues in general practices (Disease Analyzer database; 11/2004 to 01/2011) were retrospectively analyzed after matching for age (61 ± 10 years) and gender (men: 51 %). Hazard ratios (HR, Cox regression) for macro- and microvascular outcomes (follow-up: 3.5 years) were adjusted for type of physician (diabetologist) and region, antidiabetic co-medication (basal insulin, oral hypoglycemic agents), hypertension, hyperlipidemia, previous treatment with short-acting insulins, lipid-lowering drugs, antihypertensives, aspirin use, and the Charlson comorbidity index. Results: A reduced risk (22 %) of macrovascular events was found in patients with insulin glulisine compared to other rapid-acting analogues (p = 0.01). In particular, a decreased risk of coronary heart disease (HR, 95 %; CI: 0.72, 0.57 to 0.98) and incident stroke or TIA (0.66, 0.44 to 0.98) was observed. There was also a trend for a decreased risk (0.76, 0.56 to 1.03) for incident retinopathy, whereas for nephropathy and neuropathy no differences were observed. Conclusions: Treatment with insulin glulisine in type 2 diabetic patients is associated with a reduced incidence of macrovascular events compared to other rapid-acting insulin analogues. These results from a retrospective observational study must be verified by a randomized prospective controlled trial. © Georg Thieme Verlag KG Stuttgart · New York.

Today, about 6% of the world population suffer from type 2 diabetes - with an increasing incidence. Since diabetes is a major cause for an enhanced mortality due to macro- and microangiopathic comorbidities, the effective treatment of glycemic goals has become a top priority of all available antidiabetic therapies. However, avoiding adverse events such as major hyperglycemia or strong weight gain is essential. Unfortunately, these are therapy limiting conditions that occur with most of the available treatment opportunities. Furthermore, most of the treatments cannot delay the two underlying pathophysiologic defects of the disease - the progressive β-cell dysfunction and the insulin resistance. Hence, many physicians and patients concentrate their attention on the recently approved incretin-based therapies, mainly the GLP-1-mimetics. Hitherto, exenatide has gained approval for its use in patients with type 2 diabetes. Another GLP-1 agonist is liraglutide which gained approval in June 2009. The results of the phase 3 LEAD program have been presented recently. The present publication wants to give a short overview of the new GLP-1-mimetics and tries to assess the risk-benefit ratio, based on the available data and the current recommendations of ADA and EASD.

Danne T.,Bult Diabetes Center for Children and Adolescents | Forst T.,IKFE Institute for Clinical Research and Development | Deinhard J.,Accovion GmbH | Rose L.,Diabetologische Schwerpunktpraxis | And 2 more authors.
Journal of Diabetes Science and Technology | Year: 2012

Background: Injection compliance is a major problem in patients with type 1 diabetes. Increased compliance with mealtime insulin injections significantly improves metabolic control. Using an insulin pen with memory function might facilitate corrective dosing to avoid postprandial blood glucose peaks and therefore might improve overall glycemic control. Methods: This randomized, open-label, 24-week multicenter study evaluated if patients with inadequately controlled type 1 diabetes [hemoglobin A1c (HbA1c) ≥ 8%] who were randomized to use the HumaPen® Memoir™, an insulin pen device with memory function, for their mealtime insulin injections achieved superior glycemic control (HbA1c change from baseline) than patients who used the conventional device HumaPen Luxura™. Hemoglobin A1c, hypoglycemia, and pen acceptance were assessed at baseline and after 12 and 24 weeks. Results: Of 263 patients randomized, 257 were eligible for analysis: HumaPen Memoir 129, HumaPen Luxura 128; mean [standard deviation (SD)] baseline HbA1c 9.09% (0.99%); mean (SD) age 39.8 (16.5) years; 87.9% ≥18 years old; and mean (SD) diabetes duration 16.0 (11.2) years. Least square mean (95% confidence interval) changes of HbA1c up to week 24 were not significantly different between the HumaPen Memoir [0.43% (-0.59%,-0.28%)] and the HumaPen Luxura group [0.48% (0.64%, 0.32%); p = . 669]. The overall incidence of hypoglycemic episodes did not differ significantly between groups (p = . 982). Average satisfaction with insulin delivery was high in both groups. Conclusions: In this patient sample, usage of a memory function pen was not associated with superior glycemic control, suggesting that adherence to mealtime injection schedules was not improved in a relevant manner. The memory function might be helpful for specific patient populations only, e.g., children or forgetful patients. © Diabetes Technology Society.

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