Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD)

Section of Endocrinology, Yale University School of Medicine, New Haven, Connecticut, USA.
Diabetes care (Impact Factor: 8.42). 04/2012; 35(6):1364-79. DOI: 10.2337/dc12-0413
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    • "glucose and lipid metabolism and ED (Isidori et al., 2005; Corona et al., 2011; Jones et al., 2011; Hackett et al., 2013,2014), while Met, beside its universally well-known antiglycaemic role, is generally considered as a drug with weightneutral effect (Handelsman et al., 2015; Inzucchi et al., 2015), and as not having an intrinsic positive effect on the lipid profile (Wulffel e et al., 2004), it is necessary to point out that we were not able to identify each drug (T or Met) and/or lifestyle changes (or all together those factors) as predominantly having caused those clinical and metabolic improvements. However , in our experience, although that treatment regimen and serum T and its bioavailable fractions (FT and BioT) were in the normal range for adult men (Wang et al., 2008; Bhasin et al., 2010), neither clinical signs (BMI), metabolic parameter (HbA1c, TC and LDL) nor the IIEF score reached those values that were considered as appropriate targets for the treatment in young adult obese subjects affected by T2DM without severe complications (Apovian et al., 2015; Handelsman et al., 2015; Inzucchi et al., 2015; Canadian Diabetes Association Clinical Practice Guidelines Expert Committee, Cheng AY, 2013; Rosen et al., 2002) (Tables 1 and 4). "
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    ABSTRACT: The aim of this retrospective observational study was to evaluate whether adding liraglutide to lifestyle changes, metformin (Met) and testosterone replacement therapy (TRT), by means of improving weight and glycaemic control, could boost erectile function in type 2 diabetic obese men with overt hypogonadism and erectile dysfunction (ED) in a 'real-life setting'. Forty-three obese, diabetic and hypogonadal men (aged 45-59 years) were evaluated because of complaining about the recent onset of ED. They were subdivided into two groups according to whether hypogonadism occurred after puberty (G1; n = 30: 25 with dysfunctional hypogonadism and 5 with acquired hypogonadotropic hypogonadism) or before puberty (G2; n = 13: 10 with Klinefelter's syndrome and 3 with idiopathic hypogonadotropic hypogonadism). Both G1 and G2 patients were given a combination of testosterone (T) [testosterone undecanoate (TU) 1000 mg/every 12 weeks] and Met (2000-3000 mg/day) for 1 year. In the poor responders (N) to this therapy in terms of glycaemic target (G1N: n = 16; G2N: n = 10), liraglutide (L) (1.2 μg/day) was added for a second year, while the good responders (Y) to T + Met (G1Y: 14/30 and G2Y: 3/13) continued this two drugs regimen therapy for another year. All patients were asked to fill in the International Index of Erectile Function (IIEF 15) questionnaire before starting TU plus Met (T1) and after 12 months (T2) and 24 months (T3) of treatment. Patients underwent a clinical examination and a determination of serum sex hormone binding globulin (SHBG), total testosterone (T) and glycosylated haemoglobin (HbA1c) at T1, T2 and T3. At T2, each patient obtained an improvement of ED (p < 0.01) and of the metabolic parameters without reaching, however, the glycaemic goals [HbA1c = >7.5% (>58 mmol/mol)], while T turned out to be within the range of young men. L added to TU and Met regimen in G1N and G2N allowed these patients to reach not only the glycaemic target [HbA1c = <7.5% (<58 nmol/mol)] and a significant reduction in body weight (p < 0.01), but also a further increase in SHBG (p < 0.05) and T (p < 0.01) plasma levels as well as a significant increment of IIEF score (T3). Conversely, at T3 G1Y and G2Y, who received the combined therapy with TRT and Met for the second year, showed a partial failure of that treatment given that there was no improvement of the IIEF score and they showed a significant rise in serum HbA1c (p < 0.05) and weight (p < 0.04) compared with the assessments at T2. These results suggest that TRT could improve clinical and metabolic parameters in obese, type 2 diabetic men with ED and overt hypogonadism (independently of when T deficit occurred). Furthermore, in case of insufficient metabolic control the addition of L to TRT and Met regimen allows to achieve serum T levels in the range of healthy men, as well as to reach glycaemic target and to lower weight, leading to a considerable improvement of ED.
    Andrology 10/2015; DOI:10.1111/andr.12099 · 2.30 Impact Factor
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    • "One strategy initiated insulin therapy with one injection a day of the basal insulin, insulin glargine, and added one injection of insulin glulisine, a rapid-acting insulin before the main meal if glycemic control was insufficient. This strategy (basal-plus) is a recommended second step when basal insulin is insufficient to achieve the therapeutic goal (Handelsman et al., 2011; International Diabetes Federation: IDF Clinical Guidelines Task Force, 2012; Inzucchi et al., 2012). The other strategy initiated insulin therapy with one or two injections of premixed insulin as needed. "
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    • "Evidence-based literature focusing on hyperglycemic emergencies associated with DM was also reviewed using major databases. Existing protocols from the literature were used to evaluate the EHR for adherence to the most contemporary evidence related to the diagnosis and treatment of HHNKS (Inzucchi et al., 2012; Kitabchi et al., 2008 "
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