Low-Dose Insulin as an Antiscarring Therapy in Breast Surgery: A Randomized Controlled Trial.

BACKGROUND: The role of insulin in expediting wound healing is firmly established within the context of major trauma and burns; however, only limited clinical evidence exists as to its effects on scar formation. This study aims to build on previous laboratory work to examine the potential antiscarring properties of insulin in a clinical environment. METHODS: Ninety-one patients undergoing bilateral aesthetic breast operations were recruited to receive low-dose insulin and placebo injections to the medial 3 cm of their submammary incisions within the context of a randomized, intrapatient, placebo-controlled trial, and scar quality was assessed at 3-, 6-, and 12-month reviews using the Manchester Scar Scale. RESULTS: Across the cohort at 12-month review, the insulin-treated scars had lower scar scores (p = 0.055) compared with placebo. Subgroup analysis of individuals with heavier scars showed that median scar scores were significantly lower for the insulin-treated scars with regard to both scar contour (p = 0.048) and scar distortion (p = 0.045). CONCLUSIONS: Subcutaneous insulin injections reduced the appearance of scarring in this study compared with placebo. The greatest effect was seen in those participants who showed heavier scars and, as such, insulin has a role as an antiscarring therapy in individuals likely to be affected by heavier scarring. Further research is required to more precisely delineate which subjects may benefit most from this treatment. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Effect of oral supplementation of composite leaf extract of medicinal plants on biomarkers of oxidative stress in induced diabetic Wistar rats.

Present study was conducted to evaluate the effect of oral supplementation of composite extract of leaves (CLE) of four medicinal plants; Aegle marmelos, Ocimum sanctum, Murraya koenigii and Azadirachta indica on markers of oxidative stress in brain tissues of alloxan-induced diabetic rats in vivo. Enhanced lipid peroxidation, protein oxidation and reduced antioxidative defence systems were measured in brain tissues of diabetic rats. Supplementation of CLE, once in a day for 35 days significantly (p < .05) protected the peroxidation of lipid, oxidation of protein and ameliorated the antioxidant defence in brain tissue of diabetic rats. It was observed that the insulin-like effect of CLE was dose dependent; higher effect at higher doses. The results of the study suggest that supplementation CLE may provide an overall homeostasis and significant neuro-protection through rescuing brain cells from oxidative abuse and accelerating brain antioxidative defence during advanced stage of hyperglycaemia.

Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus.

OBJECTIVE: To compare the effects of the neutral protamine Hagedorn (NPH) recombinant human insulin formulations Gansulin and Humulin N® on the glycemic control of patients with type 2 diabetes mellitus (T2DM). SUBJECTS AND METHODS: Prospective, double-blind, randomized, parallel, single-center study of 37 individuals with T2DM treated with NPH insulin formulations. The Tukey-Kramer test for multiple comparisons, the Wilcoxon paired comparison test and the Chi-Square test were used for the statistical analyses. The significance level was set at 5% (p < 0.05). RESULTS: The NPH insulin formulations Humulin and Gansulin similarly reduced the HbA1c levels observed at the end of the study compared with the values obtained at the beginning of the study. In the Humulin group, the initial HbA1c value of 7.91% was reduced to 6.56% (p < 0.001), whereas in the Gansulin group, the reduction was from 8.18% to 6.65% (p < 0.001). At the end of the study, there was no significant difference between the levels of glycated hemoglobin (p = 0.2410), fasting plasma glucose (FG; p = 0.9257) and bedtime plasma glucose (BG; p = 0.3906) between the two insulin formulations. There was no nt difference in the number of hypoglycemic events between the two insulin formulations, and no severe hyp episodes were recorded. CONCLUSION: This study demonstrated similar glycemic control by NPH insulin Gansulin compared with human insulin Humulin N® in patients with T2DM.

Comparative study between two recombinant human NPH insulin formulations for the treatment of type 2 diabetes mellitus

ABSTRACT Objective To compare the effects of the neutral protamine Hagedorn (NPH) recombinant human insulin formulations Gansulin and Humulin N® on the glycemic control of patients with type 2 diabetes mellitus (T2DM). Subjects and methods Prospective, double-blind, randomized, parallel, single-center study of 37 individuals with T2DM treated with NPH insulin formulations. The Tukey-Kramer test for multiple comparisons, the Wilcoxon paired comparison test and the Chi-Square test were used for the statistical analyses. The significance level was set at 5% (p < 0.05). Results The NPH insulin formulations Humulin and Gansulin similarly reduced the HbA1c levels observed at the end of the study compared with the values obtained at the beginning of the study. In the Humulin group, the initial HbA1c value of 7.91% was reduced to 6.56% (p < 0.001), whereas in the Gansulin group, the reduction was from 8.18% to 6.65% (p < 0.001). At the end of the study, there was no significant difference between the levels of glycated hemoglobin (p = 0.2410), fasting plasma glucose (FG; p = 0.9257) and bedtime plasma glucose (BG; p = 0.3906) between the two insulin formulations. There was no nt difference in the number of hypoglycemic events between the two insulin formulations, and no severe hyp episodes were recorded. Conclusion This study demonstrated similar glycemic control by NPH insulin Gansulin compared with human insulin Humulin N® in patients with T2DM.

Glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus insulin glargine 100 U/ml in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs: the EDITION 2 randomized 12-month trial including 6-month extension.

AIMS: To compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) over 12 months of treatment in people with type 2 diabetes using basal insulin and oral antihyperglycaemic drugs (OADs). METHODS: EDITION 2 (NCT01499095) was a randomized, 6-month, multicentre, open-label, two-arm, phase IIIa study investigating once-daily Gla-300 versus Gla-100, plus OADs (excluding sulphonylureas), with a 6-month safety extension. RESULTS: Similar numbers of participants in each group completed 12 months of treatment [Gla-300, 315 participants (78%); Gla-100, 314 participants (77%)]. The reduction in glycated haemoglobin was maintained for 12 months with both treatments: least squares (LS) mean (standard error) change from baseline -0.55 (0.06)% for Gla-300 and -0.50 (0.06)% for Gla-100; LS mean difference -0.06 [95% confidence interval (CI) -0.22 to 0.10)%]. A significant relative reduction of 37% in the annualized rate of nocturnal confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia was observed with Gla-300 compared with Gla-100: rate ratio 0.63 [(95% CI 0.42-0.96); p = 0.031], and fewer participants experienced ≥1 event [relative risk 0.84 (95% CI 0.71-0.99)]. Severe hypoglycaemia was infrequent. Weight gain was significantly lower with Gla-300 than Gla-100 [LS mean difference -0.7 (95% CI -1.3 to -0.2) kg; p = 0.009]. Both treatments were well tolerated with a similar pattern of adverse events (incidence of 69 and 60% in the Gla-300 and Gla-100 groups). CONCLUSIONS: In people with type 2 diabetes treated with Gla-300 or Gla-100, and non-sulphonylurea OADs, glycaemic control was sustained over 12 months, with less nocturnal hypoglycaemia in the Gla-300 group.

Association between hypoglycemia and the type of insulin in diabetic patients treated with multiple injections: an observational study.

INTRODUCTION: Hypoglycemia may have serious health consequences; therefore, it is important to expand knowledge on the factors that increase its prevalence. OBJECTIVES: The aim of the study was to evaluate the effect of the type of insulin-human vs. analogue-on the incidence of mild and severe hypoglycemia, body weight, and hemoglobin A1c (HbA1c) levels. PATIENTS AND METHODS: A total of 203 diabetic patients treated with intensive insulin therapy completed the questionnaire on hypoglycemia at baseline and at 3 and 6 months of the follow­up. Body weight and HbA1c levels were measured at baseline and at 6 months. Incidence of mild and severe hypoglycemia, body weight, and HbA1c levels were compared between patients treated with short­acting analogue and those treated with short­acting human insulin (regardless of the type of long­acting insulin used) and between patients receiving short- and long­acting analogue insulin and those receiving short- and long­acting human insulin. A multiple logistic regression analysis was used to find independent risk factors of severe hypoglycemia. RESULTS: At baseline, mild hypoglycemia was more common in patients receiving insulin analogue. There were no differences between the subgroups in the incidence of severe hypoglycemia, HbA1c levels, and body weight. Male sex, older age, and the dose of long­acting insulin were independently associated with a higher incidence of severe hypoglycemia. Type 2 diabetes and higher body weight were associated with a lower risk of severe hypoglycemia. CONCLUSIONS: Our results suggest that use of insulin analogues may predispose to more frequent episodes of mild hypoglycemia, but it does not increase the incidence of severe hypoglycemia in patients on intensive insulin therapy. Insulin analogues are not different from human insulin in terms of the effects on HbA1c levels and body mass.