Capsaicin: A Therapeutic Option for Painful Diabetic Neuropathy

Fifteen patients with diabetes mellitus who had painful diabetic neuropalhy (PDN) were enrolled in a double-blind study to test the safety and efficacy of capsaicin 0.075% (Axsain, Genderm, Northbrook, IL). Twelve of the 15 patients completed the eight-week sludy. Nine of the 12 patients reported symptomatic relief; of these nine, five used the drug and four used the vehicle. The three patients who reported no relief of symptoms applied the vehicle. Capsaicin is potentially effective when burning pain is a major symptom of PDN. The side effects of capsaicin were limited and minimal. This agent should be considered by clinicians for treatment of PDN

Experience with Biosynthetic Human Insulin in Diabetes

Thirty diabetic patients new to insulin were entered in an open label prospective study of biosynthetic human insulin (BHI). All patients experienced symptomatic control of diabetes attributable to dietary and BHI insulin therapy. Detailed six-month evaluation data were reviewed in 19 patients. A significant drop in fasting plasma glucose and glycosylated hemoglobin was noted at two months, and a further modest decrease occurred at six months. E. coli polypeptide antibodies were unchanged from baseline at six months, indicating that no bacterial protein contamination of BHI occurred. Percent binding of serum antibodies to human insulin measured in 19 patients at baseline and at six months showed a statistically significant increase in mean value without accompanying clinical symptoms. Clinical hypoglycemia did not differ from that seen in patients who received animal insulin. Biosynthetic human insulin appears comparable in clinical efficacy and safety to purified pork insulin. Ongoing studies will be required to determine whether BHI is less immunogenic than purified pork insulin

Comparison of a Novel Insulin Bolus-Patch with Pen/Syringe Injection to Deliver Mealtime Insulin for Efficacy, Preference, and Quality of Life in Adults with Diabetes: A Randomized, Crossover, Multicenter Study

Objective: This study compared the efficacy, safety, device satisfaction, and quality of life (QOL) in people with diabetes using an insulin bolus-patch versus current devices (pen/syringe) to deliver mealtime insulin. Research Design and Methods: Thirty-eight subjects with diabetes (26 with type 1 and 12 with type 2) were randomized to bolus-patch or current injection device (55% pen and 45% syringe) to deliver mealtime insulin in a multicenter, 6-week crossover study. Efficacy was assessed by equivalence in mean daily seven-point blood glucose (MDBG). Safety assessments included severe hypoglycemia episodes, adverse device effects (ADEs), and adverse events (AEs). Device satisfaction was determined by the validated Insulin Delivery System Rating Questionnaire (IDSRQ) and QOL by the validated Diabetes Specific QOL Scale (DSQOLS). Results: Using bolus-patch, MDBG (mean•SE) was equivalent to that using pen/syringe (8.61+/-0.28 vs. 9.02+/-0.26-mmol/L; P=0.098). SD of the seven-point blood glucose measurements was lower using bolus-patch (3.18+/-0.18 vs. 3.63+/-0.17 mmol/L; P=0.004), as was the coefficient of variation (CV) (37.2+/-1.7 vs. 40.3+/-1.7%; P=0.046). Hemoglobin A1c, 1,5-anhydroglucitol, fructosamine, and insulin use were similar between groups. There were no severe hypoglycemia episodes or serious ADEs. Between-device AEs were comparable. Subjects scored better on six of seven subscales on the DSQOLS and five of six subscales on the IDSRQ while using bolus-patch versus pen/syringe. At study completion, 76% of subjects would choose to switch to bolus-patch (P=0.001). Conclusions: Delivery of mealtime insulin with bolus-patch compared with pen/syringe resulted in equivalent MDBG, lower SD and CV of seven-point blood glucose measurements, good safety, significant device satisfaction, and improved QOL.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/90477/1/dia-2E2011-2E0047.pd