OBJECTIVETo assess efficacy and safety of lixisenatide monotherapy in type 2 diabetes.RESEARCH DESIGN AND METHODSRandomized, double-blind, 12-week study of 361 patients not on glucose-lowering therapy (HbA1c 7–10%) allocated to one of four once-daily subcutaneous dose increase regimens: lixisenatide 2-step (10 μg for 1 week, 15 μg for 1 week, and then 20 μg; n = 120), lixisenatide 1-step (10 μg for 2 weeks and then 20 μg; n = 119), placebo 2-step (n = 61), or placebo 1-step (n = 61) (placebo groups were combined for analyses). Primary end point was HbA1c change from baseline to week 12.RESULTSOnce-daily lixisenatide significantly improved HbA1c (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: −0.54% for 2-step, −0.66% for 1-step; P < 0.0001). Significantly more lixisenatide patients achieved HbA1c <7.0% (52.2% 2-step, 46.5% 1-step) and ≤6.5% (31.9% 2-step, 25.4% 1-step) versus placebo (26.8% and 12.5%, respectively; P < 0.01). Lixisenatide led to marked significant improvements of 2-h postprandial glucose levels and blood glucose excursions measured during a standardized breakfast test. A significant decrease in fasting plasma glucose was observed in both lixisenatide groups versus placebo. Mean decreases in body weight (∼2 kg) were observed in all groups. The most common adverse events were gastrointestinal—nausea was the most frequent (lixisenatide 23% overall, placebo 4.1%). Symptomatic hypoglycemia occurred in 1.7% of lixisenatide and 1.6% of placebo patients, with no severe episodes. Safety/tolerability was similar for the two dose regimens.CONCLUSIONSOnce-daily lixisenatide monotherapy significantly improved glycemic control with a pronounced postprandial effect (75% reduction in glucose excursion) and was safe and well tolerated in type 2 diabetes.

The purpose of this study was to estimate the prevalence and risk factors of hypertension in adults indigenous to their traditional communities from the north of Mexico. The study was based on a crosssectional survey of inhabitants from Mexicaneros, Huicholes and Tepehuanos communities, which have not been influenced by a western lifestyle. A home interview and clinical examination that included blood pressure and anthropometric measurements of 217 men and 598 non-pregnant women aged between 35 to 64 years was carried out. Eligible indigenous subjects must have had no migratory history to partially or totally urbanised areas. Target population represented approximately 100% of the indigenous people who have spent all their life time in the community of birthplace. Age and body mass index average was 48.9 ± 12.9 years and 25.6 ± 5.1 kg/m 2 . Hypertension was identified in 56 indi-

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This prospective, multicenter, open-label study assessed the efficacy and tolerability of recombinant human platelet-derived growth factor BB (becaplermin) in the treatment of chronic ulcers of the lower extremities in 73 patients with and without type 2 diabetes mellitus. Becaplermin gel .01% was applied once daily for 12 weeks. Efficacy was assessed in terms of progression to healing (100% epithelialization); the secondary efficacy endpoint was time to complete healing. Safety was assessed in terms of incidence of adverse events. Ninety-five percent of all ulcers were completely healed at week 9; only 5% remained incompletely healed at week 12 and were considered treatment failures. Healing time did not differ between diabetic and nondiabetic patients. The major adverse events were pain, burning sensation, and pruritus at the ulcer site, with an overall incidence of 10%. No patients dropped out because of adverse events. Becaplermin gel .01% was safe and well tolerated. Further studies are necessary to assess the durability of healing with this treatment.

Combinación de un cuestionario autoaplicable con la determinación de glucosa capilar en el tamizaje de diabetes tipo 2.