OBJECTIVEMealtime insulin is commonly added to manage hyperglycemia in type 2 diabetes when basal insulin is insufficient. However, this complex regimen is associated with weight gain and hypoglycemia. This study compared the efficacy and safety of exenatide twice daily or mealtime insulin lispro in patients inadequately controlled by insulin glargine and metformin despite up-titration. RESEARCH DESIGN AND METHODSIn this 30-week, open-label, multicenter, randomized, noninferiority trial with 12 weeks prior insulin optimization, 627 patients with insufficient postoptimization glycated hemoglobin A 1c (HbA 1c ) were randomized to exenatide (10-20 mg/day) or thrice-daily mealtime lispro titrated to premeal glucose of 5.6-6.0 mmol/L, both added to insulin glargine (mean 61 units/day at randomization) and metformin (mean 2,000 mg/day). RESULTSRandomization HbA 1c and fasting glucose (FG) were 8.3% (67 mmol/mol) and 7.1 mmol/L for exenatide and 8.2% (66 mmol/mol) and 7.1 mmol/L for lispro. At 30 weeks postrandomization, mean HbA 1c changes were noninferior for exenatide compared with lispro (-1.13 and -1.10%, respectively); treatment differences were -0.04 (95% CI -0.18, 0.11) in per-protocol (n = 510) and -0.03 (95% CI -0.16, 0.11) in intent-to-treat (n = 627) populations. FG was lower with exenatide than lispro (6.5 vs. 7.2 mmol/L; P = 0.002). Weight decreased with exenatide and increased with lispro (22.5 vs. +2.1 kg; P < 0.001). More patients reported treatment satisfaction and better quality of life with exenatide than lispro, although a larger proportion of patients with exenatide experienced treatment-emergent adverse events. Exenatide resulted in fewer nonnocturnal hypoglycemic episodes but more gastrointestinal adverse events than lispro. CONCLUSIONSAdding exenatide to titrated glargine with metformin resulted in similar glycemic control as adding lispro and was well tolerated. These findings support exenatide as a noninsulin addition for patients failing basal insulin.

By direct sequencing, we have discovered a novel heteroplasmic mutation (T-->C) at nucleotide position 8993 in the mitochondrial ATPase 6 gene in a family with Leigh's syndrome. Another mutation in the same codon (T8993G) has been reported before in Leigh's syndrome. As these two mutations led to different amino acid substitutions, it provides strong evidence for the relevance of ATP synthase dysfunction in maternally inherited Leigh's syndrome.

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Objective To explore women's traumatic childbirth experiences in order to make maternity care professionals more aware of women's intrapartum care needs. Method A qualitative exploratory study with a constant comparison/grounded theory design was performed. Thirty‐six interviews were conducted with women who had given birth in a Dutch birth setting. Findings Three themes, playing a profound role in the occurrence of traumatic birth experiences, emerged: (i) lack of information and consent – maternity care professionals' unilateral decision making during intrapartum care, lacking informed‐consent. (ii) feeling excluded – women's mal‐adaptive response to the healthcare professionals's one‐sided decision making, leaving women feeling distant and estranged from the childbirth event and the experience. (iii) discrepancies – inconsistency between women's expectations and the reality of labour and birth – on an intrapersonal level. Conclusion Women's intrapartum care needs cohere with the concept of woman‐centred care, including personalised care and reflecting humanising values. Care should include informed consent and shared decision‐making. Maternity care professionals need to continuously evaluate whether the woman is consistently part of her own childbearing process. Maternity care professionals should maintain an ongoing dialogue with the woman, including women's internalised ideas of birth.