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Bondy, France

Guerci B.,Nancy University Hospital Center | Monnier L.,Institut Universitaire de France | Petit C.,Sud Francilien Hospital | Valensi P.,Paris Nord University | And 5 more authors.
Diabetes and Metabolism | Year: 2012

Aim: To compare continuous glucose monitoring (CGM) profiles on vildagliptin versus sitagliptin in addition to metformin, in patients with inadequately controlled type 2 diabetes mellitus (HbA1c 6.5-8.0%). Methods: A multicenter, prospective, randomised, open-label study with blinded endpoint analysis. CGM data acquired over three days - firstly on metformin alone and then 8 weeks after the addition of either vildagliptin (n=14) or sitagliptin (n=16) -were blinded and analyzed centrally. Results: In comparable populations with a mean baseline HbA1c of 7.1%, 24-hour glucose variability - measured by mean amplitude of glucose excursions and standard deviation of mean glucose concentration - showed similar improvement on both drugs versus metformin alone. In contrast, a series of predefined parameters reflecting daily glycaemic control - mean 24-hour blood glucose concentration, and the times spent in the optimal glycaemic range (70-140 mg/dL) and above the hyperglycaemic thresholds of 140 and 180 mg/dL together with the corresponding AUC values - were significantly improved from baseline only in the vildagliptin arm. In addition, overall hyperglycaemia (AUC[24h] >100mg/dL) significantly dropped from baseline on vildagliptin [-37%] but not on sitagliptin [-9%], while postprandial hyperglycaemia (AUC[0-4h]×3) was significantly reduced on both, and basal hyperglycaemia (overall - postprandial hyperglycaemia was reduced only on vildagliptin [-41%; P=0.04]). Conclusions: The addition of a DPP-4 inhibitor significantly reduced glycaemic variability with no difference between the two drugs. However, vildagliptin induced better circadian glycaemic control than sitagliptin with a significant decrease on overall hyperglycemia, mainly driven by reduction on basal hyperglycaemia. © 2012 Elsevier Masson SAS. Source

Kawamori R.,Juntendo University | Valensi P.,Paris Nord University
Expert Review of Endocrinology and Metabolism | Year: 2010

The IMPROVETM study is the largest observational study of therapy in Type 2 diabetes mellitus to date. It is a multinational study investigating the safety and efficacy of biphasic insulin aspart 30/70 (BIAsp 30) in the routine management of patients with Type 2 diabetes mellitus. Five published reports on this study have provided baseline demographic information for patients receiving BIAsp 30 in eight countries, information on the safety and efficacy outcomes for those patients and analyses of three subgroups of patients who were insulin-naive, receiving basal insulin or receiving biphasic human insulin before the start of the study. These subanalyses provided information on the optimal prescribing and dosing strategies when starting treatment with BIAsp 30 in these groups of patients in normal clinical practice. The study extends the results from clinical trials of BIAsp 30 and confirms its benefits in routine care, in a large, global, heterogeneous patient population. © 2010 Expert Reviews Ltd. Source

Liebl A.,Fachklinik Bad Heilbrunn | Prusty V.,Novo Nordisk AS | Valensi P.,Paris Nord University | Kawamori R.,Juntendo University | And 5 more authors.
Drugs | Year: 2012

Biphasic insulin aspart 30 (BIAsp 30) includes 30 soluble rapid-acting insulin aspart (IAsp) along with an intermediate-acting 70 protaminated IAsp that provides coverage of prandial and basal insulin in a single injection. As BIAsp 30 has been available internationally for 10 years, this review provides a comprehensive overview of the discovery of BIAsp 30, its pharmacokinetic and pharmacodynamic profile, safety and efficacy outcomes from the clinical trial programme, 'real-life' clinical insights provided by observational study data, and cost effectiveness and quality-of-life information. These studies have demonstrated that BIAsp 30 once or twice daily is an appropriate option for insulin initiation. BIAsp 30 also provides a switch option in patients on biphasic human insulin (BHI). Switching from BHI to BIAsp 30 is associated with improved postprandial glucose (PPG) and reduced nocturnal and major hypoglycaemia, although daytime hypoglycaemia is higher with BIAsp 30. Intensification of BIAsp 30 can be achieved by increasing the number of daily doses up to three times daily with meals. Therefore, BIAsp 30 provides an intensification option for individuals who are not achieving control with basal insulin and would prefer the simplicity of a single biphasic insulin instead of progressing to a basal-bolus approach. BIAsp 30 has a simple dose-titration algorithm, which enables patients to effectively self-titrate their insulin dose. Cost-effectiveness analyses have demonstrated that BIAsp 30 is cost effective or dominant compared with BHI 30 or insulin glargine in a number of healthcare settings. In conclusion, BIAsp 30 offers a simple and flexible option for insulin initiation and intensification that provides coverage of both fasting and prandial glucose. Adis © 2012 Springer International Publishing AG. All rights reserved. Source

Valensi P.,Paris Nord University | Lorgis L.,University Hospital | Cottin Y.,University Hospital
Archives of Cardiovascular Diseases | Year: 2011

The prevalence, incidence, risk factors and prognosis of silent myocardial infarction are less well known than those of silent myocardial ischaemia. The aims of this article are to evaluate the prevalence and incidence of silent myocardial infarction in subjects with or without a history of cardiovascular disease and in diabetic patients, and to identify potential risk factors and estimate prognosis through a review of the literature. A Medline search identified studies that provided data on the prevalence, incidence, potential risk factors and/or prognosis of silent myocardial infarction, among cohorts from the general population and large clinical studies of at-risk patients (with hypertension or a history of cardiovascular disease or diabetes). The search identified 15 studies in subjects from the general population, five in hypertensive patients, six in patients with a history of cardiovascular disease, and 10 in diabetic patients. The prevalence and incidence of silent myocardial infarction appear highly variable depending on the population studied, the patients' ages, and the method used to detect silent myocardial infarction. In the general population, the prevalence of silent myocardial infarction increased markedly with increasing age (up to > 5% in elderly subjects). Hypertension causes only a moderate increase in prevalence, whereas underlying cardiovascular diseases and diabetes are associated with marked increases in prevalence. The incidence of silent myocardial infarction changes in the same way. The main predictive factors of silent myocardial infarction are hypertension, history of cardiovascular diseases and diabetes duration. Silent myocardial infarction is associated with as poor a prognosis as clinical myocardial infarction. The frequency of silent myocardial infarction and the poor prognosis in at-risk patients amply justify its systematic early detection and active management. © 2011 Elsevier Masson SAS. All rights reserved. Source

Valensi P.,Paris Nord University | Shaban J.A.,Windsor Regional Hospital | Bushnell D.M.,Health Research Associates | Christensen T.L.,Novo Nordisk AS
Quality of Life Research | Year: 2010

Purpose: Understanding treatment satisfaction (TS) for diabetes is increasingly important as treatment options increase. This study examines treatment satisfaction with NovoMix® 30 in an observational study in patients with type 2 diabetes. Methods: The DiabMedSat assesses Overall, Treatment Burden, Symptom and Efficacy Treatment Satisfaction. The impact of type of pretreatment variables on TS was examined by ANOVA at baseline and week 26. Satisfaction at week 26 was examined by t-test and effect size. Linear regression models examined impact of prior treatment factors (age, gender, duration of diabetes, type of prior treatment and diabetes-related comorbidities) and current treatment factors (weight gain, hypoglycemic events, reaching therapeutic goal) on TS. Results: The data set comprised 17,488 persons. Prior treatment with insulin had a more positive impact on baseline satisfaction. At week 26, there were no differences between type of prior treatment groups in Overall, Symptoms and Burden TS. Current treatment with NovoMix 30 significantly improved TS. Regression analyses examining the combined effect of pretreatment factors and current treatment factors found that all factors except for age-impacted TS although the domains impacted varied. Conclusions: Patients treated with NovoMix 30 reported improved treatment satisfaction, and the improvement is considered clinically meaningful to patients. © 2010 The Author(s). Source

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