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La Rochelle, France

Heise T.,Profil Institute For Stoffwechselforschung | Tack C.J.,Radboud University Nijmegen | Cuddihy R.,International Diabetes Center | Davidson J.,University of Texas at Dallas | And 6 more authors.
Diabetes Care | Year: 2011

OBJECTIVE - Insulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of the novel basal analog insulin degludec (IDeg: 70%) and insulin aspart (IAsp: 30%). We compared the safety and efficacy of IDegAsp, an alternative formulation (AF) (55%IDeg and 45% IAsp), and insulin glargine (IGlar) in insulin-naïve subjects with type 2 diabetes inadequately controlled with oral antidiabetic drugs. RESEARCH DESIGN AND METHODS - In this 16-week, open-label trial, subjects (mean age 59.1 years, A1C 8.5%, BMI 30.3 kg/m 2) were randomized to once-daily IDegAsp (n = 59), AF (n = 59), or IGlar (n = 60), all in combination with metformin. Insulin was administered before the evening meal and dose-titrated to a fasting plasma glucose (FPG) target of 4.0-6.0 mmol/L. RESULTS - After 16 weeks, mean A1C decreased in all groups to comparable levels (IDegAsp: 7.0%; AF: 7.2%; IGlar: 7.1%). A similar proportion of subjects achieved A1C <7.0% without confirmed hypoglycemia in the last 4 weeks of treatment (IDegAsp: 51%; AF: 47%; IGlar: 50%). Mean 2-h postdinner plasma glucose increase was lower for IDegAsp (0.13 mmol/L) and AF (0.24mmol/L) than IGlar (1.63 mmol/L), whereasmean FPG was similar (IDegAsp: 6.8mmol/L; AF: 7.4 mmol/L; IGlar: 7.0 mmol/L). Hypoglycemia rates were lower for IDegAsp and IGlar than AF (1.2, 0.7, and 2.4 events/patient year). Nocturnal hypoglycemic events occurred rarely for IDegAsp (1 event) and IGlar (3 events) compared with AF (27 events). CONCLUSIONS - In this proof-of-concept trial, once-daily IDegAsp was safe, well tolerated, and provided comparable overall glycemic control to IGlar at similar low rates of hypoglycemia, but better postdinner plasma glucose control. © 2011 by the American Diabetes Association. Source


Kerlan V.,Brest University Hospital Center | Gouet D.,Center Hospitalier Of La Rochelle | Marre M.,Hopital Bichat | Renard T.,Montpellier University
Annales d'Endocrinologie | Year: 2013

Insulin degludec is a new basal insulin analogue with an ultra-long duration of action that provides a flat and stable action profile with a duration of action greater than 42hours. Two clinical trials comparing insulin degludec and insulin glargine in basal-bolus therapy have recently been published. Both were 52-week, multicentre, randomised (3:1), treat-to-target trials in patients already using insulin. In both type1 (n=629) and type2 diabetes (n=1006), insulin degludec was non-inferior to insulin glargine with respect to reduction in HbA1c at 52weeks. There were also no significant differences between treatment groups with respect to fasting plasma glucose. At similar levels of glycaemic control, however, insulin degludec was associated with lower rates of hypoglycaemia than insulin glargine. In type1 diabetes, overall confirmed hypoglycaemia (plasma glucose concentration<3.1mmol/L or severe episodes requiring assistance) was similar in the two treatment groups, but nocturnal confirmed hypoglycaemia (occurring from 00h01 to 05h59) was 25% lower with insulin degludec (P=0.021). In type 2diabetes, overall confirmed hypoglycaemia was 18% lower (P=0.0359) and nocturnal confirmed hypoglycaemia was 25% lower (P=0.0399) with insulin degludec. Reductions in hypoglycaemia could reduce physicians' and patients' fears and encourage them to titrate insulin more aggressively, and to adhere more closely to treatment, with consequent better glycaemic control. The results of these trials suggest that insulin degludec has a place in the French clinical setting in basal-bolus therapy in type1 and type2 diabetes. © 2013 Elsevier Masson SAS. Source


Cariou B.,Nantes University Hospital Center | Fontaine P.,University Hospital of Lille | Eschwege E.,French Institute of Health and Medical Research | Gouet D.,Center Hospitalier Of La Rochelle | And 3 more authors.
Diabetes and Metabolism | Year: 2015

Aim: DIALOG assessed the prevalence and predictors of hypoglycaemia in patients with type 1 (T1DM) or insulin-treated type 2 diabetes mellitus (T2DM) in a real-life setting. Methods: In this observational study, insulin-treated patients (n= 3048) completed prospective daily questionnaires reporting the frequency and consequences of severe/confirmed non-severe hypoglycaemia over 30 days. Patients (n= 3743) also retrospectively reported severe hypoglycaemia over the preceding year. Results: In this prospective survey, 85.3% and 43.6% of patients with T1DM and T2DM, respectively, reported experiencing at least one confirmed hypoglycaemic event over 30 days, while 13.4% and 6.4%, respectively, reported at least one severe event. Hypoglycaemia frequency increased with longer duration of diabetes and insulin therapy. Strongly predictive factors for hypoglycaemia were previous hypoglycaemia, >2 injections/day, BMI<30kg/m2 and duration of insulin therapy>10 years. HbA1c level was not predictive of hypoglycaemia in either T1DM or T2DM. The confirmed hypoglycaemia rate was increased in the lowest compared with the highest tertile of HbA1c in T1DM, but not T2DM. At the time of enrolment, physicians reported severe hypoglycaemia in 23.6% and 11.9% of T1DM and T2DM patients, respectively, during the preceding year; the retrospective survey yielded frequencies of 31.5% and 21.7%, respectively. Also, severe hypoglycaemia led to medical complications in 10.7% and 7.8% of events in T1DM and T2DM patients, respectively, over 30 days. Conclusion: Using a unique combined prospective and retrospective approach, the DIALOG study found a relatively high frequency of hypoglycaemia among insulin-treated patients. These findings emphasize the importance of a patient-centred approach for managing diabetes in which hypoglycaemia risk evaluation is critical. Trial registration: ClinicalTrials.gov: NCT01628341. © 2014 Elsevier Masson SAS. Source


Hawken C.,Roche Holding AG | Sarreau M.,Service Endocrinologie | Bernardin M.,Center Hospitalier Of La Rochelle | Delcourt A.-C.,Open Care Endocrinologist | And 4 more authors.
Annales d'Endocrinologie | Year: 2016

Graves' disease (GD) during pregnancy involves risks for the mother, foetus and neonate. Objective: To compile an inventory of the clinical practices regarding the management of GD during pregnancy in the Poitou-Charentes region of France. This was a retrospective, multicentre study covering the period 2005 to 2012. Ninety-five pregnancies were reviewed: 14 GD diagnosed during pregnancy, 24 GD already treated with synthetic antithyroid drugs (SAT) prior to pregnancy, 25 GD in remission before pregnancy and 32 GD who had undergone thyroidectomy prior to pregnancy. In patients under SAT and/or with TSH receptor antibody levels (TRAb). > 3. N at the 2nd (T2) and/or 3rd trimester (T3) of pregnancy, a foetal thyroid ultrasound (FTU) was performed in 18/32 cases and neonatal thyroid screening (NTS) in 14/20 cases. One case of foetal hyperthyroidism, two of neonatal hyperthyroidism and three of foetal hypothyroidism (including one neonatal hypothyroidism) were observed. Propylthiouracil was the preferred treatment prescribed, whatever the trimester. A congenital malformation was observed in 4/19 foetuses exposed to carbimazole during the 1st trimester (T1). In operated patients, TSH levels were. > 2.5. mIU/L during T1 in 23/32 cases, while TRAb were not assayed during pregnancy in 12/32 cases. The management of GD during pregnancy could be improved by adjusting SAT therapy during its course, titrating levothyroxine prior to conception and in early pregnancy in thyroidectomised patients, and a more targeted use of FTU during T2 and T3 and of neonatal thyroid screening. © 2016 Elsevier Masson SAS. Source


Sorel N.,University of Poitiers | Mayeur-Rousse C.,University of Poitiers | Deverriere S.,University of Poitiers | Roy L.,University of Poitiers | And 4 more authors.
Journal of Molecular Diagnostics | Year: 2010

We identified a novel breakpoint cluster region-ABL rearrangement in a chronic myeloid leukemia (CML) patient. The e14/a2 (b3/a2) type BCR-ABL mRNA incorporated a 42-nucleotide intronic insertion of ABL intron Ib between BCR exon e14 and ABL exon a2. As we hypothesized that the rearrangement between BCR and ABL genes occurred near the inserted sequence and because of the relative small size of BCR intron 14, we determined the BCR-ABL breakpoint at the genomic DNA level. Using a PCR-based method, this analysis revealed that i) BCR intron 14 brought a potential lariat branch point and the polypyrimidine tract, ii) the BCR-ABL breakpoint created a chimeric acceptor site, and iii) the inserted sequence of ABL intron Ib carried at its 3′ end a well-conserved donor splice site. Therefore, the inserted sequence was flanked by canonical consensus splice sites and recognized as a pseudo-exon (as shown by splice site prediction and exon finder software). Moreover, the insertion did not disrupt the reading frame between BCR and ABL and did not produce a premature stop codon. Instead, this novel BCR-ABL chimeric transcript encoded a functional oncoprotein with an in-frame insertion of 15 new amino acids. Copyright © American Society for Investigative Pathology and the Association for Molecular Pathology. Source

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