Browsing by Subject "GLUCOSE CONTROL"

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  • Ritzel, Robert; Roussel, Ronan; Giaccari, Andrea; Vora, Jiten; Brulle-Wohlhueter, Claire; Yki-Järvinen, Hannele (2018)
    AimsTo investigate the efficacy and safety of insulin glargine 300U/mL (Gla-300) vs insulin glargine 100U/mL (Gla-100) over 12months in a patient-level meta-analysis, using data from the EDITION studies in people with type 2 diabetes (T2DM). Methods EDITION 1, 2 and 3 were multicentre, randomized, open-label, 2-arm, parallel-group, treat-to-target phase IIIa studies. Similar study designs and endpoints enabled a meta-analysis to be conducted. ResultsReductions in glycated haemoglobin (HbA1c) were better sustained over 12months with Gla-300 than with Gla-100 (least squares [LS] mean difference in change from baseline: -0.10 % [95% confidence interval {CI} -0.18 to -0.02] or -1.09mmol/mol [95% CI -2.01 to -0.20]; P=.0174). Risk of confirmed (3.9mmol/L) or severe hypoglycaemia was 15% lower with Gla-300 vs Gla-100 at night (relative risk 0.85 [95% CI 0.77-0.92]) and 6% lower at any time of day (relative risk 0.94 [95% CI 0.90-0.98]). Rates of hypoglycaemia were 18% lower with Gla-300 vs Gla-100 at night (rate ratio 0.82 [95% CI 0.67-0.99]), but comparable at any time of day. HbA1c ConclusionsIn a broad population of people with T2DM over 12months, use of Gla-300 provided more sustained glycaemic control and significantly lower hypoglycaemia risk at night and at any time of day compared with Gla-100.
  • Harris, Stewart B.; Parente, Erika B.; Karalliedde, Janaka (2022)
    Type 2 diabetes (T2D) is a progressive disease, with many individuals eventually requiring basal insulin therapy to maintain glycaemic control. However, there exists considerable therapeutic inertia to the prompt initiation and optimal titration of basal insulin therapy due to barriers that include fear of injections, hypoglycaemia, weight gain, and burdensome regimens. Hypoglycaemia is thought to be a major barrier to optimal glycaemic control and is associated with significant morbidity and mortality. Newer second-generation basal insulin analogues provide comparable glycaemic control with lower risk of hypoglycaemia compared with first-generation basal insulin analogues. The present review article discusses clinical evidence for one such second-generation basal insulin analogue, insulin glargine 300 U/mL (Gla-300), in the context of hypothetical case studies that are representative of individuals who may attend routine clinical practice. These case studies discuss individualised treatment needs for people with T2D who are insulin-naive or pre-treated. Clinical characteristics such as older age, frequent nocturnal hypoglycaemia, and renal impairment, which are known risk factors for hypoglycaemia, are also considered.
  • Riddle, Matthew C.; Bolli, Geremia B.; Home, Philip D.; Bergenstal, Richard M.; Ziemen, Monika; Muehlen-Bartmer, Isabel; Wardecki, Marek; Vinet, Laetitia; Jeandidier, Nathalie; Yki-Jarvinen, Hannele (2016)
    Background: Insulin glargine 300 U/mL (Gla-300) has a more constant and prolonged action profile than insulin glargine 100 U/mL and in clinical studies is associated with similar glycemic control but less hypoglycemia. Whether its effects are altered by variability of injection time was examined in two 3-month substudies. Materials and Methods: Eligible participants completing 6 months of optimized treatment with Gla-300 in EDITION 1 (n = 109) and EDITION 2 (n = 89), having a mean hemoglobin A1c (HbA(1c)) level of 7.3 % (SD 1.0 %), were randomized (1:1) to groups advised to increase variability of between-injection intervals to 24 +/- up to 3 h or to maintain fixed 24-h intervals for 3 months. Changes of HbA(1c) level and other efficacy and safety measures were assessed. Results: In the fixed-dosing group, 64% of participants reported all intervals within the 23-25-h range, compared with 15% of those advised flexible dosing. In the fixed- and flexible-dosing groups, 12% and 41%, respectively, of between-injection intervals were outside the 23-25-h range, and 2% and 16%, respectively, were outside the 21-27-h range. Least squares mean between-group difference in HbA(1c) change from baseline was 0.05 % (95% confidence interval [CI], -0.13 to 0.23); for fasting plasma glucose, 2.7 mg/dL (95% CI, -9.0 to 14.4); and for daily basal insulin dose, 0.00 U/kg (95% CI, -0.02 to 0.03). Frequencies of hypoglycemia and adverse events did not differ between groups. Conclusions: The efficacy and safety of Gla-300 demonstrated in EDITION 1 and EDITION 2 are maintained in substudies when the insulin was injected up to 3 h before or after the usual time of administration.
  • Riddle, M. C.; Yki-Järvinen, Hannele; Bolli, G. B.; Ziemen, M.; Muehlen-Bartmer, I.; Cissokho, S.; Home, P. D. (2015)
    AimsTo evaluate the maintenance of efficacy and safety of insulin glargine 300 U/ml (Gla-300) versus glargine 100 U/ml (Gla-100) in people with type 2 diabetes mellitus (T2DM) using basal plus meal-time insulin for 12 months in the EDITION 1 trial. MethodsEDITION 1 was a multicentre, randomized, open-label, two-arm, phase IIIa study. Participants completing the initial 6-month treatment period continued to receive Gla-300 or Gla-100, as previously randomized, once daily for a further 6-month open-label extension phase. Changes in glycated haemoglobin (HbA1c) and fasting plasma glucose concentrations, insulin dose, hypoglycaemic events and body weight were assessed. ResultsOf 807 participants enrolled in the initial phase, 89% (359/404) assigned to Gla-300 and 88% (355/403) assigned to Gla-100 completed 12 months. Glycaemic control was sustained in both groups (mean HbA1c: Gla-300, 7.24%; Gla-100, 7.42%), with more sustained HbA1c reduction for Gla-300 at 12 months: least squares mean difference Gla-300 vs Gla-100: HbA1c -0.17 [95% confidence interval (CI) -0.30 to -0.05]%. The mean daily basal insulin dose at 12 months was 1.03 U/kg for Gla-300 and 0.90 U/kg for Gla-100. Lower percentages of participants had 1 confirmed [3.9 mmol/l (70 mg/dl)] or severe hypoglycaemic event with Gla-300 than Gla-100 at any time of day [24 h; 86 vs 92%; relative risk 0.94 (95% CI 0.89-0.99)] and during the night [54 vs 65%; relative risk 0.84 (95% CI 0.75-0.94)], while the annualized rates of such hypoglycaemic events were similar. No between-treatment differences in adverse events were apparent. ConclusionDuring 12 months of treatment of T2DM requiring basal and meal-time insulin, glycaemic control was better sustained and fewer individuals reported hypoglycaemia with Gla-300 than with Gla-100. The mean basal insulin dose was higher with Gla-300 compared with Gla-100, but total numbers of hypoglycaemic events and overall tolerability did not differ between treatments.
  • Ritzel, R.; Roussel, R.; Bolli, G. B.; Vinet, L.; Brulle-Wohlhueter, C.; Glezer, S.; Yki-Järvinen, Hannele (2015)
    AimsTo conduct a patient-level meta-analysis of the EDITION 1, 2 and 3 studies, which compared the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with insulin glargine 100 U/ml (Gla-100) in people with type 2 diabetes (T2DM) on basal and mealtime insulin, basal insulin and oral antihyperglycaemic drugs, or no prior insulin, respectively. MethodsThe EDITION studies were multicentre, randomized, open-label, parallel-group, phase IIIa studies, with similar designs and endpoints. A patient-level meta-analysis of the studies enabled these endpoints to be examined over 6 months in a large population with T2DM (Gla-300, n = 1247; Gla-100, n = 1249). ResultsNo significant study-by-treatment interactions across studies were found, enabling them to be pooled. The mean change in glycated haemoglobin was comparable for Gla-300 and Gla-100 [each -1.02 (standard error 0.03)%; least squares (LS) mean difference 0.00 (95% confidence interval (CI) -0.08 to 0.07)%]. Annualized rates of confirmed (3.9 mmol/l) or severe hypoglycaemia were lower with Gla-300 than with Gla-100 during the night (31% difference in rate ratio over 6 months) and at any time (24 h, 14% difference). Consistent reductions were observed in percentage of participants with 1 hypoglycaemic event. Severe hypoglycaemia at any time (24 h) was rare (Gla-300: 2.3%; Gla-100: 2.6%). Weight gain was low ( ConclusionGla-300 provides comparable glycaemic control to Gla-100 in a large population with a broad clinical spectrum of T2DM, with consistently less hypoglycaemia at any time of day and less nocturnal hypoglycaemia.
  • Kauppila, Timo; Eriksson, Johan G.; Honkasalo, Mikko; Raina, Marko; Laine, Merja K. (2019)
    Aim: Previous study findings have shown that more frequent contacts with the diabetes care team predict better diabetes control. It is unknown whether this is true also for previous dropouts with type 2 diabetes (T2D). The aim of this study was to evaluate if those previous dropouts with T2D who succeeded to improve their glycaemic control had more frequent contacts with health care professionals in the public primary diabetes health care system than those dropouts who did not show improvement. Methods: In this "real life" retrospective cohort study, we identified 115 dropouts with T2D who were contacted by trained diabetes nurses and who returned to a public T2D-care system. Those previous dropouts who had baseline haemoglobin A(1c) >= 53 mmoVmol (7%) and had a reduction in HbA(1c) >= 6 mmol/mol (0.5%) during the follow-up were compared with those with unsatisfactory change in HbA(1c) (baseline HbA(1c) >= 53 mmoVmol and change Results: Previous dropouts showing improvement had more visits to the diabetes nurse (p = 0.003) and other nurses (p <0.001) than those with no improvement or those with satisfactory glycaemic control. Telephone calls not focusing on diabetes (p <0.001) were also more frequent among previous dropouts with improvement than among the others. Conclusions: Especially previous dropouts with T2D who had poor glycaemic control, may benefit from more frequent contacts including visits and telephone calls. Recalling dropouts does not seem to lead to overuse of the T2D care-system by those recalled patients whose glycaemic control does not require special care. (C) 2019 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.