Initiation of biphasic insulin aspart 30/70 in subjects with type 2 diabetes mellitus in a largely primary care-based setting in Sweden.
ABSTRACT Despite a wealth of clinical trial data supporting use of the premixed insulin analogue, biphasic insulin aspart 30 (BIAsp 30) in the treatment of type 2 diabetes mellitus (T2DM), there is limited documentation of its use in primary care-based clinical practice.
An observational study investigating the safety and efficacy of BIAsp 30 in routine clinical practice was conducted. Patients were followed up 3 and 6 months after initiating insulin treatment. Safety and efficacy measures were documented.
During the course of the study, 1154 patients were included (age range 20-95 years), of whom 89% completed the 6-month follow-up period. Mean HbA(1c) at baseline was 8.8% (73mmol/mol), and had improved to 7.2% (55mmol/mol) after 6 months of treatment. The rate of total hypoglycaemia at completion of the study was 4.1 events per patient year. Major hypoglycaemic events were rare (two in total).
BIAsp 30 was initiated safely and effectively in insulin-naïve patients with T2DM. The safety and efficacy profile observed in clinical trials was confirmed in this largely primary care-based setting in Sweden.
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ABSTRACT: We aimed to identify predictors of hypoglycemia in patients with poorly controlled type-2 diabetes treated with a single daily bolus of insulin glulisine on top of insulin glargine and oral antidiabetic drugs (Basal-Plus regimen). We retrospectively analyzed four large Basal-Plus trials including 713 patients (47% female) with type-2 diabetes, mean age of 59.9±9.5 years and diabetes duration of 11±7.0 years. Predictors for symptomatic, severe, and nocturnal hypoglycemia were identified by multivariate logistic regression analyses, calculation of odds ratios, and Wald 95% confidence intervals. Mean numbers of hypoglycemic events/year were 4.64±11.4 (symptomatic <60 mg/dl), 0.59±2.28 (nocturnal) and 0.03±0.22 (severe). A total of 44.5% of patients reached the composite endpoint of HbA1c <7.0% plus no severe hypoglycemia, and 26.7% reached the composite of HbA1c <7.0% plus no symptomatic hypoglycemia. Predictors of nocturnal and symptomatic hypoglycemia were female gender (OR 1.82; 95%CI 1.07-3.11; OR 1.89; 95%CI 1.31-2.78), diabetes duration >10 versus <5 years (OR 2.61; 95%CI 1.03-6.59; OR 2.01; 95%CI 1.15-3.51), and higher basal insulin dose (per unit of increase) (OR 1.01; 95%CI 1.00-1.03; OR 1.01; 95%CI 1.00-1.02). Conversely, a higher BMI (27-30 vs. <27 kg/m(2) and >30 vs. <27 kg/m(2) ) conferred a reduced risk for symptomatic hypoglycemia with an OR of 0.53 (95%CI 0.31-0.90) and an OR of 0.61 (95%CI 0.39-0.97). Female gender, a long diabetes duration and higher basal insulin dose were predictors of hypoglycemia, while protection was provided by BMI > 30. These results may help to successfully establish basal-plus insulin regimen in individual patients on their transition from basal only to basal bolus treatment.Diabetes Obesity and Metabolism 08/2013; · 5.18 Impact Factor
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ABSTRACT: Aims: The choice of insulin at initiation in type 2 diabetes remains controversial. The aim of this study was to assess the occurrence of self-reported severe hypoglycaemia associated with premixed insulin analogues in routine clinical care. Methods: A 12-month, prospective, observational, multicentre study in patients starting a commonly prescribed premixed insulin analogue (either insulin lispro 25/75 or biphasic insulin aspart 30/70, twice daily) after suboptimal glycaemic control on oral antidiabetic agents. Treatment decisions were made solely in the course of usual practice. Results: Study follow-up was completed by 991 (85.5%) of the 1150 patients enrolled. At baseline, mean (SD) age was 57.9 (10.1) years; mean diabetes duration was 9.2 (5.9) years; mean haemoglobin A(1c) (HbA(1c) ) was 9.9 (1.8) % and the rate of severe hypoglycaemia was 0.03 episode/patient-year. At 12 months, the rate of severe hypoglycaemia was 0.04 episode/patient-year (95% CI 0.023, 0.055 episode/patient-year) and mean insulin dose was 41.5 (19.4) units. Changes from baseline to 12 months for mean fasting plasma glucose and HbA(1c) were -5.1 mmol/l and -2.5%, respectively. Conclusions: After initiation of premixed insulin analogues in patients with type 2 diabetes in real-world settings, the incidence of severe hypoglycaemia was lower than expected from previously reported studies.International Journal of Clinical Practice 11/2012; 66(11):1033-1041. · 2.54 Impact Factor
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ABSTRACT: It is uncertain whether the addition of biphasic insulin analogues to oral antidiabetic drugs (OADs) is as effective and safe as basal insulin in patients with type 2 diabetes mellitus (T2DM). We performed a systematic review to compare glycaemic control and selected clinical outcomes in T2DM patients inadequately controlled with OADs whose treatment was intensified by adding biphasic insulin aspart (BIAsp 30) or insulin glargine (IGlar). The analysis included randomised controlled trials (RCTs) identified by a systematic literature search in medical databases (MEDLINE, EMBASE, The Cochrane Library and other sources) up to March 2013. Studies met the inclusion criteria if they compared BIAsp 30 vs. IGlar added to at least one OAD in T2DM patients. Trials applying different OADs in both treatment arms were also included. Results were presented as weighted mean difference (WMD) or odds ratio (OR) with a 95% confidence interval (CI). Five trials, including a total number of 1758 patients followed up from 24 to 28 weeks, were identified. Quantitative synthesis demonstrated that BIAsp 30 reduced HbA1c level more efficiently than IGlar [5 RCTs; WMD (95% CI): -0.21% (-0.35%, -0.08%)]. Differences were observed in favour of BIAsp for lower mean prandial glucose increment [3 RCTs; WMD (95% CI): -14.70 mg/dl (-20.09, -9.31)]; no difference was observed for fasting plasma glucose [3 RCTs; WMD (95% CI): 7.09 mg/dl (-15.76, 29.94)]. We found no evidence for higher risk of overall [2 RCTs; 63% vs. 51%; OR = 1.77 (0.91; 3.44)] and severe hypoglycaemic episodes [4 RCTs; 0.98% vs. 1.12%; OR (95% CI) = 0.88 (0.31, 2.53)] in the BIAsp 30 group as compared with IGlar group. Twice-daily administration of BIAsp 30 resulted in larger weight gain [2 RCTs; WMD (95% CI) = 1.78 kg (1.04; 2.52)]. BIAsp 30 added to OAD therapy results in a better glycaemic control as compared with IGlar in T2DM patients. BIAsp 30 use is associated with slightly larger weight gain but no rise in risk of severe hypoglycaemic episodes.International Journal of Clinical Practice 01/2014; · 2.54 Impact Factor