Displaying all 6 publications

Abstract:
Sort:
  1. Hussein Z, Aziz NA, Dhanaraj E, Brahmachari B, Kothekar M
    Med J Malaysia, 2020 07;75(4):372-378.
    PMID: 32723997
    INTRODUCTION: Biosimilar insulins have the potential to increase access to treatment among patients with diabetes mellitus (DM), reduce treatment costs, and expand market competition. There are no published studies evaluating the performance of biosimilar insulins in routine clinical practice in Asia. This study assessed the safety and effectiveness of biphasic isophane insulin injection in Malaysian DM patients.

    MATERIALS AND METHODS: In this open label, single-arm, observational, post marketing study, patients received biphasic isophane insulin injection as per the Prescribing Information; and were assessed for safety (adverse events including hypoglycaemia), effectiveness (glycosylated haemoglobin [HbA1c]; fasting blood sugar, [FBS]; and patient's condition by patient and physician) over a period of 24 weeks.

    RESULTS: Adult male and female diabetes patients (N=119; type 2 DM, n=117) with a mean (SD) diabetes duration of 13 years were included. No new safety signals have been identified. Significant reduction in HbA1c was observed at weeks 12 and 24 (mean [SD] - baseline: 9.6% [1.9]; Week 12: 9.0% [1.7] and at Week 24: 9.1% [1.7]; p < 0.001). There were 10 serious and 9 non-serious adverse events reported in the study. Expected mild events included hypoglycaemia and injection site pruritus. However, the majority of the adverse events were non-study drug related events. No deaths were reported during the study.

    DISCUSSION: Biphasic isophane insulin injection was well tolerated with no new safety concerns. It was found effective in post- marketing studies conducted in routine clinical settings when administered in DM patients in this study.

    Matched MeSH terms: Biphasic Insulins/adverse effects*; Biphasic Insulins/therapeutic use*
  2. Hassanein M, Echtay AS, Malek R, Omar M, Shaikh SS, Ekelund M, et al.
    Diabetes Res Clin Pract, 2018 Jan;135:218-226.
    PMID: 29183844 DOI: 10.1016/j.diabres.2017.11.027
    AIMS: To compare the efficacy and safety of insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) before, during and after Ramadan in patients with type 2 diabetes mellitus (T2DM) who fasted during Ramadan.

    METHODS: In this multinational, randomised, treat-to-target trial, patients with T2DM who intended to fast and were on basal, pre- or self-mixed insulin ± oral antidiabetic drugs for ≥90 days were randomised (1:1) to IDegAsp twice daily (BID) or BIAsp 30 BID. Treatment period included pre-Ramadan treatment initiation (with insulin titration for 8-20 weeks), Ramadan (4 weeks) and post-Ramadan (4 weeks). Insulin doses were reduced by 30-50% for the pre-dawn meal (suhur) on the first day of Ramadan, and readjusted to the pre-Ramadan levels at the end of Ramadan. Hypoglycaemia was analysed as overall (severe or plasma glucose <3.1 mmol/L [56 mg/dL]), nocturnal (00:01-05:59) or severe (requiring assistance of another person).

    RESULTS: During the treatment period, IDegAsp (n = 131) had significantly lower overall and nocturnal hypoglycaemia rates with similar glycaemic efficacy, versus BIAsp 30 (n = 132). During Ramadan, despite achieving significantly lower pre-iftar (meal at sunset) self-measured plasma glucose (estimated treatment difference: -0.54 mmol/L [-1.02; -0.07]95% CI, p = .0247; post hoc) with similar overall glycaemic efficacy, IDegAsp showed significantly lower overall and nocturnal hypoglycaemia rates versus BIAsp 30.

    CONCLUSIONS: IDegAsp is a suitable therapeutic agent for patients who need insulin for sustained glucose control before, during and after Ramadan fasting, with a significantly lower risk of hypoglycaemia, versus BIAsp 30, an existing premixed insulin analogue.

    Matched MeSH terms: Biphasic Insulins
  3. Shafie AA, Gupta V, Baabbad R, Hammerby E, Home P
    Diabetes Res Clin Pract, 2014 Nov;106(2):319-27.
    PMID: 25305133 DOI: 10.1016/j.diabres.2014.08.024
    Aim: This study aimed to assess the cost-effectiveness of starting insulin therapy with biphasic insulin aspart 30 (BIAsp 30) in people with type 2 diabetes inadequately controlled on oral glucose-lowering drugs in Saudi Arabia, India, Indonesia, and Algeria.

    Methods: The IMS CORE Diabetes Model was used to evaluate economic outcomes associated with starting BIAsp 30, using baseline characteristics and treatment outcomes from the A(1)chieve study. Time horizons of 1 and 30 years were applied, with country-specific costs for complications, therapies, and background mortality. Incremental cost-effectiveness ratios (ICERs) are expressed as cost per quality-adjusted life-year (QALY) in local currencies, USD, and fractions of local GDP per capita (GDPc). Cost-effectiveness was pre-defined using the World Health Organization definition of <3.0 times GDPc. Comprehensive sensitivity analyses were performed.

    Results: In the primary 30-year analyses, starting BIAsp 30 was associated with a projected increase in life expectancy of >1 year and was highly cost-effective, with ICERs of -0.03 (Saudi Arabia), 0.25 (India), 0.48 (India), 0.47 (Indonesia), and 0.46 (Algeria) GDPc/QALY. The relative risk of developing selected complications was reduced in all countries. Sensitivity analyses including cost of self-monitoring, treatment costs, and deterioration of glucose control with time showed the results to be robust. In a 1-year analysis, ICER per QALY gained was still cost-effective or highly cost-effective.

    Conclusion: Starting BIAsp 30 in people with type 2 diabetes in the A(1)chieve study was found to be cost-effective across all country settings at 1- and 30-year time horizons, and usefully increased predicted life expectancy.

    Keywords: A(1)chieve; Biphasic insulin aspart 30; Cost-effectiveness; Type 2 diabetes mellitus.
    Matched MeSH terms: Biphasic Insulins/economics*; Biphasic Insulins/therapeutic use
  4. Bebakar WM, Chow CC, Kadir KA, Suwanwalaikorn S, Vaz JA, Bech OM, et al.
    Diabetes Obes Metab, 2007 Sep;9(5):724-32.
    PMID: 17593237 DOI: 10.1111/j.1463-1326.2007.00743.x
    Aim: To evaluate the efficacy and safety of adding biphasic insulin aspart 30 (BIAsp30; NovoMix 30) to existing oral antidiabetic agents (OADs) vs. optimizing OADs in a subgroup of Western Pacific patients with type 2 diabetes inadequately controlled on oral monotherapy or oral combination therapy.

    Methods: This 26-week, multi-centre, open-labelled, randomized, two-arm parallel trial consisted of a 2-week screening period, followed by 24 weeks of treatment. Subjects randomized to BIAsp30 treatment (n = 129) received BIAsp30 once daily (o.d.) at dinnertime between Week 2 and Week 14, and those not reaching treatment targets were switched to twice daily (b.i.d.) BIAsp30 at Week 14 (n = 50). Subjects randomized to the OAD-only arm (n = 63) continued with their previous OAD treatment and, in an attempt to reach treatment goals, the dose was optimized (but OAD unchanged) in accordance to local treatment practice and labelling.

    Results: Significantly greater reductions in HbA(1c) over Weeks 0-13 with BIAsp30 (o.d.) vs. OAD-only treatment (1.16 vs. 0.58%; p < 0.001), and over Weeks 0-26, with BIAsp30 (o.d.) and BIAsp30 (b.i.d.) treatments vs. OAD-only treatment (1.24 vs. 1.34 vs. 0.67%; p < 0.01). Hypoglycaemic episodes were reported in 54% of the patients in BIAsp30 (o.d. and b.i.d. pooled) and 30% of the patients in OAD-only group. All episodes were minor or symptomatic, except for one in each treatment group, which was major.

    Conclusions: Initiating BIAsp30 treatment is a safe and more effective way to improve glycaemic control in Western Pacific patients with type 2 diabetes inadequately controlled with oral monotherapy or oral combination therapy compared with optimizing oral combination therapy alone. In patients not reaching treatment target on BIAsp30 (o.d.), treatment with BIAsp30 (b.i.d.) should be considered.
    Matched MeSH terms: Biphasic Insulins
  5. Lim-Abrahan MA, Jain AB, Bebakar WM, Seah D, Soewondo P
    Diabetes Res Clin Pract, 2013 Apr;100 Suppl 1:S3-9.
    PMID: 23647715 DOI: 10.1016/S0168-8227(13)70003-2
    AIM:
    To determine the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in the ASEAN cohort of the A₁chieve study.

    METHODS:
    Type 2 diabetes patients from Indonesia, Malaysia, Philippines and Singapore prescribed BIAsp 30 therapy were included. The primary outcome was evaluation of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary outcomes were changes in hypoglycaemic events, serious adverse events (SAEs) and effectiveness parameters.

    RESULTS:
    This sub-analysis included 2798 patients (insulin-naive, 1903; insulin-experienced, 895) with mean age ± SD, 55.3 ± 10.8 years, BMI, 24.9 ± 4.6 kg/m(2) and diabetes duration, 7.5 ± 5.9 years. Baseline HbA1c in the entire cohort was poor (9.9%, 85 mmol/mol). A total of 15 SAEs were reported in 7 insulin-experienced patients (1 moderate event was related to BIAsp 30). Overall hypoglycaemia at Week 24 was 0.88 events/patient-year compared to 1.71 events/patient-year reported at baseline (change in proportion of patients affected, p < 0.0001). No major hypoglycaemia was reported at Week 24. BIAsp 30 significantly improved glucose control (HbA1c, fasting plasma glucose and postprandial plasma glucose, p < 0.001) at Week 24. The proportion of patients achieving HbA1c <7.0% at Week 24 was 35.3% compared to 3.5% at baseline. The lipid profile and systolic blood pressure also improved significantly (p < 0.001). Quality of life was positively impacted (mean change in visual analogue scores from EQ-5D = 10.6 ± 13.8 points, p < 0.001).

    CONCLUSION:
    BIAsp 30 was well-tolerated and improved glucose control while decreasing the risk of hypoglycaemia.
    Matched MeSH terms: Biphasic Insulins/adverse effects; Biphasic Insulins/therapeutic use*
  6. Hussein Z, Lim-Abrahan MA, Jain AB, Goh SY, Soewondo P
    Diabetes Res Clin Pract, 2013 Apr;100 Suppl 1:S24-9.
    PMID: 23647714 DOI: 10.1016/S0168-8227(13)70006-8
    Aim: To evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in ASEAN type 2 diabetes (T2D) patients switched from biphasic human insulin (BHI) in the non-interventional 24-week A₁chieve study.

    Methods: Indonesian, Malaysian, Filipino and Singaporean patients switched from BHI to BIAsp 30 at their physicians' discretion were included. The incidence of serious adverse drug reactions (SADRs), including major hypoglycaemia was the primary endpoint. Changes in hypoglycaemia, glycated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG), postprandial plasma glucose (PPPG), lipids, body weight and systolic blood pressure were also evaluated. Quality of life (QoL) was measured using the EQ-5D questionnaire.

    Results: For the 465 patients included (mean ± SD age: 56 ± 10.3 years, diabetes duration: 9.7 ± 7.1 years, baseline HbA1c: 9.4 ± 1.8%), the mean pre-study BHI dose was 0.62 ± 0.28 IU/kg and 63.4% were dosing BHI twice daily (bid). The mean baseline BIAsp 30 dose was 0.65 ± 0.27 U/kg, titrated up to 0.71 ± 0.28 U/kg over 24 weeks, and most patients continued bid dosing. No SADRs or major hypoglycaemic episodes were reported. The proportion of patients reporting overall hypoglycaemia decreased significantly from 10.8% at baseline to 3.4% at Week 24 (p < 0.0001). Significant improvements in glycaemic control were noted (HbA1c: -1.4 ± 1.7%, FPG: -56.7 ± 72.5 mg/dL, post-breakfast PPPG: -84.8 ± 82.8 mg/dL, p < 0.001). Mean QoL improved by +6.6 ± 14.6 points (p < 0.001).

    Conclusion: BIAsp 30 was well-tolerated and significantly increased glycaemic control in this ASEAN subgroup poorly controlled on BHI.
    Matched MeSH terms: Biphasic Insulins/adverse effects; Biphasic Insulins/therapeutic use*
Filters
Contact Us

Please provide feedback to Administrator (afdal@afpm.org.my)

External Links