Displaying publications 61 - 80 of 197 in total

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  1. Soewondo P, Mohamed M, Jain AB, Sy RA, Khoo CM
    Diabetes Res Clin Pract, 2013 Apr;100 Suppl 1:S10-6.
    PMID: 23647712 DOI: 10.1016/S0168-8227(13)70004-4
    AIM:
    To determine the safety and effectiveness of insulin detemir (IDet) in type 2 diabetes patients from the ASEAN cohort of the A1chieve study.

    METHODS:
    Patients from Indonesia, Malaysia, Philippines and Singapore prescribed IDet at the discretion of their physicians were included. The primary outcome was the incidence of serious adverse drug reactions including major hypoglycaemia over 24 weeks. Secondary endpoints included changes in the frequency of hypoglycaemia, serious adverse events and effectiveness assessments.

    RESULTS:
    This sub-analysis included 1540 patients (insulin-naive, 1239; insulin-experienced, 301) with mean age ± SD 56.4 ± 10.9 years, BMI 25.4 ± 4.6 kg/m(2) and diabetes duration 6.9 ± 5.3 years. Insulin-naive patients received a baseline IDet dose of 0.24 ± 0.11 U/kg titrated up to 0.37 ± 0.21 U/kg by Week 24. The pre-study insulin dose in insulin-experienced patients was 0.41 ± 0.25 U/kg and baseline IDet dose was 0.31 ± 0.24 U/kg titrated up to 0.40 ± 0.20 U/kg by Week 24. Overall hypoglycaemia decreased from 1.73 to 0.46 events/patient-year from baseline to Week 24 (change in proportion of patients affected, p < 0.0001). At Week 24, 1 major hypoglycaemic event was reported in 1 insulin-experienced patient. IDet significantly improved glucose control (p < 0.001) at Week 24. The lipid profile and systolic blood pressure improved (p < 0.001) and body weight did not change significantly. Quality of life was positively impacted (p < 0.001).

    CONCLUSION:
    IDet was well-tolerated and improved glycaemic control without increasing the risk of hypoglycaemia or weight gain.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  2. Sheu WH, Ji LN, Nitiyanant W, Baik SH, Yin D, Mavros P, et al.
    Diabetes Res Clin Pract, 2012 May;96(2):141-8.
    PMID: 22265956 DOI: 10.1016/j.diabres.2011.12.027
    AIMS: We examined the relationship of hypoglycemic symptoms with health-related quality of life and worry about hypoglycemia among type 2 diabetic patients using oral antihyperglycemic agents (AHA) in the Asia-Pacific region.
    METHODS: A total of 2257 type 2 diabetic patients with at least 6 months of oral AHA were enrolled in China, Korea, Malaysia, Thailand, and Taiwan. Quality of life was measured with the EuroQol Visual Analog Scale (EQ-VAS) and EuroQol-5 Dimensions questionnaire (EQ-5D), and worry about hypoglycemia with the worry subscale of the Hypoglycemic Fear Survey-II (HFS).
    RESULTS: The mean (SD) age was 58.7 (10.2) years and HbA(1c) was 7.5% (1.5). The proportion of patients with an HbA(1c) <6.5% and <7% was 24.9% and 41.8%, respectively. Hypoglycemic symptoms in the prior 6 months were reported by 35.8% of patients. Mean scores on the EQ-VAS and the EQ-5D were significantly lower for patients who had hypoglycemic symptoms compared to those who did not (73.6 vs. 76.9, p<0.001; 0.88 vs. 0.90, p<0.0001, respectively), whereas mean score on the HFS was significantly higher (12.5 vs. 6.3, p<0.001). In multivariate models, hypoglycemic symptoms were independently associated with scores on the EQ-5D, EQ-VAS, and HFS (all p ≤ 0.01-0.001). Symptom severity was positively associated with fear of hypoglycemia (all p ≤ 0.001).
    CONCLUSION: Hypoglycemic symptoms were associated with reduced quality of life and increased patient worry in patients with type 2 diabetes treated with AHA.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  3. Chan SP, Ji LN, Nitiyanant W, Baik SH, Sheu WH
    Diabetes Res Clin Pract, 2010 Aug;89(2):e30-2.
    PMID: 20541826 DOI: 10.1016/j.diabres.2010.05.008
    Symptoms of hypoglycemia were reported by 35.8% of patients with type 2 diabetes treated with oral antihyperglycemic agents in the Asia-Pacific region. Symptoms were severe in 11.6% and very severe in 8.2% of patients experiencing hypoglycemia.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  4. Al-Qazaz HKh, Hassali MA, Shafie AA, Sulaiman SA, Sundram S, Morisky DE
    Diabetes Res Clin Pract, 2010 Nov;90(2):216-21.
    PMID: 20832888 DOI: 10.1016/j.diabres.2010.08.012
    AIMS:
    To translate and examine the psychometric properties of the Malaysian version of the Morisky Medication Adherence Scale (MMAS) among patients with type 2 diabetes.

    METHODS:
    A standard "forward-backward" procedure was used to translate MMAS into Malay language. It was later validated on a convenience sample of 223 type 2 diabetes outpatients between May and September 2009. Reliability was tested for internal consistency. Validity was confirmed using convergent and known group validity.

    RESULTS:
    Employing the recommended scoring method, the mean±SD of MMAS scores was 6.13±1.72. Moderate internal consistency was found (Cronbach's α=0.675), the test-retest reliability value was 0.816 (p<0.001). A positive correlation between the eight- and four-item MMAS was found (r=0.792; p<0.01). A significant relationship between MMAS categories and HbA1c categories (χ(2)=20.261; p≥0.001) was found. The MMAS sensitivity and specificity, with positive and negative predictive values were 77.61%, 45.37%, 46.84% and 76.56%, respectively.

    CONCLUSIONS:
    The findings of this validation study indicate that the Malaysian version of the MMAS is a reliable and valid measure of medication adherence which can now be used.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  5. Chan SP, Colagiuri S
    Diabetes Res Clin Pract, 2015 Oct;110(1):75-81.
    PMID: 26361859 DOI: 10.1016/j.diabres.2015.07.002
    AIMS: Sulfonylureas are well positioned in treating type 2 diabetes, after lifestyle modification and metformin. The sulfonylurea gliclazide was given preference over glibenclamide in older people with type 2 diabetes in the World Health Organization model list of essential medicines. Consequently, a systematic review and meta-analysis of randomized controlled trials of the efficacy and safety of gliclazide versus other oral insulinotropic agents (sulfonylureas, dipeptidyl peptidase-4 inhibitors, and glinides) was performed.

    METHODS: Two reviewers searched MEDLINE for studies of ≥12 weeks duration in adults with type 2 diabetes. The key search word was "gliclazide", filtered with "randomized controlled trial", "human" and "19+ years". Differences were explored in mean change in glycated hemoglobin (HbA(1c)) from baseline (primary outcome) and risk of hypoglycemia (secondary outcome) between gliclazide and other oral insulinotropic agents; and other sulfonylureas.

    RESULTS: Nine out of 181 references reported primary outcomes, of which 7 reported secondary outcomes. Gliclazide lowered HbA1c more than other oral insulinotropic agents, with a weighted mean difference of -0.11% (95%, CI -0.19 to -0.03%, P=0.008, I(2)=60%), though not more than other sulfonylureas (-0.12%; 95%, CI -0.25 to 0.01%, P=0.07, I(2)=77%). Risk of hypoglycemia with gliclazide was not different to other insulinotropic agents (RR 0.85; 95%, CI 0.66 to 1.09, P=0.20, I(2)=61%) but significantly lower than other sulfonylureas (RR 0.47; 95%, CI 0.27 to 0.79, P=0.004, I(2)=0%).

    CONCLUSION: Compared with other oral insulinotropic agents, gliclazide significantly reduced HbA1c with no difference regarding hypoglycemia risk. Compared with other sulfonylureas, HbA1c reduction with gliclazide was not significantly different, but hypoglycemia risk was significantly lower.

    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  6. Mohd Yusof BN, Yahya NF, Hasbullah FY, Wan Zukiman WZHH, Azlan A, Yi RLX, et al.
    Diabetes Res Clin Pract, 2021 Feb;172:108530.
    PMID: 33157118 DOI: 10.1016/j.diabres.2020.108530
    AIMS: This narrative review aimed to synthesize the evidence on the effects of Ramadan-focused nutrition therapy for people with diabetes.

    METHODS: We searched MEDLINE (via PubMed) and Science Direct databases for articles that included the component of nutrition for adult patients with type 2 diabetes (T2D), published in English between 2010 and 2020.

    RESULTS: Fourteen studies met the criteria. Eight of 14 studies had an intervention with a control arm. In comparison to the control group, all studies (n = 8) showed a reduction in hypoglycemic events. However, only half of these studies (n = 4) had shown at least one positive clinical outcome. Features of nutrition therapy that appeared to have favorable clinical outcomes include individualized caloric prescription; distributing carbohydrates equally between Suhoor, Iftar and snacks; providing meal plans; adjusting food intake to suit Ramadan; and incorporating diabetes-specific formula as part of Suhoor or snack.

    CONCLUSIONS: The review provides evidence for the effectiveness of Ramadan-focused nutrition therapy among people with T2D and identifies key features of nutrition therapy that may provide favourable clinical outcomes. Additional data on dietary quality and adequacy during Ramadan fasting warrants further studies.

    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  7. Chew BH, Vos RC, Pouwer F, Rutten GEHM
    Diabetes Res Clin Pract, 2018 Aug;142:74-84.
    PMID: 29802952 DOI: 10.1016/j.diabres.2018.05.021
    AIMS: To examine whether diabetes distress (DD), when measured by three different instruments, was associated differently with self-efficacy, self-care activity, medication adherence and disease control in people with Type 2 diabetes mellitus.
    METHODS: A cross-sectional study in three health clinics. DD was assessed with the 17-item Diabetes Distress Scale, the 2-item DDS-2 (DDS-2) and the 5-item Problem Areas in Diabetes Scale (PAID-5). Dependent variables included self-efficacy, self-care activities, medication adherence, HbA1c, systolic and diastolic blood pressure (SBP, DBP). Multiple linear and logistic regression were used in analyses.
    RESULTS: In total 338 participants (56% women), with a mean age of 61 years and diabetes duration of 9.8 years, were included. DDS-2 was an independent determinant of SBP (β = 1.89, 95% CI 0.14, 3.64), DBP (β = 1.19, 95% CI 0.16, 2.21) and blood pressure target (OR = 2.09, 95% CI 1.12, 3.83). PAID-5 was an independent determinant of medication adherence (adjusted β = -0.05, 95% CI -0.08, -0.01) and self-care activities (OR = 0.50, 95% CI 0.26, 0.99).
    CONCLUSIONS: Associations of DD with important aspects of diabetes care are substantially influenced by confounders and depend on the way DD is measured. Our findings call for a judicious use of different DD measures in clinical practice and research. The study is registered on ClinicalTrials.gov (NCT02730754).
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy
  8. Colagiuri S, Matthews D, Leiter LA, Chan SP, Sesti G, Marre M
    Diabetes Res Clin Pract, 2018 Sep;143:1-14.
    PMID: 29802958 DOI: 10.1016/j.diabres.2018.05.028
    The sulfonylureas are effective oral glucose-lowering agents with a long history of clinical use. While all have the same general mechanism of action, their pharmacokinetic properties are influenced by factors such as dosage, rate of absorption, duration of action, route of elimination, tissue specificity, and binding affinity for pancreatic β-cell receptor. The result is a class of agents with similar HbA1c-lowering efficacy, but well-documented differences in terms of effects on hypoglycemia, and cardiovascular and renal safety. This review examines the differences between currently available sulfonylureas with a focus on how gliclazide modified release (MR) differs from other members of this class and from newer oral antihyperglycemic agents in the form of dipeptidyl peptidase-4 (DPP4) and sodium- glucose cotransporter 2 (SGLT2) inhibitors. The first part focuses on major outcome trials that have been conducted with the sulfonylureas and new oral agents. Consideration is then given to factors important for day-to-day prescribing including efficacy and durability, weight changes, hypoglycemia, renal effects and cost. Based on current evidence, third-generation sulfonylureas such as gliclazide MR possess many of the properties desired of a type 2 diabetes drug including high glucose-lowering efficacy, once-daily oral administration, few side effects other than mild hypoglycemia, and cardiovascular safety.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  9. Md Isa SH, Najihah I, Nazaimoon WM, Kamarudin NA, Umar NA, Mat NH, et al.
    Diabetes Res Clin Pract, 2006 Apr;72(1):48-52.
    PMID: 16253380 DOI: 10.1016/j.diabres.2005.09.011
    We studied the efficacy of four different treatment regimens (sulphonylurea and metformin+/-acarbose versus glimepiride and rosiglitazone versus glimepiride and bedtime NPH insulin versus multiple actrapid and NPH insulin injections) in poorly controlled type 2 diabetes subjects on hs-CRP, VCAM-1 and AGE at 4, 8 and 12 weeks of treatment. Multiple insulin injections rapidly improved HbA(1c) by 0.6+/-0.9% (p<0.005), 1.2+/-1.3% (p<0.0005) and 1.3+/-1.4% (p<0.0005) at week 4, at week 8 and week 12, respectively. Subjects who continued their existing combination treatment of sulphonylurea, metformin+/-acarbose also showed a significant reduction in HbA(1c) (p<0.05). Although effective in reducing glycemic parameters, there was no reduction in CRP levels in either treatment group. The treatment regimen consisting of rosiglitazone and glimepiride significantly lowered hs-CRP by -2.6 (3.9) mg/L (p<0.05) at week 12 in spite of no improvement in blood glucose. AGE improved in all groups irrespective of type of treatment, glycaemic control and CRP levels. Our data indicate rapid glycaemic control alone does not necessarily result in improvement in markers of inflammation in type 2 diabetes patients.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy
  10. Wan Mohamad WB, Tun Fizi A, Ismail RB, Mafauzy M
    Diabetes Res Clin Pract, 2000 Aug;49(2-3):93-9.
    PMID: 10963819 DOI: 10.1016/s0168-8227(00)00138-8
    Although long acting, glibenclamide is frequently given in split doses for type 2 diabetes mellitus. This may discourage compliance. It is thus appropriate to consider dosing it less frequently. We therefore studied glibenclamide effects when used once daily and when used in split doses. Our objective was to assess the feasibility of using once daily dosing as a regimen of choice. We measured plasma glucose, insulin, glibenclamide, lipids, HbAl and body mass index associated with the regimens. We also compared the number of hypoglycemic episodes occurring with them. Thirty type 2 diabetics on multiple daily glibenclamide were enrolled. Their regimens were changed over to once daily. Blood for glucose, insulin, lipids, HbAl and glibenclamide and body weight measurements were determined before and after the crossover period. We found no major difference in the sugar and insulin profiles with the two regimens. Fasting total cholesterol and triglyceride were also similar and so were plasma glibenclamide. The HbAl levels and body mass index and number of minor and major hypoglycemic episodes and hospital admissions for hypoglycemia also did not differ. We conclude that single daily dosing of glibenclamide was equivalent to multiple daily dose regimens. It can be used to an advantage to improve patient's compliance.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  11. Mafauzy M
    Diabetes Res Clin Pract, 2002 Oct;58(1):45-53.
    PMID: 12161056 DOI: 10.1016/s0168-8227(02)00104-3
    This study compared treatment with a prandial glucose regulator (repaglinide) and a sulphonylurea (glibenclamide) in Muslim Type 2 diabetic patients who practice Ramadan fasting. Two hundred and thirty-five patients, previously treated with a sulphonylurea, were randomised to receive either repaglinide (n=116, preprandially three-times daily) or glibenclamide (n=119, preprandially once- or twice-daily) 6 weeks before Ramadan. During Ramadan, patients changed their eating pattern to two meals daily, and the daily dose of repaglinide was redistributed to two preprandial doses. After Ramadan, patients resumed their regular meal pattern and treatment dosage for 4 weeks. During Ramadan, a statistically significant reduction in mean serum fructosamine concentration from baseline was observed in the repaglinide group (-16.9+/-4.9 micromol/l, -3.8%, P<0.05) but not the glibenclamide group (-6.9+/-4.8 micromol/l, -0.8%). Difference in change in HbA(1c) from baseline was not statistically significant between groups. The number of hypoglycaemic events with midday blood glucose <4.5 mmol/l was significantly lower in the repaglinide group (2.8%) than the glibenclamide group (7.9%) (P=0.001). Apart from hypoglycaemia, both treatments were equally well tolerated. Type 2 diabetic Muslims using prandial repaglinide showed a trend towards better glycaemic control and had a lower frequency of hypoglycaemia than patients using glibenclamide during Ramadan.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  12. Molugulu N, Yee LS, Ye YT, Khee TC, Nie LZ, Yee NJ, et al.
    Diabetes Res Clin Pract, 2017 Oct;132:157-168.
    PMID: 28797524 DOI: 10.1016/j.diabres.2017.07.025
    BACKGROUND: Type 2 Diabetes Mellitus (T2DM) is a chronic disorder and its treatment with only metformin often does not provide optimum glycemic control. Addition of sodium glucose cotransporter 2 inhibitor (SGLT2) will improve the glycemic control in patients on metformin alone. In this study, an attempt is made to investigate the combined therapy of SGLT-2 with metformin in managing T2DM in terms of lowering HbA1c and body weight and monotherapy using metformin alone in HbA1c and body weight reduction.

    OBJECTIVES: To compare the clinical effectiveness of combined therapy using SGLT2 inhibitor and metformin with monotherapy using metformin alone in HbA1c and body weight reduction.

    METHOD: A systematic review of the randomized controlled trials has been carried out and Cochrane risk of bias tool was used for the quality assessment. Patient, Intervention, Comparison and Outcomes (PICO) technique is used to select the relevant articles to meet the objective.

    RESULTS: The studies used in this article are multicenter, double-blinded randomized controlled trials on SGLT2 inhibitors with methformin, there were a total of 3897 participants, with a range of 182 to 1186 individual study size were included. Studies showed that combined therapy were more effective in HbA1c and body weight reduction as compared to monotherapy.

    CONCLUSION: The combined therapy of SGLT2 inhibitor along with metformin is more effective in HbA1c reduction and weight reduction as compared to monotherapy using metformin alone. Among the three SGLT2 inhibitors such as dapagliflozin canagliflozin and empagliflozin do not differ much in the efficiency of weight reduction. However, Empagliflozin 25mg is effective in HbA1c reduction.

    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  13. Scott EM, Bilous RW, Kautzky-Willer A
    Diabetes Technol Ther, 2018 03;20(3):180-188.
    PMID: 29470094 DOI: 10.1089/dia.2017.0386
    BACKGROUND: Accuracy of the FreeStyle Libre™ Flash Glucose Monitoring System has not been evaluated in pregnant women with diabetes. The aim of this study was to determine accuracy (compared to self-monitoring of blood glucose [SMBG]), clinical safety, and acceptability of the FreeStyle Libre System when used at home by this population.

    MATERIALS AND METHODS: Seventy-four participants, with type 1 (T1D, n = 24), type 2 (T2D, n = 11), or gestational (n = 39) diabetes, were enrolled across 13 sites (9 in United Kingdom, 4 in Austria). Average gestation was 26.6 ± 6.8 weeks (mean ± standard deviation), age was 30.5 ± 5.1 years, diabetes duration was 13.1 ± 7.3 years for T1D and 3.2 ± 2.5 years for T2D, and 49/74 (66.2%) used insulin to manage their diabetes. Sensors were worn for up to 14 days. Sensor glucose values (masked) were compared with capillary SMBG values (made at least 4 times/day).

    RESULTS: Clinical accuracy of sensor results versus SMBG results was demonstrated, with 88.1% and 99.8% of results within Zone A and Zones A and B of the Consensus Error Grid, respectively. Overall mean absolute relative difference was 11.8%. Sensor accuracy was unaffected by the type of diabetes, the stage of pregnancy, whether insulin was used, age or body mass index. User questionnaires indicated high levels of satisfaction with sensor wear, system use, and comparison to SMBG. There were no unanticipated device-related adverse events.

    CONCLUSIONS: Good agreement was demonstrated between the FreeStyle Libre System and SMBG. Accuracy of the system was unaffected by patient characteristics, indicating that the system is safe and accurate to use by pregnant women with diabetes.

    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy
  14. Rama Chandran S, A Vigersky R, Thomas A, Lim LL, Ratnasingam J, Tan A, et al.
    Diabetes Technol Ther, 2020 02;22(2):103-111.
    PMID: 31502876 DOI: 10.1089/dia.2019.0277
    Background:
    Complex changes of glycemia that occur in diabetes are not fully captured by any single measure. The Comprehensive Glucose Pentagon (CGP) measures multiple aspects of glycemia to generate the prognostic glycemic risk (PGR), which constitutes the relative risk of hypoglycemia combined with long-term complications. We compare the components of CGP and PGR across type 1 and type 2 diabetes.
    Methods:
    Participants: n = 60 type 1 and n = 100 type 2 who underwent continuous glucose monitoring (CGM). Mean glucose, coefficient of variation (%CV), intensity of hypoglycemia (INThypo), intensity of hyperglycemia (INThyper), time out-of-range (TOR <3.9 and >10 mmol/L), and PGR were calculated. PGR (median, interquartile ranges [IQR]) for diabetes types, and HbA1c classes were compared.
    Results:
    While HbA1c was lower in type 1 (type 1 vs. type 2: 8.0 ± 1.6 vs. 8.6 ± 1.7, P = 0.02), CGM-derived mean glucoses were similar across both groups (P > 0.05). TOR, %CV, INThypo, and INThyper were all higher in type 1 [type 1 vs. type 2: 665 (500, 863) vs. 535 (284, 823) min/day; 39% (33, 46) vs. 29% (24, 34); 905 (205, 2951) vs. 18 (0, 349) mg/dL × min2; 42,906 (23,482, 82,120) vs. 30,166 (10,276, 57,183) mg/dL × min2, respectively, all P type 1. While mean glucose remained the same across HbA1c classes, %CV, TOR, INThyper, and INThypo were significantly higher for type 1. Even within the same HbA1c class, the variation (IQR) of each parameter in type 1 was wider. The PGR increased across diabetes groups; type 2 on orals versus type 2 on insulin versus type 1 (PGR: 1.6 vs. 2.2 vs. 2.9, respectively, P 
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy
  15. Ji L, Han P, Liu Y, Yang G, Dieu Van NK, Vijapurkar U, et al.
    Diabetes Obes Metab, 2015 Jan;17(1):23-31.
    PMID: 25175734 DOI: 10.1111/dom.12385
    To evaluate the efficacy and safety of canagliflozin, a sodium glucose co-transporter 2 inhibitor, in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by metformin or metformin in combination with sulphonylurea.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  16. 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: Diabetes Mellitus, Type 2/drug therapy*
  17. Ji L, Li L, Kuang J, Yang T, Kim DJ, Kadir AA, et al.
    Diabetes Obes Metab, 2017 05;19(5):754-758.
    PMID: 28075066 DOI: 10.1111/dom.12875
    This study evaluated the efficacy and safety of 26 weeks of twice-daily (BID) alogliptin + metformin fixed-dose combination (FDC) therapy in Asian patients with type 2 diabetes. Patients aged 18 to 75 years with hemoglobin A1c (HbA1c) of 7.5% to 10.0% after ≥2 months of diet and exercise and a 4-week placebo run-in were enrolled. Eligible patients were randomized (1:1:1:1) to placebo, alogliptin 12.5 mg BID, metformin 500 mg BID or alogliptin 12.5 mg plus metformin 500 mg FDC BID. The primary endpoint was change in HbA1c from baseline to end of treatment (Week 26). In total, 647 patients were randomized. The least-squares mean change in HbA1c from baseline to Week 26 was -0.19% with placebo, -0.86% with alogliptin, -1.04% with metformin and -1.53% with alogliptin + metformin FDC. Alogliptin + metformin FDC was significantly more effective ( P  type 2 diabetes.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  18. Wan Seman WJ, Kori N, Rajoo S, Othman H, Mohd Noor N, Wahab NA, et al.
    Diabetes Obes Metab, 2016 06;18(6):628-32.
    PMID: 26889911 DOI: 10.1111/dom.12649
    The aim of the present study was to assess the hypoglycaemia risk and safety of dapagliflozin compared with sulphonylurea during the fasting month of Ramadan. In this 12-week, randomized, open-label, two-arm parallel group study, 110 patients with type 2 diabetes who were receiving sulphonylurea and metformin were randomized either to receive 10 mg (n = 58) of dapagliflozin daily or to continue receiving sulphonylurea (n = 52). The primary outcome was to compare the effects of dapagliflozin and sulphonylurea on the proportions of patients with at least one episode of hypoglycaemia during Ramadan, as well as to assess the safety of dapagliflozin when used to treat patients observing Ramadan. A lower proportion of patients had reported or documented hypoglycaemia in the dapagliflozin group than in the sulphonylurea group: 4 (6.9%) versus 15 (28.8%); p = 0.002. The relative risk of any reported or documented hypoglycaemia in the 4th week of Ramadan was significantly lower in the dapagliflozin group: RR=0.24, 95%CI: 0.09, 0.68; p=0.002. No significance differences were observed between the two groups regarding postural hypotension (13.8 vs 3.8%; p = 0.210) or urinary tract infections (10.3 vs 3.8%; p = 0.277). In conclusion, fewer patients exhibited hypoglycaemia in the dapagliflozin group than in the sulphonylurea group.
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  19. Azar ST, Echtay A, Wan Bebakar WM, Al Araj S, Berrah A, Omar M, et al.
    Diabetes Obes Metab, 2016 10;18(10):1025-33.
    PMID: 27376711 DOI: 10.1111/dom.12733
    AIMS: Compare effects of liraglutide 1.8 mg and sulphonylurea, both combined with metformin, on glycaemic control in patients with type 2 diabetes (T2D) fasting during Ramadan.

    MATERIALS AND METHODS: In this up to 33-week, open-label, active-controlled, parallel-group trial, adults [glycated haemoglobin (HbA1c) 7%-10% (53-86 mmol/mol); body mass index ≥20 kg/m(2) ; intent to fast] were randomized (1:1) ≥10 weeks before Ramadan to either switch to once-daily liraglutide (final dose 1.8 mg) or continue pre-trial sulphonylurea at maximum tolerated dose, both with metformin.

    PRIMARY ENDPOINT: change in fructosamine, a validated marker of short-term glycaemic control, during Ramadan.

    RESULTS: Similar reductions in fructosamine levels were observed for both groups during Ramadan [liraglutide (-12.8 µmol/L); sulphonylurea (-16.4 µmol/L); estimated treatment difference (ETD) 3.51 µmol/L (95% CI: -5.26; 12.28); p = 0.43], despite lower fructosamine levels in the liraglutide group at start of Ramadan. Fewer documented symptomatic hypoglycaemic episodes were reported in liraglutide-treated (2%, three subjects) versus sulphonylurea-treated patients (11%, 18 subjects). No severe hypoglycaemic episodes were reported by either group. Body weight decreased more during Ramadan with liraglutide (ETD: -0.54 kg; 95% CI: -0.94;-0.14; p = 0.0091). The proportion of patients reporting adverse events was similar between groups. Liraglutide led to greater HbA1c reduction [ETD: -0.59% (-6.40 mmol/mol), 95% CI: -0.79; -0.38%; -8.63; -4.17 mmol/mol; p 

    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
  20. Yu Pan C, Han P, Liu X, Yan S, Feng P, Zhou Z, et al.
    Diabetes Metab Res Rev, 2014 Nov;30(8):726-35.
    PMID: 24639432 DOI: 10.1002/dmrr.2541
    BACKGROUND: This study assessed the efficacy and safety of the once-daily glucagon-like peptide-1 receptor agonist, lixisenatide, in Asian patients with type 2 diabetes mellitus inadequately controlled on metformin ± sulfonylurea.
    METHODS: In this 24-week, double-blind, placebo-controlled, multinational study, patients were randomized to lixisenatide 20 µg once daily or placebo. The primary endpoint was absolute change in glycated haemoglobin (HbA1c ) from baseline to week 24.
    RESULTS: A total of 391 patients were randomized. Lixisenatide significantly reduced HbA1c levels compared with placebo (LS mean difference: -0.36%, p = 0.0004). A significantly higher proportion of lixisenatide-treated patients achieved HbA1c targets of <7% (p = 0.003) and ≤6.5% (p = 0.001) versus placebo. Lixisenatide was associated with a statistically significant reduction in 2-h postprandial plasma glucose after a standardized breakfast versus placebo (LS mean difference: -4.28 mmol/L, p type 2 diabetes mellitus insufficiently controlled on metformin ± sulfonylurea, lixisenatide significantly improved glycaemic control and was well tolerated during the 24-week study.
    TRIAL REGISTRATION: ClinicalTrials.gov NCT01169779.
    KEYWORDS: Asia; glucagon-like peptide-1 (GLP-1) receptor agonists; lixisenatide; type 2 diabetes mellitus (T2DM)
    Matched MeSH terms: Diabetes Mellitus, Type 2/drug therapy*
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