Displaying publications 1 - 20 of 42 in total

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  1. Zaman Huri H, Chai Ling L
    BMC Public Health, 2013;13:1192.
    PMID: 24341672 DOI: 10.1186/1471-2458-13-1192
    Drug-Related Problems (DRPs) commonly occur among type 2 diabetes mellitus (T2DM) patients. However, few studies have been performed on T2DM patients with dyslipidemia. This purpose of this study was to assess drug-related problems (DRPs) and factors associated with its occurrence.
    Matched MeSH terms: Hypoglycemic Agents/adverse effects*
  2. Leong XY, Thanikachalam PV, Pandey M, Ramamurthy S
    Biomed Pharmacother, 2016 Dec;84:1051-1060.
    PMID: 27780133 DOI: 10.1016/j.biopha.2016.10.044
    BACKGROUND: Swertiamarin, is a secoiridoid glycoside found in genera of Enicostemma Species (Enicostemma littorale and Enicostemma axillare) belonging to the family of gentianaceae, which has been reported to cure many diseases such as diabetes, hypertension, atherosclerosis, arthritis, malaria and abdominal ulcers. However, to the best of our knowledge, till date systematic studies to understand the molecular basis of cardiac and metabolic disease preventing properties of swertiamarin has not been reported.

    AIM OF THE REVIEW: The present review aims to compile an up-to-date information on the progress made in the protective role of swertiamarin in cardiac and metabolic diseases with the objective of providing a guide for future research on this bioactive molecule.

    MATERIALS AND METHODS: Information on the swertiamarin was collected from major scientific databases (Pubmed, Springer, google scholar, and Web of Science) for publication between1974-2016. In this review, the protective role of swertiamarin on cardiac and metabolic diseases was discussed.

    RESULTS: Swertiamarin reported to exhibit a wide range of biological activities such as anti-atherosclerotic, antidiabetic, anti-inflammatory and antioxidant effects. These activities were mainly due to its effect on various signaling pathways associated with cardiac remodeling events such as inhibition of NF-kB expression, LDL oxidation, apoptosis, inflammatory and lipid peroxidation markers and stimulation of antioxidant enzymes.

    CONCLUSION: Sweriamarin exhibit a wide range of biological activities. This review presents evidence supporting the point of view that swertiamarin should be considered a potential therapeutic agent against cardiac and metabolic diseases, giving rise to novel applications in their prevention and treatment.

    Matched MeSH terms: Hypoglycemic Agents/adverse effects
  3. Ajiboye BO, Dada S, Fatoba HO, Lawal OE, Oyeniran OH, Adetuyi OY, et al.
    Biomed Pharmacother, 2023 Dec;168:115681.
    PMID: 37837880 DOI: 10.1016/j.biopha.2023.115681
    This experiment was conducted to evaluate the Dalbergiella welwitschia alkaloid-rich extracts on liver damage in streptozotocin-induced diabetic rats. Hence, to induce diabetes, 45 mg/kg body weight of streptozotocin was intraperitoneally injected into the Wistar rats. Subsequently, 5 % (w/v) of glucose water was given to the induced animals for 24 h. Thus, the animals (48) were grouped into five groups (n = 8), containing normal control (NC), diabetic control (DC), diabetic rats placed on low (50 mg/kg body weight) and high (100 mg/kg body weight) doses of D. welwitschi alkaloid-rich leaf extracts (i.e. DWL and DWH respectively), and diabetic rats administered 200 mg/kg body weight of metformin (MET). The animals were sacrificed on the 21st day of the experiment, blood and liver were harvested, and different liver damage biomarkers were evaluated. The results obtained demonstrated that diabetic rats administered DWL, DWH and MET significantly (p  0.05) different when compared with NC. Also, diabetic rats administered DWL, DWH and MET revealed a significant (p  0.05) different when compared with NC. In addition, histological examination revealed that diabetic rats placed on DWL, DWH and MET normalized the hepatocytes. Consequently, it can be inferred that alkaloid-rich extracts from D. welwitschi leaf could be helpful in improving liver damage associated with diabetes mellitus rats.
    Matched MeSH terms: Hypoglycemic Agents/adverse effects
  4. Borgquist S, Rosendahl AH, Czene K, Bhoo-Pathy N, Dorkhan M, Hall P, et al.
    Breast Cancer Res, 2018 08 09;20(1):93.
    PMID: 30092829 DOI: 10.1186/s13058-018-1026-7
    BACKGROUND: Long-term insulin exposure has been implicated in breast cancer etiology, but epidemiological evidence remains inconclusive. The aims of this study were to investigate the association of insulin therapy with mammographic density (MD) as an intermediate phenotype for breast cancer and to assess associations with long-term elevated circulating insulin levels using a genetic score comprising 18 insulin-associated variants.

    METHODS: We used data from the KARolinska MAmmography (Karma) project, a Swedish mammography screening cohort. Insulin-treated patients with type 1 (T1D, n = 122) and type 2 (T2D, n = 237) diabetes were identified through linkage with the Prescribed Drug Register and age-matched to 1771 women without diabetes. We assessed associations with treatment duration and insulin glargine use, and we further examined MD differences using non-insulin-treated T2D patients as an active comparator. MD was measured using a fully automated volumetric method, and analyses were adjusted for multiple potential confounders. Associations with the insulin genetic score were assessed in 9437 study participants without diabetes.

    RESULTS: Compared with age-matched women without diabetes, insulin-treated T1D patients had greater percent dense (8.7% vs. 11.4%) and absolute dense volumes (59.7 vs. 64.7 cm3), and a smaller absolute nondense volume (615 vs. 491 cm3). Similar associations were observed for insulin-treated T2D, and estimates were not materially different in analyses comparing insulin-treated T2D patients with T2D patients receiving noninsulin glucose-lowering medication. In both T1D and T2D, the magnitude of the association with the absolute dense volume was highest for long-term insulin therapy (≥ 5 years) and the long-acting insulin analog glargine. No consistent evidence of differential associations by insulin treatment duration or type was found for percent dense and absolute nondense volumes. Genetically predicted insulin levels were positively associated with percent dense and absolute dense volumes, but not with the absolute nondense volume (percentage difference [95% CI] per 1-SD increase in insulin genetic score = 0.8 [0.0; 1.6], 0.9 [0.1; 1.8], and 0.1 [- 0.8; 0.9], respectively).

    CONCLUSIONS: The consistency in direction of association for insulin treatment and the insulin genetic score with the absolute dense volume suggest a causal influence of long-term increased insulin exposure on mammographic dense breast tissue.

    Matched MeSH terms: Hypoglycemic Agents/adverse effects*
  5. Aravind SR, Ismail SB, Balamurugan R, Gupta JB, Wadhwa T, Loh SM, et al.
    Curr Med Res Opin, 2012 Aug;28(8):1289-96.
    PMID: 22738801 DOI: 10.1185/03007995.2012.707119
    To compare the incidence of symptomatic hypoglycemia between sitagliptin and sulfonylurea in Muslim patients with type 2 diabetes who fasted during Ramadan.
    Matched MeSH terms: Hypoglycemic Agents/adverse effects
  6. Robinson S, Kwan Z, Tang MM
    Dermatol Ther, 2019 07;32(4):e12953.
    PMID: 31044492 DOI: 10.1111/dth.12953
    Insulin, insulin-like growth factor-1 (IGF-1) and essential amino acids activate the mechanistic target of rapamycin complex 1 (mTORC1), the main nutrient-sensitive kinase. Metformin, through inhibition of mTORC1 may improve acne. A 12-week, randomized, open-labeled study evaluated the efficacy and safety of metformin as an adjunct for moderate to severe facial acne. In total, 84 patients received either oral tetracycline 250 mg bd and topical benzoyl peroxide 2.5% with or without metformin 850 mg daily. Evaluations constituted lesion counts, the Cardiff Acne Disability Index (CADI), metabolic parameters and treatment success rate (Investigators Global Assessment score of 0 or 1 or improvement of two grades). Treatment success rates were higher in the metformin group (66.7% vs. 43.2%; p = .04). The mean percentage reduction from baseline in total lesion counts at Week 12 was greater in the metformin group (71.4% vs. 65.3%; p = .278). The CADI scores showed a greater mean reduction in the metformin group (4.82 vs. 4.22; p = .451). Metformin was equally efficacious in improving acne in lean and overweight subjects. Gastrointestinal symptoms were noted in 31.7% of subjects on metformin. This study presents favorable data for metformin as an adjunct for acne treatment. Further randomized placebo-controlled studies are required.
    Matched MeSH terms: Hypoglycemic Agents/adverse effects
  7. Mathiesen ER, Ali N, Alibegovic AC, Anastasiou E, Cypryk K, de Valk H, et al.
    Diabetes Care, 2021 09;44(9):2069-2077.
    PMID: 34330786 DOI: 10.2337/dc21-0472
    OBJECTIVE: To compare the risk of severe adverse pregnancy complications in women with preexisting diabetes.

    RESEARCH DESIGN AND METHODS: Multinational, prospective cohort study to assess the prevalence of newborns free from major congenital malformations or perinatal or neonatal death (primary end point) following treatment with insulin detemir (detemir) versus other basal insulins.

    RESULTS: Of 1,457 women included, 727 received detemir and 730 received other basal insulins. The prevalence of newborns free from major congenital malformations or perinatal or neonatal death was similar between detemir (97.0%) and other basal insulins (95.5%) (crude risk difference 0.015 [95% CI -0.01, 0.04]; adjusted risk difference -0.003 [95% CI -0.03, 0.03]). The crude prevalence of one or more congenital malformations (major plus minor) was 9.4% vs. 12.6%, with a similar risk difference before (-0.032 [95% CI -0.064, 0.000]) and after (-0.036 [95% CI -0.081, 0.009]) adjustment for confounders. Crude data showed lower maternal HbA1c during the first trimester (6.5% vs. 6.7% [48 vs. 50 mmol/mol]; estimated mean difference -0.181 [95% CI -0.300, -0.062]) and the second trimester (6.1% vs. 6.3% [43 vs. 45 mmol/mol]; -0.139 [95% CI -0.232, -0.046]) and a lower prevalence of major hypoglycemia (6.0% vs. 9.0%; risk difference -0.030 [95% CI -0.058, -0.002]), preeclampsia (6.4% vs. 10.0%; -0.036 [95% CI -0.064, -0.007]), and stillbirth (0.4% vs. 1.8%; -0.013 [95% CI -0.024, -0.002]) with detemir compared with other basal insulins. However, differences were not significant postadjustment.

    CONCLUSIONS: Insulin detemir was associated with a similar risk to other basal insulins of major congenital malformations, perinatal or neonatal death, hypoglycemia, preeclampsia, and stillbirth.

    Matched MeSH terms: Hypoglycemic Agents/adverse effects
  8. 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: Hypoglycemic Agents/adverse effects
  9. 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: Hypoglycemic Agents/adverse effects
  10. Bebakar WM, Lim-Abrahan MA, Jain AB, Seah D, Soewondo P
    Diabetes Res Clin Pract, 2013 Apr;100 Suppl 1:S17-23.
    PMID: 23647713 DOI: 10.1016/S0168-8227(13)70005-6
    AIM:
    To examine the clinical safety and effectiveness of insulin aspart (IAsp) therapy in type 2 diabetes (T2D) patients from the ASEAN cohort of the international, 24-week, non-interventional A₁chieve study.

    METHODS:
    T2D patients from Indonesia, Malaysia, Philippines and Singapore, who started IAsp therapy with or without oral glucose-lowering drugs, were included. The primary endpoint was the incidence of serious adverse drug reactions (SADRs), including major hypoglycaemic events. Secondary endpoints included hypoglycaemia, glycated haemoglobin A1c [HbA1c], fasting plasma glucose [FPG], postprandial plasma glucose [PPPG], systolic blood pressure [SBP], body weight and lipids. Quality of life (QoL) was assessed using the EQ-5D questionnaire.

    RESULTS:
    Overall, 312 T2D patients (222 insulin-naive and 90 insulin-experienced) with a mean ± SD age of 56.6 ± 11.2 years, BMI of 24.2 ± 3.9 kg/m(2) and diabetes duration of 7.0 ± 5.7 years were included. The mean daily IAsp dose was 0.51 ± 0.31 U/kg at baseline titrated up to 0.60 ± 0.29 U/kg at Week 24. No SADRs or major hypoglycaemic events were reported in the entire subgroup. The proportion of patients who reported overall hypoglycaemia decreased from baseline to Week 24 (7.1% vs. 0.3%, p < 0.0001). The mean HbA1c improved from 9.5 ± 1.6% at baseline to 7.6 ± 1.3% after 24 weeks (p < 0.001). The mean FPG, post-breakfast PPPG and SBP also improved (p < 0.001). Health-related QoL scores increased in the entire subgroup (mean increase: 9.8 ± 14.6 points, p < 0.001).

    CONCLUSIONS:
    Starting IAsp therapy was well-tolerated and was associated with significantly improved overall glycaemic control in the ASEAN cohort.
    Matched MeSH terms: Hypoglycemic Agents/adverse effects
  11. 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: Hypoglycemic Agents/adverse effects
  12. 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: Hypoglycemic Agents/adverse effects*
  13. 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: Hypoglycemic Agents/adverse effects
  14. 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: Hypoglycemic Agents/adverse effects
  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: Hypoglycemic Agents/adverse effects
  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: Hypoglycemic Agents/adverse effects
  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  
    Matched MeSH terms: Hypoglycemic Agents/adverse effects
  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: Hypoglycemic Agents/adverse effects
  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: Hypoglycemic Agents/adverse effects
  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 
    Matched MeSH terms: Hypoglycemic Agents/adverse effects
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