exudates and Hypoglycemia

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  < .0001) in lowering HbA1c than either alogliptin or metformin alone. The safety profile of alogliptin + metformin FDC was similar to that of the individual components alogliptin and metformin. The study demonstrated that treatment with alogliptin + metformin FDC BID resulted in better glycaemic control than either monotherapy and was well tolerated in Asian patients with type 2 diabetes.

Topics: China; Combined Modality Therapy; Diabetes Mellitus, Type 2; Diet, Diabetic; Dipeptidyl-Peptidase IV Inhibitors; Drug Therapy, Combination; Exercise; Glycated Hemoglobin; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Immunity, Mucosal; Incidence; Malaysia; Metformin; Middle Aged; Piperidines; Republic of Korea; Respiratory Tract Infections; Taiwan; Uracil

This pilot study evaluated the short-term benefits of a telemonitoring-supplemented focused diabetic education compared with education alone in participants with Type 2 diabetes who were fasting during Ramadan.. In this pilot mixed-method study, we identified 37 participants and randomly allocated them to either a telemonitoring group (n = 18) or a group receiving Ramadan-focused pre-education only (usual care; n = 19). The telemonitoring group received goal-setting and personalized feedback.. The telemonitoring group was less likely to experience hypoglycaemia than the usual care group (odds ratio: 0.1273; 95% confidence interval: 0.0267-0.6059). No significant differences were noted in glycaemic control at the end of study. Participants viewed telemedicine as a more convenient alternative although technological barriers remain a concern.. The results of this study reinforce the need for monitoring as well as educational initiatives for Muslims with diabetes who fast during Ramadan. Telemonitoring offers an attractive option requiring further research. (Clinical Trial Registry No. NCT02189135).

Topics: Adolescent; Adult; Aged; Anniversaries and Special Events; Diabetes Mellitus, Type 2; Diet, Diabetic; Fasting; Feedback, Psychological; Goals; Humans; Hypoglycemia; Islam; Malaysia; Middle Aged; Patient Compliance; Patient Education as Topic; Patient Preference; Pilot Projects; Precision Medicine; Risk; Telemedicine; Young Adult

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.. 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.. 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 < 0.0001) and a significant reduction in fasting plasma glucose (p = 0.0109). There was no difference in weight loss versus placebo, with a modest reduction in body weight reported for both groups (lixisenatide: -1.50 kg, placebo: -1.24 kg; p = 0.296). The incidence of treatment-emergent adverse events (TEAEs) was 64.3% with lixisenatide versus 47.4% with placebo, with serious TEAEs reported in 1.5% versus 2.1% of patients, respectively. The most common TEAE in the lixisenatide group was nausea (16.3% vs 2.6% with placebo). The incidence of symptomatic hypoglycaemia was 5.6% with lixisenatide treatment and 2.6% with placebo (p = 0.1321), with no severe symptomatic hypoglycaemia events reported.. In Asian patients with type 2 diabetes mellitus insufficiently controlled on metformin ± sulfonylurea, lixisenatide significantly improved glycaemic control and was well tolerated during the 24-week study.

Topics: Adult; China; Diabetes Mellitus, Type 2; Double-Blind Method; Drug Resistance; Drug Resistance, Multiple; Drug Therapy, Combination; Female; Glucagon-Like Peptide-1 Receptor; Glycated Hemoglobin; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Malaysia; Male; Metformin; Middle Aged; Nausea; Peptides; Receptors, Glucagon; Sulfonylurea Compounds; Thailand

To compare the incidence of symptomatic hypoglycemia between sitagliptin and sulfonylurea in Muslim patients with type 2 diabetes who fasted during Ramadan.. In a multicenter, pragmatic, randomized study, patients with type 2 diabetes were recruited from clinical centers in India (n = 765) and Malaysia (n = 105). Eligible patients (age ≥ 18 yrs) expressed their intention to daytime fast during Ramadan, were treated with a stable dose of sulfonylurea with or without metformin for ≥3 months prior to screening visit, and had an HbA(1c) ≤ 10%. Patients were randomized in a 1:1 ratio to either switch to sitagliptin 100 mg q.d. or remain on their pre-study sulfonylurea. Daily diary cards were completed to document information on hypoglycemic symptoms and complications. The primary endpoint was the overall incidence of symptomatic hypoglycemia during Ramadan.. Of the 870 patients randomized, 848 (n = 421 for sitagliptin and 427 for sulfonylurea) returned ≥1 completed diary card and were included in the analysis. The proportion of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan was lower with sitagliptin (3.8%) compared to sulfonylurea (7.3%). The risk of symptomatic hypoglycemia was significantly lower with sitagliptin (risk ratio [95% CI] = 0.52 [0.29, 0.94]; p = 0.028). By country, the proportions of patients who recorded ≥1 symptomatic hypoglycemic event during Ramadan were 4.1% vs. 7.7% in India and 1.9% vs. 3.8% in Malaysia for sitagliptin and sulfonylurea, respectively. No patient discontinued treatment due to a hypoglycemic event. One patient on sitagliptin and seven on sulfonylurea had an event that required non-medical assistance. No events required medical assistance. Both treatments were generally well tolerated.. Symptomatic hypoglycemic events did not require a confirmatory blood glucose measurement, which may have overestimated hypoglycemic events. Measures of glycemic control and body weight were not assessed.. Switching antihyperglycemic treatment to sitagliptin from a sulfonylurea reduced the risk of symptomatic hypoglycemia by approximately 50% for Muslim patients with type 2 diabetes who fasted during Ramadan.. Clinicaltrials.gov: NCT01340768.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Diabetes Mellitus, Type 2; Fasting; Female; Humans; Hypoglycemia; Hypoglycemic Agents; India; Islam; Malaysia; Male; Middle Aged; Pyrazines; Sitagliptin Phosphate; Sulfonylurea Compounds; Triazoles; Young Adult

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.

Topics: Biomarkers; Carbamates; Diabetes Mellitus, Type 2; Fasting; Feeding Behavior; Female; Fructosamine; Glyburide; Humans; Hypoglycemia; Hypoglycemic Agents; Islam; Malaysia; Male; Middle Aged; Piperidines; Risk Factors; Safety; Time Factors

Insulin degludec (IDeg)/insulin aspart (IAsp; IDegAsp) is a co-formulation of 70% IDeg and 30% IAsp. According to several randomized controlled trials, IDegAsp is effective and safe for patients with type 2 diabetes mellitus (T2DM). A subgroup analysis of the ARISE study was conducted to explore the safety and efficacy of IDegAsp among Malaysian patients with T2DM in real-world settings.. ARISE, an open-label, multicenter, non-interventional, prospective study was conducted between August 2019 and December 2020. Adult Malaysian patients with T2DM who were enrolled from 14 sites received IDegAsp as per the local label for 26 weeks. The primary endpoint was change in glycated hemoglobin (HbA1c) levels from baseline to end of study (EOS).. Of the 182 patients included in the full analysis set, 159 (87.4%) completed the study. From baseline to EOS, HbA1c (estimated difference [ED]: -1.3% [95% CI: -1.61 to -0.90]) and fasting plasma glucose levels (ED: -1.8 mmol/L [95% CI: -2.49 to -1.13]) were significantly reduced (. Switching or initiating IDegAsp treatment resulted in significant improvements in glycemic control and a reduction in hypoglycemic episodes.

Topics: Adult; Blood Glucose; Diabetes Mellitus, Type 2; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin Aspart; Malaysia; Prospective Studies

Glycogen storage disease type 1a (GSD1a) is a rare autosomal recessive metabolic disorder characterized by hypoglycaemia, growth retardation, lactic acidosis, hepatomegaly, hyperlipidemia, and nephromegaly. GSD1a is caused by a mutation in the. To elaborate on the clinical findings, biochemical data, molecular genetic analysis, and short-term prognosis of 13 GSD1a patients in Malaysia.. The information about 13 clinically classified GSD1a patients was retrospectively studied. The. Patients were presented with hepatomegaly (92%), hypoglycaemia (38%), poor weight gain (23%), and short stature (15%). Mutation analysis revealed nine heterozygous mutations; eight previously reported mutations (c.155 A > T, c.209 G > A, c.226 A > T, c.248 G > A, c.648 G > T, c.706 T > A, c.1022 T > A, c.262delG) and a novel mutation (c.325 T > C). The most common mutation found in Malaysian patients was c.648 G > T in ten patients (77%) of mostly Malay ethnicity, followed by c.248 G > A in 4 patients of Chinese ethnicity (30%). A novel missense mutation (c.325 T > C) was predicted to be disease-causing by various. The establishment of

Topics: Glucose; Glucose-6-Phosphatase; Glucose-6-Phosphate; Glycogen Storage Disease; Glycogen Storage Disease Type I; Hepatomegaly; Humans; Hypoglycemia; Malaysia; Mutation; Phosphates; Retrospective Studies

The objective of this study was to determine admissions for diabetes emergencies among patients who fasted or planned to fast one month before, during and one month after Ramadan 2019 in public hospitals in Malaysia.. This was a cross sectional prospective study done in 18 public hospitals in Malaysia from 7/4/2019 to 2/7/2019. Data was collected prospectively with universal sampling. All adult Muslim patients with previous diagnosis of diabetes, who were admitted for hypoglycemia, DKA or HHS were included if they had fasted and had intentions to fast.. 295 admissions for diabetes emergencies were analyzed. The pre-Ramadan period recorded the highest number of admissions (119) followed by during (106) and post-Ramadan (70). Admissions for hyperglycemic emergencies accounted for 2/3 of total admissions. 37% of admissions for hypoglycemia occurred during pre-Ramadan period compared to 32.1% during Ramadan. Contributing factors included use of sulphonylurea (59.6%), presence of nephropathy (54.5%) and past history of hypoglycemia (45.5%). Admissions for DKA were more common than HHS (119 versus 77) and highest during Ramadan period (36.1%). Most of the admissions for hyperglycemic emergencies were among those with Type 2 diabetes (75.9% for DKA and 97.4% for HHS). Only 31.5% of patients admitted for diabetes emergencies recalled having received Ramadan advice in the past.. Admissions for diabetes emergencies were highest during pre-Ramadan period followed by Ramadan and post-Ramadan period. This suggests that fasting during Ramadan does not increase admissions for diabetes emergencies.

Topics: Cross-Sectional Studies; Diabetes Mellitus, Type 2; Emergencies; Fasting; Female; Hospitalization; Humans; Hypoglycemia; Islam; Malaysia; Male; Middle Aged; Prospective Studies

This study mainly aims to identify the direct cost and economic burden of hypoglycemia for patients with type II diabetes mellitus in Malaysia. A cross-sectional study explored the cost incurred for hypoglycemia among patients admitted to University Kebangsaan Malaysia Medical Centre (UKMMC). The study covered patients aged 20-79 years hospitalized with a primary diagnosis of ICD-10 hypoglycemia and discharged between January 2010 and September 2015 according to the casemix database. A costing analysis was done through a step-down approach from the perspective of health providers. Cost data were collected for three levels of cost centers with the help of a hospital-costing template. The costing data from UKMMC were used to estimate the national burden of hypoglycemia among type II diabetics for the whole country. Of 244 diabetes patients admitted primarily for hypoglycemia to UKMMC, 52% were female and 88% were over 50 years old. The cost increased with severity. Managing a hypoglycemic case requires five days (median) of inpatient stay on average, with a range of 2-26 days, and costs RM 8,949 (USD 2,289). Of the total cost, 30% related to ward (final cost center), 16% to ICU, and 15% to pharmacy (secondary-level cost center) services. Considering that 3.2% of all admissions were hypoglycemia related, the total annual cost of hypoglycemia care for adult diabetics in Malaysia is estimated at RM 117.4 (USD 30.0) million, which translates to 0.5% of the Ministry of Health budget. Hypoglycemia imposes a substantial economic impact even without the direct and indirect cost incurred by patients and other cost of complications. Diabetic management needs to include proper diabetic care and health education to reduce episodes of hypoglycemia.

Topics: Adult; Aged; Cost of Illness; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Female; Hospitalization; Humans; Hypoglycemia; Malaysia; Male; Middle Aged; Pharmacy Service, Hospital

The present Malaysian cohort analysis determined the prevalence of hypoglycemia among patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) attending primary care- or hospital-based diabetes clinics in Malaysia and their awareness of the symptoms of hypoglycemia.. The Hypoglycemia Assessment Tool (HAT) study was a non-interventional, 6-month retrospective and 4-week prospective analysis of hypoglycemic events in 24 countries, using self-assessment questionnaires and diaries among patients with T1DM/T2DM aged ≥18years, using insulin for >12months. This report focuses on prospective data, as they are less prone to recall bias.. There were 1153 participants in the Malaysian cohort (114 T1DM; 1039 T2DM). In the prospective period, 50.4% and 33.4% of patients reported ≥1 hypoglycemic events, with estimated rates of 20.3 and 13.1 events per patient-year of exposure in patients with T1DM and T2DM, respectively. 24.8% and 16.1% of patients with T1DM or T2DM, respectively, reported ≥1 nocturnal hypoglycemic event. The majority of patients (96.5%, T1DM; 91.8%, T2DM) knew what hypoglycemia was prior to the study. Impaired awareness was present in 48.0% (T1DM) and 36.9% (T2DM) of patients. In the prospective period, 50% of patients with T1DM or T2DM consulted a doctor or nurse following a hypoglycemia episode.. Half of patients with T1DM and a third of patients with T2DM reported ≥1 hypoglycemic event during the prospective period. Although the majority of patients knew the typical features of hypoglycemia, many reported impaired ability to recognize symptoms in real life. The present findings highlight the importance of patient education and physician awareness in dealing with hypoglycemia, in particular the burden of hypoglycemic unawareness.. This trial was registered at www.clinicaltrials.gov as NCT01696266 on 26 September 2012.

Topics: Adult; Awareness; Cohort Studies; Diabetes Complications; Diabetes Mellitus, Type 1; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Malaysia; Male; Middle Aged; Prospective Studies; Retrospective Studies

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.. 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).. 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).. Hypoglycemic symptoms were associated with reduced quality of life and increased patient worry in patients with type 2 diabetes treated with AHA.

Topics: Administration, Oral; Aged; Anxiety; China; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Female; Humans; Hypoglycemia; Hypoglycemic Agents; Korea; Malaysia; Male; Middle Aged; Quality of Life; Surveys and Questionnaires; Taiwan; Thailand

Micropenis is an important sign in congenital hypopituitarism and various disorders. Documented norms for penile length exist only for babies of Caucasian and Middle-Eastern origin. This study was carried out to establish such norms for Asian newborns. We studied 228 male live births within their first three days of life. Stretched penile lengths were marked off on unmarked wooden spatulas, which were placed vertically along the dorsal aspect of the penis, with one rounded end on the pubic bone. The mean penile length +/- S.D. for the full-term Asian baby was 3.6 +/- 0.4 cm. Race had a significant effect: Chinese 3.5 cm, Malay 3.6 cm and Indian 3.8 cm. Penile length correlated with birth weight and gestational age. Asian babies thus have similar norms to Caucasian babies. An Asian newborn whose penis measures less than 2.6 cm has micropenis and may need prompt investigation for underlying endocrine disorders.

Topics: Birth Weight; China; Gestational Age; Humans; Hypoglycemia; Hypopituitarism; India; Infant, Newborn; Malaysia; Male; Penis; Reference Values; Regression Analysis; Reproducibility of Results; Singapore