Insulin glargine 300 U/mL for basal insulin therapy in type 1 and type 2 diabetes mellitus.

OBJECTIVE: To review published clinical studies on the efficacy and safety of new insulin glargine 300 units/mL (Gla-300), a new long-acting insulin analog, for the treatment of type 1 and type 2 diabetes mellitus (T1DM, T2DM). MATERIALS AND METHODS: Data sources comprised primary research articles on Gla-300, including pharmacodynamic, pharmacokinetic, and clinical studies. RESULTS: In pharmacodynamic and pharmacokinetic studies, Gla-300 showed a flatter time-action profile and longer duration of action than Gla-100. Noninferiority of Gla-300 versus Gla-100 for lowering of glycated hemoglobin was demonstrated in Phase III clinical studies covering a range of T1DM and T2DM patient populations. Over 6-12 months of follow-up, Gla-300 consistently showed comparable glycemic efficacy with less hypoglycemia vs Gla-100, even during the first 8 weeks of treatment. Although titrated insulin doses were 11%-17% higher with Gla-300 vs Gla-100, changes in body weight were similar or favored Gla-300. CONCLUSION: Clinical studies provide evidence that the pharmacodynamic and pharmacokinetic properties of Gla-300 may translate into clinical benefits in both T1DM and T2DM. Gla-300 may provide a new option for people initiating basal insulin, those requiring higher basal insulin doses, those with T1DM, and those who may be at increased risk for hypoglycemia, such as people with chronic kidney disease, the elderly, and those with cardiovascular comorbidities.

Association between Auricular Signals and the Risk Factors of Metabolic Syndrome.

Objective: This study aims to determine the association between auricular signals and the risk factors of metabolic syndrome (MS). Methods: A case-control study with an equal number of cases and controls matched by age group and gender was conducted. A total of 204 participants were recruited. Patients were verified as having MS based on the International Diabetes Federation (IDF) criteria. Auricular assessment was conducted in the following sequence: visual inspection, electrical skin resistance test (ESRT), and pressure pain test (PPT). Results: MS+ patients tend to have much more oily auricle complexion than the controls. The 'endocrine' (right) of the participants with MS indicated a significantly higher electrical conductivity compared to that of the controls. The MS group participants experienced significant tenderness on the 'heart' and 'endocrine' acupoints. A number of auricular signals were also associated with the risk factors of MS, including age, gender, smoking status, family history of diabetes, and comorbid illnesses. Both the 'heart' and 'endocrine' acupoints showed the highest sensitivity to tenderness (60.8%), followed by the 'endocrine' (59.8%) and 'pancreas and gallbladder' (55.9%). Conclusions: The results of this study suggest that electrical conductivity and tenderness of a number of auricular points, including the 'heart', 'pancreas and gall bladder', and 'endocrine', are associated with MS and its risk factors. Further investigations with a larger sample size could be conducted to verify the value of these auricular signals on MS risk prediction so that this method can be used as an early screening method for the population with a high MS risk.

Association of Auricular Reflective Points and Status of Type 2 Diabetes Mellitus: A Matched Case-Control Study.

The reflexive property of the ear can cause various physical attributes to appear on the auricle in the presence of bodily disorders. The association of auricular signals (presence or absence of discoloration, marks after pressing, tenderness, and electrical resistance) and diabetes mellitus (DM) should be further investigated because auricular diagnosis is an objective, painless, and noninvasive method that provides rapid access to information. A matched case-control study on 282 subjects was conducted. Cases (n = 141) were defined as those diagnosed with type 2 DM (T2DM). Every subject in the case group was matched with the control by age and gender. Ear diagnosis was conducted in three aspects: inspection, electrical detection, and tenderness testing. Results suggest that the tenderness and electrical conductivity of some auricular points, including "pancreas and gallbladder," "endocrine," "kidney," "lower tragus," "heart," and "eyes," were associated with T2DM status in Chinese population. In the subgroup analyses, certain auricular signals were also associated with glycemic control, disease duration, and related complications. Auricular diagnosis could be considered as a screening method for vulnerable populations with T2DM risk. Thus, appropriate interventions can be implemented to prevent or delay the progression of T2DM.

Development and validation of the Chinese Attitudes to Starting Insulin Questionnaire (Ch-ASIQ) for primary care patients with type 2 diabetes.

OBJECTIVES: To develop and evaluate the psychometric properties of a Chinese questionnaire which assesses the barriers and enablers to commencing insulin in primary care patients with poorly controlled Type 2 diabetes. RESEARCH DESIGN AND METHOD: Questionnaire items were identified using literature review. Content validation was performed and items were further refined using an expert panel. Following translation, back translation and cognitive debriefing, the translated Chinese questionnaire was piloted on target patients. Exploratory factor analysis and item-scale correlations were performed to test the construct validity of the subscales and items. Internal reliability was tested by Cronbach's alpha. RESULTS: Twenty-seven identified items underwent content validation, translation and cognitive debriefing. The translated questionnaire was piloted on 303 insulin naïve (never taken insulin) Type 2 diabetes patients recruited from 10 government-funded primary care clinics across Hong Kong. Sufficient variability in the dataset for factor analysis was confirmed by Bartlett's Test of Sphericity (P<0.001). Using exploratory factor analysis with varimax rotation, 10 factors were generated onto which 26 items loaded with loading scores > 0.4 and Eigenvalues >1. Total variance for the 10 factors was 66.22%. Kaiser-Meyer-Olkin measure was 0.725. Cronbach's alpha coefficients for the first four factors were ≥0.6 identifying four sub-scales to which 13 items correlated. Remaining sub-scales and items with poor internal reliability were deleted. The final 13-item instrument had a four scale structure addressing: 'Self-image and stigmatization'; 'Factors promoting self-efficacy; 'Fear of pain or needles'; and 'Time and family support'. CONCLUSION: The Chinese Attitudes to Starting Insulin Questionnaire (Ch-ASIQ) appears to be a reliable and valid measure for assessing barriers to starting insulin. This short instrument is easy to administer and may be used by healthcare providers and researchers as an assessment tool for Chinese diabetic primary care patients, including the elderly, who are unwilling to start insulin.

Heme oxygenase microsatellite polymorphism, oxidative stress, glycemic control, and complication development in type 2 diabetes patients.

Heme oxygenase-1 (HMOX-1) is activated by oxidative stress, and gene responsiveness is reportedly determined by the number of dinucleotide (GT(n)) repeats in its highly polymorphic promoter region. "Short" (S; GT(n)<25) alleles reportedly associate with higher response, lower oxidative stress, lower risk of type 2 diabetes mellitus (type 2DM), and better glycemic control and outcome, but data are conflicting. We investigated GT(n) in type 2DM subjects (all ethnic Chinese) in relation to basal glycemic control, oxidative stress, and outcome during up to 9 years' follow-up. Fasting blood from 418 type 2 DM subjects was collected at entry for GT(n) genotyping, glycated hemoglobin, glucose, lipids, and biomarkers of oxidative stress and antioxidants. A subset (n=368) was followed for up to 9 years for incident complications or death. GT(n) genotype distribution was 128, 182, and 108 for, respectively, S/S, S/L, and L/L. No significant differences in glycemic control, lipids, or oxidative stress were seen across genotypes. During follow-up, 168/368 subjects developed complications. No association was seen with GT(n). No difference in plasma HO-1 was seen between genotypes in a small substudy (S/S n=21 vs L/L n=23). Glycated hemoglobin and lymphocytic DNA damage was higher (p<0.05) at entry in the incident complications group. No other significant differences were seen in oxidative stress or antioxidants. Data do not support the postulated link between HMOX-1 microsatellite polymorphism and type 2 DM or the putative beneficial effect of the S allele on glycemic control, oxidative stress, or outcome in type 2 DM patients, at least in this particular population.

Tuberculous pericarditis presenting as massive haemorrhagic pericardial effusion.

Tuberculous pericarditis is an exceedingly rare but a well-described extra-pulmonary manifestation of tuberculosis (TB) infection in Hong Kong. An 82-year-old woman with a known history of diabetes mellitus, hypertension and hyperlipidaemia was admitted for congestive heart failure. Routine echocardiographic study during admission revealed a massive pericardial effusion (~4 cm in thickness) but with no tamponade effect. Pericardiocentesis was performed and 1.6 L of heavily blood stained fluid was drained. All tumour and auto-immune markers were unremarkable. A whole body positron emission tomography-computer tomography (PET-CT) scan was then performed and showed an increased fluorodeoxyglucose uptake in the entire pericardium with no sources of possible malignancy identified. Rapid acid fast bacilli culture and Genprobe examination of the pericardial fluid then demonstrated the growth of Mycobacterium tuberculosis. She was started on anti-TB medications and tolerated them well. Follow-up echocardiographic study showed no re-accumulation of pericardial fluid.

First insulinization with basal insulin in patients with Type 2 diabetes in a real-world setting in Asia.

BACKGROUND: The First Basal Insulin Evaluation (FINE) Asia study is a multinational, prospective, observational study of insulin-naïve Type 2 diabetes mellitus (T2DM) patients in Asia, uncontrolled (A1c ≥ 8%) on oral hypoglycemic agents, designed to evaluate the impact of basal insulin initiation. METHODS: Basal insulin was initiated with or without concomitant oral therapy and doses were adjusted individually. All treatment choices, including the decision to initiate insulin, were at the physician's discretion to reflect real-life practice. RESULTS: Patients (n=2679) from 11 Asian countries were enrolled (mean [±SD] duration of diabetes 9.3±6.5 years; weight 68.1±12.7 kg; A1c 9.8 ± 1.6%). After 6 months of basal insulin (NPH insulin, insulin glargine, or insulin detemir), A1c decreased to 7.7±1.4%; 33.7% patients reached A1c <7%. Fasting blood glucose (FBG) decreased from 11.7±3.6 to 7.2±2.5 mmol/L and 36.8% of patients reached FBG <6.1 mmol/L. The mean daily insulin dose prescribed increased marginally from 0.18 to 0.23 U/kg per day at baseline to 0.22-0.24 U/kg per day at Month 6. Mean changes in body weight and reported rates of hypoglycemia were low over the duration of the study. CONCLUSIONS: Initiation of insulin therapy is still being delayed by approximately 9 years, resulting in many Asian patients developing severe hyperglycemia. Initiating insulin treatment with basal insulin was effective and safe in Asian T2DM patients in a real-world setting, but insulin needs may differ from those in Western countries.