Background:Dual PPARα/γ can improve both metabolic effects and minimized the side effects caused by either PPARα or PPARγ agonist. The PRESS V study was aimed to evaluate the safety, tolerability, and efficacy of saroglitazar 2 mg and 4 mg capsules (Lipaglyn™; Zydus Code: ZYH1) as compared to high dose pioglitazone in patients with diabetic dyslipidemia.Methods:In this 26-week double-blind, parallel arm, phase 3 study patients with hypertriglyceridemia with type 2 diabetes mellitus (BMI > 23 kg/m2; hypertriglyceridemia: TG > 200 to 400 mg/dL; glycosylated hemoglobin [HbA1c] >7 to 9%) were enrolled from 14 sites in India. After 2 weeks of lifestyle modification, 122 patients were randomized double-blind to 24-week treatment with the study drugs (saroglitazar 2 mg or 4 mg or pioglitazone 45 mg once daily) in a 1:1:1 ratio. The primary end point was change in plasma triglyceride level at week 24. The secondary end points were change in lipid profile and fasting plasma glucose at week 24. Patients who received study medication and had undergone at least 1 postbaseline efficacy evaluation were included in the efficacy analysis. All randomized patients who received at least a single dose were included for safety evaluation.Results:The efficacy analysis included 109 patients (n = 37 in saroglitazar 2 mg; n = 39 in saroglitazar 4 mg; n = 33 in pioglitazone). Saroglitazar 2 mg and 4 mg significantly reduced (P < .001) plasma triglyceride from baseline by 26.4% (absolute change ± SD: −78.2 ± 81.98 mg/dL) and 45% (absolute change ± SD −115.4 ± 68.11 mg/dL), respectively, as compared to pioglitazone -15.5% (absolute change ± SD: −33.3 ± 162.41 mg/dL) at week 24. Saroglitazar 4 mg treatment also demonstrated marked decrease in low-density lipoprotein (5%), very-low-density lipoprotein (45.5%), total cholesterol (7.7%), and apolipoprotein-B (10.9%). Saroglitazar treatment was generally safe and well tolerated. No serious adverse events were reported in saroglitazar treatment arm and no persistent change in laboratory parameters.Conclusions:Saroglitazar appeared to be an effective and safe therapeutic option for improving hypertriglyceridemia in patients with type 2 diabetes mellitus.

Women with gestational diabetes mellitus (GDM) are at an increased risk of developing diabetes in the future, as are their offspring. GDM is not only of clinical relevance, but is also an important public health issue. A community-based prospective study showed that the prevalence of GDM was 13.9%. We also observed that the frequency of GDM varied across urban, semi-urban, and rural areas. Based on multiple logistic regression analysis and taking the 3 areas into consideration, family history of diabetes, age greater than or equal to 25 years, and body mass index greater than or equal to 25 were found to have a significant independent association with GDM (P<0.001).

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The CBG value at a 2-h plasma glucose level of ≥7.8 mmol/L may be recommended for the diagnosis of GDM in healthcare centers where laboratory technology is not available.

Background:The A1chieve, a multicentric (28 countries), 24-week, non-interventional study evaluated the safety and effectiveness of insulin detemir, biphasic insulin aspart and insulin aspart in people with T2DM (n = 66,726) in routine clinical care across four continents.Materials and Methods:Data was collected at baseline, at 12 weeks and at 24 weeks. This short communication presents the results for patients enrolled from Chennai, India.Results:A total of 1334 patients were enrolled in the study. Four different insulin analogue regimens were used in the study. Patients had started on or were switched to biphasic insulin aspart (n = 983), insulin detemir (n = 205), insulin aspart (n = 42), basal insulin plus insulin aspart (n = 41) and other insulin combinations (n = 63). At baseline glycaemic control was poor for both insulin naïve (mean HbA1c: 9.4%) and insulin users (mean HbA1c: 9.3%) groups. After 24 weeks of treatment, both groups showed improvement in HbA1c (insulin naïve: −2.1%, insulin users: −1.9%). SADRs including major hypoglycaemic events or episodes did not occur in any of the study patients.Conclusion:Starting or switching to insulin analogues was associated with improvement in glycaemic control with a low rate of hypoglycaemia.