Overexpression of cyclin D1 is a hallmark feature of mantle cell lymphoma (MCL). Many of the oncogenic effects of cyclin D1 are mediated through cyclin dependent kinases (CDKs). P276-00 is a potent small-molecule inhibitor of CDK4-D1, CDK1-B, and CDK9-T with promising activity in pre-clinical models. In Phase I studies of P276-00 in patients with refractory solid neoplasms, it was well-tolerated with a mild trend of single-agent efficacy. A Phase II study of this agent was conducted in patients with relapsed or refractory MCL at the recommended dose of 185 mg/m2/day from days 1-5 of a 21-day cycle. Thirteen patients were enrolled on this study: 11 patients had disease progression, 1 patient was withdrawn due to an adverse event (AE), and 1 patient died. Eleven patients (84.6%) experienced a treatment-emergent AE deemed related to P276-00. Nine patients (69.2%) received at least 2 cycles of treatment, which was the pre-defined threshold to be evaluable for efficacy; treatment was discontinued early in 2 patients due to AEs (one of which was attributed to P276-00 administration) and in 2 patients due to disease progression. Two patients experienced stable disease for an estimated median duration of 60.5 days (range 58-63 days). The estimated median time to progression for the pre-defined efficacy population was 43 days (range 38-58 days). Given the results observed in this study, if continued evaluation of CDK inhibition in MCL occurs, it should be considered earlier in the disease course or as part of combination strategies for relapsed or refractory disease.

Background: Hypoglycemia is the limiting factor in the glycemic management of diabetes, which need to be addressed critically to avoid complications. Lockdown because of new coronavirus strain (COVID-19) pandemic has further complicated the issue of hypoglycemia due to limitations in access to food, outpatient clinics, pathological services and medicines. Aim: To assess the factors associated with the risk of hypoglycemia during AprileMay 2020 lockdown in people with type 2 diabetes mellitus. Methodology: We analyzed the data retrospectively from 146 patients of type 2 diabetes mellitus (T2DM) reporting to the emergency department (ED) during lockdown period with symptoms suggestive of hypoglycemia. Results: The majority of patients were male (90/146) with a mean age of 59.88 ± 10.09 years and a mean random blood glucose level of 57.67 ± 9.00 mg/dL. Two-third of patients (70.83%) had level 1 hypoglycemia, while level 2 hypoglycemia was reported in 29.16% of patients. A combination of Metformin and Sulfonylureas (SU) was most commonly associated with the risk of hypoglycemia (65.75%) followed by insulin (33.56%). Subjects who received insulin reported a lower blood glucose value (50.75 ± 8.20 mg/dL) as compared to those receiving a combination of metformin and SU (60.95 ± 7.10 mg/dl). 330.56% of patients who had received prophylaxis hydroxychloroquine (HCQ) 400 mg twice a day along with the routine anti-hyperglycemic agents without their dose adjustment reported hypoglycemia. Patients with hypertension, micro-vascular, macro-vascular complications, and coexistent with each other had a higher propensity to the risk of hypoglycemia (46.58%, 33.56%, 23.29%, and 32.88%) respectively. Conclusion: The COVID-19 lockdown has shown to influence the risk of hypoglycemia in patients with T2DM, especially those receiving SU, insulin, HCQ especially in patients with associated co-morbidities. Patient education, support, and telemedicine plays a pivotal role to prevent hypoglycemia.

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Highlights Individuals reporting Self-Monitoring of Blood Glucose more than 140 mg/dl reduced to 18% during lockdown from 32.6%. There were 81% and 74% increase in people who were unable to SMBG for fasting and post prandial glucose, respectively. Participants reporting a decrease in weight (16.3%) were more than those reporting an increase in weight (14.8%).

Context: Bitter melon (Momoradica charantia) is one of the well-known plants used for lowering blood glucose since antiquity. Aims: To compare the efficacy and safety of PDM011011 capsule (1200 mg/day) with Metformin (1000 mg/day) in a 15 weeks study using mean change in fasting plasma glucose (FPG) and Hb1Ac% in subjects with type 2 diabetes mellitus (T2DM). Settings and