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Objective: To compare the change in immunogenic response, safety and efficacy of insulin glargine in Glaritus® and Lantus® treatment arms from baseline to six months in patients with type 2 diabetes mellitus (T2DM) uncontrolled on oral antidiabetic drugs (OADs). Material and methods: In an ongoing prospective, open-label, randomized, parallel-group, comparative, multicenter, phase IV study, adult patients with uncontrolled T2DM are treated with either Glaritus® once daily or Lantus® once daily for six months, both given subcutaneously. Glaritus® treatment arm is to be continued for another six months. The primary endpoint for the study was the percentage change in anti-insulin antibodies (AIA) titer to glargine in both treatment arms from baseline to six months. Results: Ninety patients were randomized to each group. Baseline characteristics were comparable between the groups (p>0.05). There was no significant difference in percent change in the AIA titer between the two treatment arms at the end of six months in ITT (intent-to-treat) and mITT(modified intent to treat) population (LS mean diff [95% CI]: 2.2% (-15.1%, 19.6%), p=0.7987 and 3.4% (-15.1%, 21.9%), p=0.7181, respectively). No significant between-group difference was seen in change in the HbA1c level at the end of six months in ITT and mITT population [LS mean diff (95% CI): -0.2 (-0.4, 0.0), p=0.1072 for ITT population; and -0.1 (-0.3, 0.1), p=0.2283, for mITT population]. There was also no significant difference between two groups for the incidence of adverse events [Glaritus® 17 (18.9%) and Lantus® 20 (22.2%) p=0.5800]. Conclusion: Glaritus® was found to be non-inferior to Lantus® in glycaemic control and comparable in immunogenic response and safety at the end of six months in patients with T2DM uncontrolled on OADs.

Introduction Urinary incontinence is a prognostic indicator of mortality and functional recovery in stroke. There is a small evidence base that early intervention within the first three months may improve continence status and subsequent physical and psychological consequences. Methods Utilising a proforma and PDSA, data was collected on the identification and assessment of urinary continence status for patients admitted to a stroke unit. Five agreed standards from NICE (2012) and RCP (2016) guidelines formed the basis of audit. Three cycles of prospective data for a total of 66 patients was collected over four months, implementing quality improvement measures after each cycle. Results 22 participants per cycle. Cycle one demonstrated continence status was identified by the nursing team (100%), and the medical team (41%). However, standards regarding further care planning and assessment (22%), MDT input (11%) and subsequent behavioural and practical interventions (11%) was low. Change strategy, i) awareness training, ii) development of MDT prompt sheet. Cycle two, medical identification (82%), MDT discussion (100%), and continence specific interventions (66%), care planning decreased from 22% to 0%. Change strategy, incontinent patients receive an individualised assessment within 7 days by the advanced nurse practitioner, this assessment should consider all available evidence-based interventions, with the aim of reducing urinary incontinence within the early phases of stroke. Cycle three showed an overwhelming improvement to all five standards, nursing and medical identification (100%, 91. Conclusions PDSA style audit led to quality improvement. The identification of urinary continence status post stroke was high, but due to multifactorial elements often did not progress to assessment or intervention from the MDT. Utilising the existing role of the trainee advanced practitioner patients received evidence-based continence reviews in a timely manner, with no additional cost impact to the service.

Objective: Present Phase IV Trial is aimed at evaluating the immunogenicity, safety, and efficacy of Wockhardt’s insulin glargine, Glaritus® in comparison with reference insulin glargine, Lantus® in subjects with type 2 diabetes mellitus (T2DM), inadequately controlled on oral hypoglycaemics. Setting: A head-to-head, prospective, open-label, parallel group, randomized, Phase IV, non-inferiority study over 6 months treatment conducted in 10 centres in India. Participants: Considering 20% drop-out rate, 180 subjects of either sex, age 18 - 55 years, diagnosed with T2DM with body mass index (BMI) 18 - 38 kg/m2 and HbA1c levels 8.0% - 10.0% inadequately controlled by 1 or more oral hypoglycaemics and according to investigator needed glargine treatment were enrolled in the study. Interventions: Subjects self-administered insulin glargine (Glaritus® or Lantus®) subcutaneously once daily for 6 months. Treatment in Glaritus® arm was continued till 12 months. Percentage change in anti-insulin antibody (AIA) titre and HbA1C was ascertained at every 3 months interval. The tests were performed at accredited central laboratory. Treat-to-target dose titration: Starting doses of Glaritus® and Lantus® was 10 units (or 0.2 units/kg) once daily. The target fasting blood glucose was 70 to 130 mg/dL. Daily glargine dose was titrated by ±10% based on average of last 3 FBG values being out of target range and presence of nocturnal hypoglycemia. Early data trends: First interim analysis was planned once 100 subjects complete visit 8 (6 months treatment). By then, 119 subjects (78 males and 41 females) with mean age 46.3 years were enrolled, of which 90 (75.6%) subjects had evaluable data. The results of analysis indicated trend of comparability between Glaritus® and Lantus® at the end of 6 months in terms of immunogenicity (% change in AIA titre from baseline, −10.52 ± 23.06 vs. 0.48 ± 63.95), glycemic control (change in HbA1c from baseline, −1.09% ± 1.29% vs. 0.63% ± 1.19%) and hypoglycemic events (reported by 1 vs. 2 patients), respectively. Conclusion: The present study represents a robust design in line with international guidelines on biosimilar insulin development and the early data trends presents expected similarity of Glaritus® in immunogenicity, efficacy and safety to that of Lantus® in treatment of T2DM.

Background: Chronic kidney disease is a major risk factor for end stage renal disease, cardiovascular events and death. Various studies have shown an association between metabolic syndrome and CKD. Even mild renal insufficiency increases the risk for cardiovascular events. This study was conducted to detect CKD in its early stages which are characterized by mildly reduced GFR in patients with metabolic syndrome.Methods: This is a cross sectional study of 60 patients, 30 with metabolic syndrome diagnosed on the basis of IDF criteria and 30 controls. EGFR was calculated using the CKD-EPI formula and the results between the two groups was analysed using chi square test for statistical significance.Results: In this study conducted on 60 patients, age distribution was between 20 and 60 years. Male to female ratio was 1:1.06. 26.66% of the cases had normal GFR while among the controls, 46.66% had normal GFR. Out of the 30 cases, 53.33% had mildly reduced GFR while out of the controls, 23.33% had mildly reduced GFR. This association between metabolic syndrome and mildly reduced EGFR was found to be significant (p≤0.05).Conclusions: The results of this study showed that metabolic syndrome is associated with a mildly reduced GFR and hence early detection of these risk factors is essential for treatment and prevention of CKD.

The pathophysiological changes underlying impairment of cognition in Parkinson′s disease (PD) are complex and not fully understood till date. Hence, understanding the structural changes responsible for cognitive decline in PD is essential for early diagnosis and to offer effective treatment. In this review, we discuss the neuroanatomical changes in major brain structures responsible for cognition in PD. We have included the key findings of various studies to provide up-to-date information for better understanding of pathophysiology of PD, which will help researchers and clinicians in planning and developing new treatment methods for the benefit of PD patients.

Background: The thyroid gland, a highly vascular endocrine gland, is composed of two lateral lobes connected by isthmus. A wide range of morphological alterations of the thyroid gland such as hypoplasia, ectopy to hemiagenesis, and genesis are common because of disturbed embryogenesis. The significance of diagnosing such extensions of the thyroid gland is crucial. It may alter the normal anatomical relationship of the thyroid gland with other adjacent cervical structures. Further, it may be confused with a tumor mass on magnetic resonance imaging and scintillation scans. Methods: The primary aim is to study the thyroid gland for gross anatomical variations (weight, height, and breadth) and secondarily to document the morphometric and congenital/developmental variation gross of the thyroid gland in 65 cadavers from the coastal belt of South India. The glands were according to the various age groups of the cadavers. Results: The mean thyroid weight was 26.01 ± 7.14 g. In males, it was 26.59 ± 6.96 g, whereas in females, it was 20.93 ± 8.98 g. The pyramidal lobe was present in 35 (53.8%), and the presence of the levator glandulae thyroideae was noted in 25 (38.48%) of male cadavers. Agenesis of the isthmus was found in 20 (30.76%). However, the accessory thyroid tissue was found in only one female cadaver. Conclusions: Our morphometric study on cadaveric thyroid glands highlights individual and ethnic variations. Knowledge of various developmental anomalies and unusual variations of the thyroid gland is of paramount importance to differentiate it from other pathologies such as autonomous thyroid nodule and thyroiditis.

The objectives were to study the morphology of the foramen magnum in dry skulls and to evaluate its antero-posterior diameter, transverse diameter and the foramen magnum index.The foramen magna of 53 dry human cadaver skulls that were obtained from the neuroanatomy laboratory were examined. Different shapes of the foramen magnum were macroscopically noted and classified. The antero-posterior and transverse diameters were measured and the average foraminal index was calculated.The foramen magnum shapes were determined as a round shape in 22.6% of cases, egg shape in 18.9%, tetragonal in 18.9%, oval in 15.1%, irregular in 15.1%, hexagonal in 5.6% and pentagonal in 3.8% of the cases. In 20.7% of skulls, the occipital condyle was observed to protrude into the foramen. The mean antero-posterior and transverse diameter of the foramen magnum was determined as 31 ± 2.4 mm and 25.2 ± 2.4 mm respectively. The average foramen magnum index was 1.2 ± 0.1.The present study has determined the various shapes of foramen magnum and its morphometry. The data obtained may be of useful to the neurosurgeon in analyzing the morphological anatomy of craniovertebral junction. The findings are also enlightening for the anthropologists, morphologists and clinical anatomists.

Background: The objective structured practical examination (OSPE) is a well accepted tool in practical examinations for both Pre- and Para-clinical subjects. OSPE has been implemented as a part and parcel in practical examinations in most of the advanced countries as it is an effective method to assess the clinical skills of the students. Objective: The present study was aimed to assess the student’s perception about OSPE implementation in practical examination of Anatomy, Physiology and Biochemistry. Materials and Methods: The present study was conducted in 100 male (n=40) and female (n=60) first year medical students. OSPE of Anatomy, Physiology and Biochemistry were prepared in consultation with experts and conducted practical exams using them. A standard questionnaire was used to obtain students perceptions on OSPE. Results: Majority of the students favored implementation of OSPE in the context of scoring and improving thinking and eliminating bias. However, student’s favorable and unfavorable response on stress levels was almost same. Conclusion: Based on student’s feedback, we recommend multi center studies in this area to recommend implementation of OSPE in the curriculum for the benefit of students. Keywords: Anatomy, Biochemistry, Physiology, OSPE, Students perception

The present study is done on 81 adult normal male femora in the Department of Anatomy, S S Institute of Medical Sciences, Davangere. The length of the femur in cms is measured using Osteometric board and the mean femur length is found to be 42.05cms. Using Vernier calipers, the lower maximum mean transverse diameter is measured as 3.3cms and the lower maximum mean sagittal diameter as 2.62cm. Then, the mean popliteal index is calculated to be 79.6. When the length of the femur is correlated with all the above measurements, it is found that the length of the femur showed highly significant correlation with the lower maximum sagittal diameter of the femur (‘p’ value- 0.000), the maximum transverse diameter of the femur (‘p’-value- 0.001) and the popliteal index (‘p’ value0.008).

Comparative histology of Coronary artery, Internal Thoracic Artery (ITA), Radial artery and Sephanous vein was studied in Dept of Anatomy, JSS Medical College, Mysore, Karnataka. Routine histological processing and sectioning was done. Sections were studied using H & E staining and Verhoeff Van Gieson's special staining procedure for elastic fibres was done. It was noted that histologically, internal thoracic artery and coronary arteries appear similar having tunica media predominantly of elastic fibres and prominent internal elastic and external elastic lamina. Tunica adventia of both coronary and ITA are found to be containing more of elastic fibres.

Larger regions of connective tissue in developing skull where multiple sutures meet are called Fontanelles. In total, there are six fontanelles. As growth and ossification progress, the connective tissue of the fontanelle is invaded and replaced by bone. 50 foetal skulls obtained from the Department of Obstetrics and Gynaecology, AIMS, Kochi, was studied in detail in the present study. The skulls were studied to note any gross abnormalities, and measurements of the anterior fontanelle were recorded, tabulated and its relation to gestational age was studied