Adherence and Swallowing Experience with a Modified, Smaller-sized Tablet Formulation of Metformin and Glimepiride (SR) in Indian Patients with Type 2 Diabetes Mellitus.

BACKGROUND: This study evaluated the adherence and swallowing experience with novel oval-shaped, compact-sized metformin (500 mg/1000 mg)-glimepiride (1mg/2mg) combination, sustained-release tablet (Gluformin G1/Gluformin G2 SR; GM-new-SR) in Indian patients with T2DM, previously treated with conventional metformin-glimepiride combination tablet. METHODS: Patients' adherence, swallowing experience, and satisfaction were assessed at baseline and month-3 by Adherence to Refills and Medication Scale (ARMS12; adherent: ARMS12 score=12; nonadherent: ARMS12 score >12) and questionnaire based 5-point Likert scale, respectively. Safety was also assessed. RESULTS: Of 1550 patients enrolled, 1547 (99.8%) completed the study. After 3 months of switching to GM-new-SR tablets, adherence rate increased from 4.38% to 91.1%, with concurrent reduction in mean ARMS-12 score by 6.3±4.36 (p<0.0001). Compared to baseline, all glycemic indices, HbA1c, PPG, and FPG, significantly improved (p<0.0001) in the overall population. Reduction in HbA1c levels was significant only in patients who were adherent to therapy as opposed to nonadherent patients (7.8±1.74 to 7.1±0.85, p<0.0001 vs. 7.7±1.39 to 6.7±0.77, p=0.4276). Most patients attributed ease of swallowing of GM-new-SR tablets to its modified shape (95.5%) and size (94.9%). Most patients (90.4%) were satisfied with the new tablet formulation. Size of the tablet was the most common reason for patients' nonadherence with conventional tablets, which was reported to be less frequent with GM-new-SR tablets (2.5% vs 53.4%). CONCLUSION: Treatment with GM-new-SR tablets significantly increased adherence and was associated with improvement in glycemic indices, which could be attributed to the compact shape and size of the new tablet formulation.

Effect of age and Blood Pressure on Surrogate Markers of Atherosclerosis in Patients with Type 2 Diabetes Mellitus.

BACKGROUND: Increased arterial stiffness may be an important path- way linking diabetes mellitus to increased cardiovascular risk. AIM: The study was conducted to assess the surrogate markers of arterial stiffness in patients with Type 2 diabetes mellitus (T2DM), and compare with age-matched hypertensive and healthy controls. Also the effect of age and blood pressure on these markers was evaluated. SETTINGS AND DESIGN: This cross-sectional study was carried out at a tertiary care hospital in West India. METHODS: After a detailed medical history and anthropometric evaluation, all the participants were subjected to measurements of Arterial Stiffness Index (ASI), Pulse Wave Velocity (PWV), and Augmentation Index (AIx) using a non-invasive oscillometric method. The four study groups consisted of patients with T2DM (>5 years) along with hypertension, newly diagnosed patients with T2DM (<2years) without hypertension, hypertensive controls, and healthy controls. RESULTS: PWV, ASI, AIx were elevated in patients with T2DM compared to healthy controls (p<0.05). Patients with T2DM above 60 years had higher carotid-femoral PWV, ASI and AIx than those below 60 years (p<0.05). ASI and AIx were significantly increased in patients with T2DM with hypertension having systolic BP > 140 mmHg compared to those with systolic BP < 140 mmHg. A very strong correlation between PWV and AIx in patients with T2DM and hypertensive controls was observed. CONCLUSION: This study reveals that markers of arterial stiffness (PWV, ASI, AIx) were increased significantly in patients with T2DM compared to healthy controls. Age and systolic blood pressure had significant influence on these markers. Thus, oscillometric markers have potential utility in identifying subclinical atherosclerosis in patients with T2DM.