4 • Probe •Vol LXII • No. 4 • Sep–Dec 2023 Clinical Evidence 1 Efficacy and Safety of Diabecon® in the Management of Non–Insulin-Dependent Diabetes Mellitus Aim To assess the efficacy and safety of Diabecon as a monotherapy and as an adjuvant with other oral hypoglycemic agents (OHAs) in the management of non–insulin-dependent diabetes mellitus (NIDDM) Materials and Methods This prospective, open, nonrandomized phase 3 trial included 50 patients of either sex (aged 30–60 y) who were diagnosed with NIDDM, and who were willing to give informed consent. Patients with insulin-dependent diabetes mellitus; those with NIDDM having acute complications of diabetes; patients with severe hypertension, myocardial infarction, cerebral vascular accident, renal failure, and a history of severe unstable angina; pregnant and lactating women; and patients who were not willing to give informed consent were excluded from the study. The patients were categorized into 2 groups (25 in each): group 1 had patients with recently diagnosed NIDDM who were not consuming any OHA, and group 2 had patients with NIDDM who were consuming OHAs. All patients were instructed to take 2 tablets of Diabecon, BID, for 3 months. The blood sugar level (BSL) was analyzed in each patient at the time of enrollment and every month for 3 months. All patients underwent biochemical laboratory examinations (hemogram; total leukocyte count; differential leukocyte count; blood urea; serum creatinine, albumin, and globulin levels; and lipid profile). The improvement in the NIDDM symptoms was evaluated using a predefined symptom score scale ranging from 0 to 3 (0, absent; 1, mild; 2, moderate; and 3, severe). The predefined primary end points were postprandial blood sugar level (PPBSL) control and reduction in the dose of other OHAs. The PPBSL control was graded as “excellent” (up to 130 mg%), “good” (up to 150 mg%), “fair” (up to 180 mg%), “poor” (up to 250 mg%), and “treatment failure” (> 250 mg%). The secondary end points were a reduction in the incidence of adverse reactions and overall compliance to the drug. All patients were followed up for 3 months, and response to Diabecon, subjective symptomatic relief, and changes in the symptom score for each symptom were recorded during each follow-up visit. Results In group 1, the fasting blood sugar level (FBSL) and PPBSL were significantly reduced by the third month. The FBSL reduced from 170 ± 40.47 to 161.51 ± 52.13 mg%, and the PPBSL reduced from 247.66 ± 70.65 to 223.13 ± 79.22 mg% (Figure 1). Group 2 patients experienced a significantly higher reduction in FBSL after 1 month (from 174.69 ± 55.77 to 148.66 ± 35.49 mg%), and it was further reduced to 145.40 ± 39.43 mg% by the end of the study (Figure 2). Overall, in both the groups, there were significant improvements in NIDDM symptoms such as polyuria and generalized weakness, and there was also an improvement in appetite. After 1 month of treatment, there was a significant reduction in leg cramps
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