A CLINICAL STUDY ON ADVERSE DRUG REACTIONS OF COMBINATION THERAPY OF DAPAGLIFLOZIN AND METFORMIN IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS
Objective: This study aimed at determination of safety and efficacy of combination therapy of dapagliflozin and metformin in the treatment of Type
2 diabetes mellitus.
Methods: A total of 50 patients were enrolled in the study depending on demographic parameters and clinical data of the patients. The primary
efficacy criterion was the change in glycated hemoglobin (HbA1c) after a minimum of 12 weeks of treatment. Secondary efficacy parameters were
HbA1c value after 12 weeks, fasting and 1 hrs postprandial glucose, serum insulin and triglyceride levels, after a standardized meal, all after 12 weeks
of treatment. Safety and tolerability were evaluated by the incidence of adverse events reported by patients. Patient visits to the clinical center were
scheduled at screening, start of the run-in period.
Results: Reductions in levels of postprandial plasma glucose were observed in all the active treatment groups. The reductions in patients receiving
metformin plus dapagliflozin combination therapy were significantly greater (p<0.0001). It was clear that lower postprandial plasma insulin levels
despite higher postprandial plasma glucose levels suggest decreased Î²-cell function. Changes in fasting serum insulin observed from baseline to the
end of treatment did not differ significantly between metformin plus dapagliflozin combination therapy and metformin monotherapy and showed no
Conclusion: The results from the study suggest that the combination of the drugs was effective in controlling glycemic levels and also were safe. No
serious adverse drug reactions were reported by the patients when used daily once for 6 months.
Keywords: Dapagliflozin, Metformin, Postprandial and glycemic.
Pan CY, Gao Y, Chen JW, Luo BY, Fu ZZ, Lu JM, et al. Efficacy of acarbose in Chinese subjects with impaired glucose tolerance. Diabetes Res Clin Pract 2003;61(3):183-90.
Alberti KG, Zimmer PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: Diagnosis and classification of diabetes mellitus, provisional report of a WHO consultation. Diabet Med 1998;15:539-53.
Martha S, Kennedy N. Pancreatic hormones and anti diabetic drugs. In: Basic and Clinical Pharmacology. Vol. 9. New York, NY: McGraw-Hill Co.; 2004. p. 693-715.
Rang HP, Dale MM. The endocrine pancrease and the control of blood glucose in pharmacology. Vol. 5. Edinburgh: Churchill Livingstone; 2003. p. 380-93.
Jermendy G. Can type 2 diabetes mellitus beconsider preventable? Diabetes Res Clin Pract 2004;68:73-81.
Powers AC. Diabetes mellitus. In: Harrisonâ€™s Principle of Internal Medicine. Vol. 16: 2001. p. 2114-5.
IDF. Diabetes Atlas. 4th ed. Belgium: International Diabetes Federation; 2009.
Markus RU. Alpha glucosidase inhibitor in thetreatment of diabetes mellitus. In: Diabetes Mellitus: A Fundamental and Clinical Text. Vol. 3. Philadelphia, PA: Lippincott Williams & Wilkins; 2004. p. 115-1159.
Hanefeld M, Cagatay M, Petrowitsch T, Neuser D, Petzinna D, Rupp M. Acarbose reduces the risk for myocardial infarction in type 2 diabetic patients: Meta analysis of seven long term studies. Eur Heart J 2004;24(1):10-6.
Basevi V, Di Mario S, Morciano C, Nonino F, Magrini N. Comment on: American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care 2011;34 Suppl 1:S11-61.
John R, Buse B. Management of type 2 diabetes mellitus in cecil. Essentials Med 2001;5:1231-46.
Nayak BS, Bhaktha G. Inconsistent lipid profiles exhibited among the diabetic Asian Indians of India and Trinidad - A comparative study. Int J Pharm Pharm Sci 2016;8(12):60-3.
Ritonga RH, Suprapti B, Khatib J. The influence of sodium orthovanadate on p85 and gsk-3 expressions to the blood glucose regulation of type 2 diabetic mice (Mus musculus) model. Int J Pharm Pharm Sci 2015;7(1):115-9.
Howard BV, Howard WJ. Pathophysiology and treatment of lipid disorders indiabetes. Diabetes Mellitus 2005;14: 563-79.
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