A CLINICAL STUDY ON ADVERSE DRUG REACTIONS OF COMBINATION THERAPY OF DAPAGLIFLOZIN AND METFORMIN IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS


Syed Safiullah Ghori, Amit Kapoor

Abstract


ABSTRACT
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 β-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
consistent trend.
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.


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About this article

Title

A CLINICAL STUDY ON ADVERSE DRUG REACTIONS OF COMBINATION THERAPY OF DAPAGLIFLOZIN AND METFORMIN IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS

DOI

10.22159/ajpcr.2017.v10i3.16380

Date

01-03-2017

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 10 Issue 3 March 2017 Page: 406-408

Print ISSN

0974-2441

Online ISSN

2455-3891

Statistics

76 Views | 99 Downloads

Authors & Affiliations

Syed Safiullah Ghori
Anwarulaloom College of pharmacy Mallepally,Hyderabad-500001
India

Amit Kapoor


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