EFFICACY AND SAFETY OF VILDAGLIPTIN AND TENELIGLIPTIN IN PATIENTS OF TYPE 2 DIABETS MELLITUS INADEQUATELY CONTROLLED ON STABLE DOSES OF METFORMINAbstract
This was a 24-week, randomized, open label study. Treatment-naive patients diagnosed with Type 2 diabetes mellitus were randomized into two groups, Group-1 (Vildagliptin 50 mg, twice dailyplus Metformin 500 mg, twice daily) and Group-2 (Teneligliptin 20 mg, once dailyplus Metformin 500 mg, twice daily). The primary objective was to compare fasting plasma blood glucose levels (FBG), 2-h post prandial blood glucose levels (2-h PPG) and HbA1c reduction from baseline in both the groups at the week 24 endpoint. From comparable baseline values HbA1c decreased in both treatment groups, to the greater extent with teneligliptin plus metformin combination therapy. Reductions in FPG were superior with teneligliptin plus metformin combination therapy [change from baseline -38.63 mg/dL] (p>0.05). Reductions in 2-h PPG were also superior with teneligliptin plus metformin combination therapy [change from baseline -37.85 mg/dL] (p>0.05). There was no incidence of hypoglycemia with either combination therapy. Efficacy and Safety of Teneligliptin over a period of 24 weeks was comparable to that of vildagliptin when given with stable doses of Metformin.
N. Rizvi, J. Ahmad *, F. Ahmad and S. S. Siddiqui
Department of Pharmacology, J. N. Medical College, AMU Aligarh, Uttar Pradesh, India.
25 May 2019
28 October 2019
30 November 2019
01 April 2020