EVALUATION OF EFFICACY AND SAFETY OF FDC OF THREE ANTIDIABETIC DRUGS VERSUS FDC OF TWO ANTIDIABETIC DRUGS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES: AN OPEN LABEL, RANDOMIZED, COMPARATIVE, MULTICENTRIC STUDY

Efficacy and safety of FDC of Glimepiride, Voglibose and Metformin ER was determined in open label, randomized, comparative, multicentric, 29 weeks study (1 week of screening period, 4 weeks of run-in period and 24 weeks of treatment period) in 294 patients at 11 different centers across India. Patients with type 2 diabetes and fulfilling all the inclusion criteria were enrolled in the study. Two groups of patients who were      receiving either fixed dose combination of Glimepiride 1 mg + Metformin ER 500              mg or fixed dose combination of Glimepiride 2 mg + Metformin ER 500 mg two times  daily dose and met all inclusion the criteria and none of the exclusion criteria at  screeningvisit were considered eligible for “Run-in Period†in the study.

Patients were kept  on  same  dose  (of screening)  for  4  weeks  in  run  in  period  after successful screening and both the groups of patients were reevaluated for eligibility criteria after 28 days.   Patients who met all the inclusion criteria and none of exclusion criteria were enrolled in the study and randomized to either dual drug therapy or triple drug therapy.The dose was taken just before meal or with the first bite of each main     meal. Patients on Glimepiride 1 mg + Metformin ER 500 mg twice daily group during “Run-in Period†were randomized when eligible to either receive Glimepiride 1 mg + Metformin ER 1000 mg twice daily or Glimepiride 1 mg + Voglibose 0.2 mg + Metformin ER 500 mg twice daily for 24 weeks. Patients on Glimepiride 2 mg + Metformin ER 500 mg twice daily group during â€œRun in Period†were randomized when eligible to either receive Glimepiride 2 mg + Metformin ER 1000 mg twice daily or Glimepiride 2 mg + Voglibose 0.2 mg + Metformin ER 500 mg twice daily for 24 weeks. Primary efficacy variables were Change in PPBG from baseline and Change in HbA1c from baseline. Secondary efficacy variables were Change in FBG from baseline, Proportion of participants with HbA1c reduction of at least 1% at the end of 24 weeks, Proportion of participants with PPBG < 170 mg/dl at the end of 24 weeks and evaluation of Clinical Global Impression on Improvement (CGI-I).

In summary, based on the study results, it is concluded that FDC of three drugs (FDC of Glimepiride 1mg + Voglibose 0.2 mg + Metformin ER 500 mg group and FDC of Glimepiride 2 mg + Voglibose 0.2 mg + Metformin ER 500 mg group) is safe and effective in patients with type 2 DM. It is especially useful in Indians, because of higher pancreatic beta-cell function, less insulin sensitive and consumption of carbohydrate as polished rice. It can also be an alternative for elderly patients and in those with hepatic impairment or mild to moderate renal function impairments in whom further increase in Metformin dose is not recommended.