Table 2

Categories of comparator arms in 42 published and unpublished clinical trials of metformin FDCs in patients with type 2 diabetes.

Metformin FDCPublished/
Unpublished
Categories of comparator arms
FDC vs concomitant SDFs* FDC vs monotherapy†FDC vs other‡FDC vs FDC§Other¶Experimental vs marketed**
Glimepiride
CDSCO approval 2002
Published012000
Unpublished051††3††31
Glimepiride/Pioglitazone
CDSCO approval 2005
Published001010
Unpublished003††2††00
Glipizide
CDSCO approval 1998
Published010000
Unpublished000000
Glibenclamide
CDSCO approval 1995
Published18††67††01
Unpublished011000
Gliclazide
CDSCO approval 2005
Published000000
Unpublished000000
  • Online supplementary tables 3 and 4 provide details of the unpublished trials.

  • *FDC versus concomitant SDFs=FDC versus concomitant treatment with the FDC components given as SDFs.

  • †FDC versus monotherapy=FDC versus metformin and/or sulfonylurea monotherapy.

  • ‡FDC versus other=FDC versus a different FDC combination or concomitant treatment.

  • §FDC versus FDC=same FDC components but comparing different dosages or formulations.

  • Other=same FDC but under different trial conditions, for example, fed versus fasting conditions.

  • **Experimental versus marketed=experimental (new) FDC versus previously marketed FDC.

  • ††Trials (7) with multiple comparator arm categories in the same study.

  • CDSCO, Central Drugs Standard Control Organization; FDC, fixed-dose combinations; SDF, single-drug formulations.