The Number of Participants:- The sample size required to detect a minimum clinical significant difference of 27.7% in those achieving the primary outcome between the treatment arms is 116 participants (n=58 per group), with 80% power and an alpha of 5%, assuming a dropout rate of 20%. This is based on 21.2% of the SU plus metformin group in the 'Treat 4 Ramadan study' having met the proposed primary outcome of achieving the double composite endpoint of a reduction in HbA1c (≥0.3%) and weight loss (≥ 1kg) 3-4 weeks post-Ramadan.