Molecular Mechanisms Linking Oxidative Stress and Diabetes Mellitus

Table 1

Clinical trials undertaken with anti-inflammatory agents.

Study population	Study design	Treatment	Dose	Results	Ref.
81 patients with T2DM	Randomized double-blind placebo-controlled trial	Salsalate	3.0, 3.5, or 4.0 g/d for 14 weeks	Reduced the HbA1c and FBG	[117]
20 obese nondiabetic adults	Randomized double-blind placebo-controlled trial	Salsalate	4.0 g/day for 4 weeks	Declined FBG, HbA1c, and C-peptide and increased adiponectin	[118]
70 patients with T2DM	Randomized double-blind placebo-controlled trial	Anakinra, a recombinant human IL-1R	13 weeks	Alleviated inflammatory markers and improved glucose control even after treatment withdrawal	[119]
15 patients with T2DM	Open-label trial^a and randomized double-blind placebo-controlled trial^b	Salsalate	3 and 4.5 g/d for 2 weeks	Improved glucose control, circulating free fatty acid, and adiponectin levels	[118]
286 patients with T2DM	Randomized double-blind placebo-controlled trial	Salsalate	3.5 g/d for 48 weeks	Reduced mean HbA1c	[120]
257 patients with T2DM	Randomized double-blind placebo-controlled trial	Salsalate	3.5 g/d for 30 months	Reduced inflammatory markers and FBG	[121]
7,000 patients with MI and insulin resistance	Randomized double-blind placebo-controlled trial	Methotrexate	15-20 mg/wk for 3-5 years	Reduced inflammatory markers and HbA1c	[122]

Anakinra: a recombinant human IL-1 receptor; FBG: fasting blood glucose; HbA_1c: glycated hemoglobin; MI: myocardial infarction. ^aTwo studies with open-label design at doses of 3 and 4.5 g/day. ^bOne study with a randomized double-blind placebo-controlled design.