A randomized double-blind clinical trial of fluoxetine in obese diabetics

Abstract

Fluoxetine is an inhibitor of serotonin re-uptake which has been found to produce weight loss in humans and animals. To test the effects of this drug in obese diabetic subjects, 48 male and female, obese type II non-insulin dependent (NIDDM) diabetics who were being treated with insulin were randomized to receive either fluoxetine 60 mg or a placebo once daily in a randomized double-blind fashion for 24 weeks. A four week single-blind placebo lead-in period preceded and a six week single-blind placebo period followed the double-blind treatment period. Subjects performed daily home glucose monitoring and were given instruction in a 1200kcal American Diabetic Association (ADA) diet. Subjects treated with fluoxetine achieved a maximum 8 kg greater weight loss on average than the placebo-treated subjects. At the end of active treatment, fluoxetine-treated subjects had significantly lower glycohaemoglobin levels than the placebo-treated group (9.72 vs. 10.76%, P < 0.05). In addition, fluoxetine-treated subjects showed a greater decrease in total daily insulin dose than placebo-treated subjects (44.5 vs. 20.1% decrease at the end of active treatment, P < 0.05). These results suggest that fluoxetine may be of benefit in the treatment of obese patients with type II non-insulin dependent diabetes mellitus.