Sadly, Professor Sachse passed away following the completion of this manuscript.
The effects of orlistat on body weight and glycaemic control in overweight patients with type 2 diabetes: a randomized, placebo-controlled trial
Version of Record online: 30 OCT 2002
Diabetes, Obesity and Metabolism
Volume 4, Issue 6, pages 415–423, November 2002
How to Cite
Hanefeld, M. and Sachse, G. (2002), The effects of orlistat on body weight and glycaemic control in overweight patients with type 2 diabetes: a randomized, placebo-controlled trial. Diabetes, Obesity and Metabolism, 4: 415–423. doi: 10.1046/j.1463-1326.2002.00237.x
- Issue online: 30 OCT 2002
- Version of Record online: 30 OCT 2002
- Received 3 July 2002; accepted 5 July 2002
- type 2 diabetes;
- glycaemic control;
- haemoglobin A1C
Aim: To assess the long-term effects of orlistat on body weight, glycaemic control and cardiovascular risk factors in overweight patients with type 2 diabetes.
Methods: This was a multicentre, randomized, placebo-controlled study with a 4-week placebo plus diet lead-in period and a 48-week, double-blind treatment period. Overweight or obese adults [body mass index (BMI) ≥ 28 kg/m2] with HbA1c of 6.5–11% and clinical type 2 diabetes were randomized to orlistat (120 mg t.i.d. n = 189) or placebo (n = 180) in conjunction with a low-calorie diet. Patients had either received sulphonylurea therapy for at least 2 months before the study or were not receiving any antidiabetic medication (the majority of which were drug-naïve).
Results: After 1 year, patients in the orlistat group lost significantly more weight than patients in the placebo group (−5.4% vs. −3.6%; p = 0.006). Moreover, significantly more patients achieved weight loss of ≥ 5% with orlistat compared with placebo (51.3% vs. 31.6%; p = 0.0001). Patients treated with orlistat also had significantly greater improvements than placebo-treated patients in HbA1c (−0.9% vs. –0.4%; p < 0.001), fasting glucose (−1.6 vs.–0.7 mmol/l; p = 0.004) and post-prandial glucose (−1.8 vs. –0.5 mmol/l; p = 0.003). In addition, orlistat-treated patients had a significantly greater reduction in LDL cholesterol compared with placebo. Overall, orlistat had a similar safety profile to placebo, with the exception of a higher incidence of generally mild and transient gastrointestinal events known to be associated with the mode of action of orlistat.
Conclusions: Treatment with orlistat plus diet resulted in significant weight loss, improved glycaemic control and cardiovascular risk factor profile in overweight patients with type 2 diabetes.