Clinical evaluation of sibutramine in obese type 2 diabetic patients refractory to dietary management.
METHODS
An open, non-comparative study was carried out to assess the efficacy and toleration profile of sibutramine, a new antiobesity drug, in promoting weight loss in obese type 2 diabetes mellitus subject who failed to reduce weight after strict dietary control. Twenty seven patients completed the study. Sibutramine was started as a single morning dose of 10 mg and was subsequently increased to 15 mg daily if weight loss was not satisfactory. The total duration of the study was twelve weeks with followup at every four weeks. Effect of drug was monitored in terms of weight reduction, changes in body mass index, waist circumference, hip circumference, waist/hip ratio and other metabolic parameters. A fixed dietary prescription and concomitant therapy with drugs, if required and not likely to interfere with the trial therapy, was permitted but was not changed during the study period.


RESULTS
At the end of 12 week, mean weight reduction in study subjects was 4.16 kg (p < 0.001), the corresponding BMI decreased by 1.6 (p < 0.0001) and hip circumference by 3.68 (p < 0.001). However, there was no significant change in fasting blood glucose and Hb(A1c) values.


CONCLUSIONS
The study indicates sibutramine to be an effective and well tolerated agent leading to significant reduction in parameter of obesity in obese type 2 diabetic subjects.
Sircar
A R
AR
Department of Medicine, KG's Medical College, Lucknow.
Kumar
A
A
Lal
M
M
D000328:Adult; D000368:Aged; D001067:Appetite Depressants / Q000008:administration & dosage*; D003503:Cyclobutanes / Q000008:administration & dosage*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications* / Q000175:diagnosis; D018752:Diet, Fat-Restricted; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000150:complications* / Q000188:drug therapy*; D011446:Prospective Studies; D017211:Treatment Failure; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
D001067:Appetite Depressants; D003503:Cyclobutanes; C058254:sibutramine