Since Belviq was introduced in June 2013 I have had the opportunity to treat more than 200
patients with Belviq. About 20 of them have diabetes. Surprisingly, the group of
overweight diabetics, some on insulin, some on oral agents and many on no treatment had signficant weight loss and at the same time a lowering of blood sugar and HbA1c of about 1.5. The blood sugar lowering seemed out of proportion to the weight reduction. That is, there was a greater reduction in HbA1c than what one might expect from the weight loss.
Belviq Produces Weight Loss and Improves Glucose Control in Diabetics: The Bloom-Blossom DM Studies
Excess body weight is the main contributor to the development of diabetes type 2. It’s estimated that 85% of diabetics are either overweight (BMI greater than 27) or obese (BMI greater than 30). The first line of therapy for diabetics is diet and exercise. Weight loss of as little as 5% can yield significant improvement in blood sugar control and go a long way in preventing vascular complications and co-morbid conditions. Sadly, diabetics have severe difficulty losing weight and controlling their blood sugars. Weight reduction in diabetics is far more difficult than in non-diabetic overweight people. Current American Diabetic Association treatment guidelines call for a moderate weight loss of 5-7% to improve glucose control and prevent vascular complication.
The Bloom –DM study is the first to evaluate Belviq in patients with well-established diabetes who are taking diabetic medications. The goal was to not only determine the medications' effect on weight loss in this metabolically difficult group, but also to see Belviq’s effect on blood sugar control.
This one-year study examined 604 subjects who were overweight and had diabetes mellitus. They received 10 mg of Lorcaserin once or twice daily. Average starting weight was 236 lbs and mean HbA1C was 8%. Thirty seven percent of subjects lost at least 5% of their body weight, and 16% lost at least 10% of their initial body weight. Half of the subjects taking Belviq achieved the recommended HBA1c level of less than 7%, almost twice seen in the placebo group. The weight reduction was seen at two weeks and persisted throughout the study.
No Belviq related adverse side effects were observed in this study. Cardiac ECHO studies showed no valvular damage. The authors of the study emphasized the significant improvement in glycemic control with the drug. An interesting observation was the fact the improvement in glucose control with Belviq and weight loss was very similar to that seen when anti-diabetic agents are used alone for control of blood sugar. Note these subjects were already taking Glycemic agents.
Actual abstract of Bloom -DM Study:
reference of Bloom Blossom DM Study
Obesity (Silver Spring). 2012 Jul;20(7):1426-36. doi: 10.1038/oby.2012.66. Epub 2012 Mar 16.
Randomized placebo-controlled clinical trial of lorcaserin for weight loss in type 2 diabetes mellitus: the BLOOM-DM study.
Weight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
The BLOOM-DM (Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus) study evaluated efficacy and safety of lorcaserin for weight loss in patients with type 2 diabetes. Secondary objectives included evaluations of glycemic control, lipids, blood pressure, and quality of life. This 1-year, randomized, placebo-controlled trial enrolled 604 patients 1:1:1 to placebo, lorcaserin 10 mg once daily (QD) or lorcaserin 10 mg twice daily (BID). Patients were treated with metformin, a sulfonylurea (SFU) or both; had glycated hemoglobin (HbA(1c)) 7-10%; were 18-65 years old; and had BMI 27-45 kg/m(2). Patients received diet and exercise counseling. Safety monitoring included serial echocardiograms. Mean (± SD) age was 52.7 ± 8.7; 54.2% were women; 60.5% were white, 20.9% were African American, and 13.8% were Hispanic. Mean (± SD) weight was 103.6 ± 17.8 kg; BMI was 36.0 ± 4.5 kg/m(2). Most patients (91.7%) took metformin; 50.2% took a SFU. More patients lost ≥5% body weight with lorcaserin BID (37.5%; P < 0.001) or lorcaserin QD (44.7%; P < 0.001) vs. placebo (16.1%; modified intent to treat (MITT)/last observation carried forward (LOCF)). Least square mean (± SEM) weight change was -4.5 ± 0.35% with lorcaserin BID and -5.0 ± 0.5% with lorcaserin QD vs. -1.5 ± 0.36% with placebo (P < 0.001 for each). HbA(1c) decreased 0.9 ± 0.06 with lorcaserin BID, 1.0 ± 0.09 with lorcaserin QD, and 0.4 ± 0.06 with placebo (P < 0.001 for each); fasting glucose decreased 27.4 ± 2.5 mg/dl, -28.4 ± 3.8 mg/dl, and 11.9 ± 2.5 mg/dl, respectively (P < 0.001 for each). Symptomatic hypoglycemia occurred in 7.4% of patients on lorcaserin BID, 10.5% on lorcaserin QD, and 6.3% on placebo. Common adverse events were headache, back pain, nasopharyngitis, and nausea. Lorcaserin was associated with significant weight loss and improvement in glycemic control in patients with type 2 diabetes.