In this trial, 821 patients who had previously used only Metformin and/or a sulfonylurea were placed on (only) Metformin plus Victoza 1.8mg. Of these, 498 patients were able to reach their A1c goal during the 12-week run-in, and were placed into an Observational group. Three hundred twenty-three patients did not reach their A1c goal and were randomly placed into groups that continued Metformin plus Victoza or that added Levemir to Metformin plus Victoza for an additional 26 weeks.
On average, patients in both these randomized groups continued to see A1c reductions, with much greater A1c reduction in the Levemir group. Additionally, patients in both Randomized groups on average continued to lose body weight at rates comparable to the patients in the Observational group; however, the most overall weight loss for all groups occurred during the run-in, when only Metformin plus Victoza was given to all the study participants.
Reports of minor hypoglycemic events were low in all groups, with the highest rate occurring in the Levemir-added group at less than 1 event/patient/year; there were no reported major hypoglycemic events. Transient nausea was reported at a rate of 21% of all participants during the 12-week run-in period, falling to a 4% rate overall during the 26-week main study period. In summary, the novel sequence of therapy used in this study showed itself to be safe and well-tolerated. Of note are the findings for the Observational group, which had the largest average A1c reduction (1.34%), while starting with the lowest average starting A1c (7.7%). This may imply that patients who respond well to Metformin therapy and are relatively close to goal might make excellent candidates for the addition of Victoza. For those patients still above goal, the addition of Levemir appears to be an effective therapeutic choice.
Liraglutide Shows Potential as Treatment for Weight Loss
Recent obesity studies have focused on anti-diabetic agents that would not only help control glucose levels, but also allow patients to drop a few pounds.
The SCALE study reported on at the ADA conference, assessed the effectiveness of liraglutide, in maintaining or promoting further weight loss in overweight or obese type 2 diabetic patients. The trial was 56 weeks in duration with an additional 4-12 week lead in period in which patients were to lose at least 5% of their body weight. After the lead in period the patients were randomized to liraglutide or placebo for the duration of the study. The primary outcomes of the study included the proportion of patients that maintained the lead in weight loss, those that lost more weight, and those that lost 5% or more of their body weight at randomization.
The results were pleasing -- 81% of patients on liraglutide maintained the lead in weight loss compared to 49% of patients on placebo. Liraglutide also induced an additional average weight loss of 6.1% on top of the lead in weight loss. The majority of patients lost at least 5% and there was no further weight loss effect seen in the placebo group. The adverse effects reported were comparable between the groups, and the most common complaint with liraglutide was nausea, which is thought to diminish after titration of the medication.
All in all liraglutide looks like it could be a promising agent in the realm of weight loss potentially due to its satiation effects. The SCALE study (Satiety and Clinical Adiposity -- Liraglutide Evidence in Non-Diabetic and Diabetic Subjects) opens the door as a potential weight loss remedy in not only the diabetic community, but in non-diabetics as well. Keep in mind, these patients had greater incidence of visceral fat, which often leads to diabetes, so these results may not work the same for 'fit' overweight or obese patients.
Eric Nielsen, PharmD Candidate, University of Florida College of Pharmacy
Tiffany Beckel, PharmD Candidate, University of Florida College of Pharmacy