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Liraglutide safe, effective in black adults with type 2 diabetes
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Black adults with type 2 diabetes assigned the glucagon-like peptide-1 receptor agonist liraglutide for 26 weeks saw a greater reduction in HbA1c and fasting plasma glucose vs. those assigned placebo, with a low incidence of nonsevere hypoglycemia, according to a recent meta-analysis of seven phase 3 studies.
“The African American population shares a significant burden of the risk for diabetes,” Mansur E. Shomali, MD, CM, an endocrinologist at MedStar Union Memorial Hospital in Baltimore and clinical associate and professor of medicine at University of Maryland School of Medicine, told Endocrine Today. “From genetic studies, it is clear that this group is enriched with risk alleles, such as the common variant of TCF7L2. These individuals may harbor resistance to the effects of a GLP-1 [receptor agonist]. In this study, participants with type 2 diabetes who identified themselves as African American or black had an excellent response to the GLP-1 receptor agonist liraglutide. In fact, weight loss, fasting blood glucose lowering and HbA1c reductions were very robust, especially at the 1.8-mg dose.”
Shomali and colleagues pooled and compared patient data from seven randomized phase 3 trials along with placebo data from four of the seven trials (LEAD trials 1-6 and 1860-LIRA-DPP-4 trial; n = 225). Participants were assigned liraglutide (Victoza, Novo Nordisk) 1.2 mg, 1.8 mg or placebo; number of black patients assigned either dose of liraglutide ranged from 9 to 64 across studies. Background therapies varied by trial: no medication (LEAD-3); metformin (LEAD-2 and 1860-LIRA-DPP-4); glimepiride (LEAD-1); metformin and rosiglitazone (LEAD-4); metformin and glimepiride (LEAD-5), and metformin, sulfonylurea or both (LEAD-6); study period was 26 weeks for all studies except LEAD-3 (52 weeks). Efficacy endpoints were change in HbA1c, proportion of patients reaching target HbA1c (7%), and reductions in FPG and body weight. Researchers also assessed reports of nausea and nonsevere hypoglycemia, defined as 56 mg/dL or greater and self-treated.
Black adults assigned 1.2 mg or 1.8 mg liraglutide saw greater reductions in HbA1c at 26 weeks vs. black adults assigned placebo (estimated placebo-adjusted treatment effect size, 1% and 1.3%, respectively; P < .0001 for both). A greater proportion of black adults assigned liraglutide also reached the target HbA1c of 7% vs. black adults assigned placebo (35% and 62% vs. 11%). Black adults also experienced a greater mean reduction in FPG with either dose of liraglutide vs. those assigned placebo (estimated treatment effect sizes, –2.4 mmol/L and –3.1 mmol/L, respectively; P < .0001 when compared with placebo).
Black adults assigned the 1.8-mg liraglutide dose saw a reduction in body weight vs. those assigned placebo (estimated treatment effect size, –2.1 kg; P = .0056), but the estimated treatment effect size was not statistically significant for the 1.2-mg dose (–0.3 kg).
The researchers also noted a difference in body weight change between black and nonblack groups with liraglutide (P = .0355 for interaction between treatment and race).
At 26 weeks, 11.2% of black patients assigned the 1.2-mg dose reported nonsevere hypoglycemia vs. 15% of black adults assigned the 1.8-mg dose and 7.4% of black adults assigned placebo. Black adults assigned liraglutide also reported more adverse gastrointestinal effects vs. those assigned placebo (43.9% and 41% vs. 18.5%, respectively), with the most common reported symptom being nausea (22.4% and 21% vs. 11.1%, respectively). Nausea was primarily reported at initiation and was mild and transient, according to researchers.
“A health care provider should not be treating all patients and expecting them to respond like the average of a group,” Shomali said. “More research is needed on individualizing therapy for chronic diseases in order to select the best drugs which will have the best results for the individual.” – by Regina Schaffer
Disclosure: Novo Nordisk funded this study. One researcher is an employee of Novo Nordisk and holds stock in the company; another researcher is a member of the speakers’ bureaus for GlaxoSmithKline, Janssen, Merck and Novo Nordisk. Shomali reports no relevant financial disclosures.
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