ResearchPad - clinical-trials-and-investigations Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Efficacy and Safety of Ertugliflozin in Patients with Overweight and Obesity with Type 2 Diabetes Mellitus]]> This study aimed to evaluate ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus.MethodsData from three placebo‐controlled, randomized, Phase 3 studies were pooled. Patients with baseline BMI ≥ 25 (1,377/1,544; 89%) were assessed with a stratification by BMI subgroup.ResultsAt week 26, reductions from baseline in glycated hemoglobin A1c (HbA1c), fasting plasma glucose, body weight (BW), and systolic blood pressure (SBP) were greater with ertugliflozin versus placebo. For placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively, least squares mean change was 0.1%, −0.8%, and −0.9% for HbA1c and −1.2 kg, −3.1 kg, and −3.2 kg for BW. HbA1c reductions were consistent across BMI subgroups. For ertugliflozin 5 mg and 15 mg, least squares mean change (placebo adjusted) in absolute BW was −1.4 kg and −1.2 kg for BMI 25 to < 30, −1.8 kg and −1.9 kg for BMI 30 to < 35, and −2.5 kg and −2.9 kg for BMI ≥ 35. Percent BW changes were similar across BMI subgroups. Incidence of adverse events was 52.5%, 44.6%, and 50.1% with placebo, ertugliflozin 5 mg, and ertugliflozin 15 mg, respectively.ConclusionsMeaningful reductions in HbA1c, fasting plasma glucose, BW, and SBP were observed with ertugliflozin in patients with overweight and obesity with type 2 diabetes mellitus. Ertugliflozin improved HbA1c and SBP and reduced BW across BMI subgroups. Ertugliflozin was generally well tolerated. ]]> <![CDATA[Licogliflozin, a Novel SGLT1 and 2 Inhibitor: Body Weight Effects in a Randomized Trial in Adults with Overweight or Obesity]]> The aim of this study was to explore the dose response of licogliflozin, a dual inhibitor of sodium/glucose cotransporter 1 (SGLT1) and 2 (SGLT2), by evaluating change in body weight in adults with overweight or obesity.MethodsThis dose‐response analysis evaluated change in body weight following 24 weeks with four once‐daily and twice‐daily licogliflozin doses (2.5‐150 mg) versus placebo (primary end point). A further 24‐week analysis evaluated the efficacy and safety of two once‐daily licogliflozin doses in maintaining initial weight reduction.ResultsLicogliflozin once daily or twice daily produced a significant dose‐response signal for weight loss versus placebo (P < 0.0001). However, mean adjusted percent changes in body weight after 24 weeks were modest, ranging from −0.45% to −3.83% (in the 50 mg twice daily group [95% CI: −5.26% to −2.48%]; n = 75). Responder analysis of ≥ 5% weight loss at week 24 revealed significant differences versus placebo, which were most pronounced with highest doses of 50 mg twice daily (45.3%) and 150 mg once daily (42.9%) (both P < 0.01). While weight loss was greater at higher doses, gastrointestinal adverse events were also more frequent. The 50‐mg once‐daily dose had perhaps the best balance between efficacy and tolerability.ConclusionsLicogliflozin produced significant reductions in body weight versus placebo. However, the magnitude of weight reduction was modest. ]]>