Effects of taspoglutide on glycemic control and body weight in obese patients with type 2 diabetes (T‐emerge 7 study)

Abstract

Objective: Therapies that lower blood glucose and provide weight loss may provide meaningful benefits for obese patients with type 2 diabetes mellitus (T2DM). This study assessed the efficacy of taspoglutide compared with placebo on glycemic control and weight in obese patients with T2DM inadequately controlled with metformin monotherapy. Design and Methods: In a 24-week, randomized, double-blind, placebo-controlled, multicenter trial, obese adults with T2DM were randomized (1:1) to weekly subcutaneous taspoglutide 20 mg (10 mg for first 4 weeks) (n ¼ 154) or placebo (n ¼ 151) for 24 weeks. Efficacy measures included hemoglobin A1c (HbA1c) levels, body weight, percentage of patients achieving HbA1c 6.5 and 7.0%, and fasting plasma glucose (FPG). Adverse events (AEs) were assessed. Results: Mean baseline HbA1c was 7.55% and mean baseline BMI was 36.7 kg/m 2 . HbA1c reductions from baseline were significantly greater with taspoglutide than placebo (least square mean [LSMean], À0.81% vs. À0.09%; P < 0.0001). Weight loss at week 24 was significantly greater with taspoglutide than placebo (LSMean, À3.16 vs. À1.85 kg; P < 0.01). In the taspoglutide and placebo groups, target HbA1c levels ( 6.5%) were achieved by 49 and 16% of patients, respectively, while 72 and 36% achieved HbA1c levels 7%. Decreases in FPG were significantly greater with taspoglutide than placebo (À23.59 vs. 0.09 mg/dl; P < 0.0001). Nausea and vomiting were the most common AEs associated with taspoglutide, but tended to be transient and generally mild or moderate. Conclusions: In obese patients with T2DM, once-weekly taspoglutide provided the combined benefits of glycemic control and weight loss.

Harnessing glucagon‐like peptide‐1 receptor agonists for the pharmacological treatment of overweight and obesity

“…There are trials examining exenatide in the treatment of obesity; however, evidence supporting the weight‐loss effects of the other GLP‐1RAs relate to trials in T2D in which weight loss was not the primary endpoint. A summary of studies into the effects of GLP‐1RAs on weight loss in participants with and without diabetes is shown in Table .…”

“…These GLP‐1RAs have demonstrated secondary weight benefits in trials in T2D, which were primarily focussed on the assessment of glycaemic control (Table ). Despite the fact that weight loss was not the main focus of the trials presented within Table , statistically significant weight losses were observed with lixisenatide and taspoglutide . Greater weight loss was also observed with albiglutide and dulaglutide vs. placebo, and while these results did not achieve statistical significance, this is likely to reflect study design and smaller treatment groups, rather than lack of effect.…”

The placebo response of injectable GLP‐1 receptor agonists vs. oral DPP‐4 inhibitors and SGLT‐2 inhibitors: a systematic review and meta‐analysis

“…After excluding duplicates and screening references on the basis of title and abstract, 123 relevant references were identified and examined in full text. Sixty‐seven of these publications fulfilled the inclusion criteria and were included in the analysis .…”

“…Of the 67 included RCTs, 18 investigated the efficacy of GLP‐1ra (six examined exenatide , three liraglutide , five lixisenatide , one dulaglutide and three taspoglutide ), 34 examined DPP‐4i (eight sitagliptin , 10 vildagliptin , seven saxagliptin , four alogliptin , five linagliptin ) and 15 researched SGLT‐2i (eight dapagliflozin , four canagliflozin , three empagliflozin ). All included trials were published in English.…”

“…A total of 9840 patients were randomized to placebo treatment in the included trials, 2522 in trials concerning GLP‐1ra, 5290 in trials with DPP‐4i and 2028 for SGLT‐2i. Except for some , most RCTs did not provide details on the appearance and administration of placebo. The study duration was mostly 24 weeks, one study was 52 weeks but reported results on 26 weeks .…”