WCTD2016 Abstract Topics Meta-Analysis of Phase 2/3 Studies (3 abstracts)
Cohort Analysis of Randomized Clinical Trials on long acting GLP-1 receptor agonists versus DPP4 inhibitors
Thuy Pham <strong>1</strong>, , Mukunda Singh 1, , Marvin Dao 1, , Griselda Herrera 3 & Katherine Asuncion 4
1Clinical Trials, Clinical Trial Network, Houston, TX, USA; 2College of Medicine, Windsor University College of Medicine, Saint Kitts and Nevis; 3Nursing, Houston Community College, Houston, TX, USA; 4Pediatrics, Clinical Trial Network, Houston, TX, USA.
Background: Oral semaglutide GLP1 receptor agonist is coformulated for better absorption compared to prior injectable semaglutide. Phase 2 open label, dose escalation randomized clinical trials of semaglutide and liraglutide investigating the dose-response relationship between the two. DPP-4 inhibitor produces a smaller glycemic reduction and minimal weight reduction through effect of endogenous GLP-1 receptor activity, while GLP-1RAs yield greater efficacy related to the pharmacological levels of these agonists stimulating GLP-1 receptor activity.
| Design & Methods | Objective | IND | Treatment Arms | Endpoints | Results & Conclusions |
| Phase 2 RCT placebo controlled dose findings | Dose Findings Analysis of Oral Semaglutide | Oral Semaglutide or Placebo | 2.5 mg QD/ Placebo; 5.0 mg QD/ Placebo, 10 mg QD/ Placebo; 20 mg QD/ Placebo; 40 mg QD/ Placebo | Changes in HbAlc in 26 weeks: Weight Reduction | HbAlc mean 7.9%; 2 to 7 kg Weight reduction |
| Phase 2 RCT with Dose Escalation | To investigate the dose-response relationship of semaglutide versus placebo and open-label liraglutide in terms of glycemic control in patients with type 2 diabetes | Injectable Semaglutide | 0.1 to 0.8 mg QW with dose escalation 0.4 to 0.8 mg; 1.6 mg for 1–2 weeks | Changes in HbAlc in 12 weeks: Weight Reduction | 1.7% HbAlc reduction; 4.8 kg weight reduction; (1.6 mgE. P< 0.001 vs Placebo) |
| Oral Liraglutide | 1.2 or 1.8 mg/Placebo | ||||
| RCT DPP4 Inhibitor to switch GLP 1 after 52 weeks Metformin | To assess the efficacy and safety of switching from sitagliptin to liraglutide in metformin- treated adults with type 2 diabetes | Sitagliptin; Liraglutide; Metformin | 100 mg QD+ Metformin; 1.2 or 1.8 mg QD + Metformin | Changes in HgAlc in 52 weeks; Weight reduction | 0.9% HbAlc reduction Sitagliptin; 1.35 HbAlC reduction Liraglutide, 2.6 kg Weight reduction for Sitagliptin; 3.1 kg Weight reduction for Liraglutide |
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