Publication: Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide.
No Thumbnail Available
Identifiers
Date
2019-07-18
Authors
Rosenstock, Julio
Sorli, Christopher H
Trautmann, Michael E
Morales, Cristóbal
Wendisch, Ulrich
Dailey, George
Hompesch, Marcus
Choi, In Young
Kang, Jahoon
Stewart, John
Advisors
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
To explore the efficacy, safety, and tolerability of once-weekly efpeglenatide, a long-acting glucagon-like peptide 1 receptor agonist (GLP-1 RA), in early type 2 diabetes (T2D) (drug naive or on metformin monotherapy). EXCEED 203 was a 12-week, randomized, placebo-controlled, double-blind, parallel-group, dose-ranging study of efpeglenatide once weekly referenced to open-label liraglutide 1.8 mg (exploratory analysis). Participants, ∼90% on metformin monotherapy, were randomized to one of five efpeglenatide doses (0.3, 1, 2, 3, or 4 mg q.w.; n = 181), placebo (n = 37), or liraglutide (≤1.8 mg daily; n = 36). The primary efficacy end point was change in HbA1c from baseline to week 13. From a baseline HbA1c of 7.7-8.0% (61.0-63.9 mmol/mol), all efpeglenatide doses ≥1 mg significantly reduced HbA1c versus placebo (placebo-adjusted least squares [LS] mean changes 0.6-1.2%, P Efpeglenatide once weekly led to significant reductions in HbA1c and weight, with a safety profile consistent with the GLP-1 RA class in patients with early T2D mostly on metformin monotherapy.
Description
MeSH Terms
Adult
Aged
Blood Glucose
Body Weight
Diabetes Mellitus, Type 2
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Female
Glucagon-Like Peptide-1 Receptor
Glycated Hemoglobin
Humans
Hypoglycemic Agents
Liraglutide
Male
Metformin
Middle Aged
Proline
Treatment Outcome
Aged
Blood Glucose
Body Weight
Diabetes Mellitus, Type 2
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Female
Glucagon-Like Peptide-1 Receptor
Glycated Hemoglobin
Humans
Hypoglycemic Agents
Liraglutide
Male
Metformin
Middle Aged
Proline
Treatment Outcome