Diabetes, obesity & metabolismJul 8, 2017

How well and how safely a new once-weekly self-injected exenatide works compared to twice-daily exenatide in type 2 diabetes

GLP-1 Therapies Weekly Brief ↗PubMed ↗DOI ↗OA ↗

Updated Apr 6, 2026

Abstract

In a study of 375 patients with type 2 diabetes, exenatide QWS-AI reduced HbA1c by -1.4% compared to -1.0% with exenatide BID.

Exenatide QWS-AI resulted in a statistically significant greater reduction in HbA1c than exenatide BID (least-squares mean difference, -0.37%; P = .0072).
A higher percentage of patients achieved HbA1c levels below 7.0% with exenatide QWS-AI (49.3%) compared to exenatide BID (43.2%), although this difference was not statistically significant (P = .225).
Both treatment groups experienced weight loss, but the difference in weight reduction between the groups was not significant (P = .37).
Gastrointestinal adverse events occurred in 22.7% of patients using exenatide QWS-AI, compared to 35.6% in the exenatide BID group.
Fewer patients in the exenatide QWS-AI group withdrew from the study due to adverse events compared to the exenatide BID group.
Minor hypoglycaemia was more common among patients using sulfonylureas in conjunction with either treatment.

Simplified

AIMS: To simplify administration of aqueous exenatide once weekly, which requires reconstitution, the exenatide microspheres have been reformulated in a ready-to-use autoinjector with a Miglyol diluent (exenatide QWS-AI). This study compared the efficacy and safety of exenatide QWS-AI with the first-in-class glucagon-like peptide-1 receptor agonist exenatide twice daily (BID).

MATERIALS AND METHODS: This randomized, open-label, controlled study in patients with type 2 diabetes using diet and exercise or taking stable oral glucose-lowering medication randomized patients 3:2 to either exenatide QWS-AI (2 mg) or exenatide BID (10 μg) for 28 weeks. The primary outcome was the 28-week change in glycated haemoglobin (HbA1c). A subset of patients completed a standardized meal test for postprandial and pharmacokinetic assessments.

RESULTS: A total of 375 patients (mean HbA1c, 8.5% [69 mmol/mol]; body mass index, 33.2 kg/m; diabetes duration, 8.5 years) received either exenatide QWS-AI (n = 229) or exenatide BID (n = 146); HbA1c was reduced by -1.4% and -1.0%, respectively (least-squares mean difference, -0.37%; P = .0072). More patients achieved HbA1c <7.0% with exenatide QWS-AI (49.3%) than with exenatide BID (43.2%; P = .225). Body weight was reduced in both groups (P = .37 for difference). Gastrointestinal adverse events (AEs) were reported in 22.7% (exenatide QWS-AI) and 35.6% (exenatide BID) of patients; fewer patients in the exenatide QWS-AI group withdrew because of AEs than in the exenatide BID group. Minor hypoglycaemia occurred most often with concomitant sulfonylurea use. 2

CONCLUSIONS: Exenatide QWS-AI was associated with a greater reduction in HbA1c, similar weight loss and a favorable gastrointestinal AE profile compared with exenatide BID.

Key numbers

-1.4%

HbA1c Reduction

Change in HbA1c after 28 weeks for exenatide QWS-AI

22.7%

Gastrointestinal Adverse Events

Proportion of patients with gastrointestinal AEs for exenatide QWS-AI

49.3%

HbA1c <7.0%

Proportion of patients achieving HbA1c <7.0% with exenatide QWS-AI

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Funding

Competing interests

C. H. W. has received research support and served as a consultant, advisor and speaker for AstraZeneca, Boehringer Ingelheim, Eli Lilly, Janssen, Novo Nordisk and Sanofi. J. R. has received research support from AstraZeneca, Boehringer Ingelheim, Bristol‐Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Hanmi, Intarcia, Janssen, Lexicon, Merck, Novo Nordisk, Pfizer and Sanofi, and has served on advisory boards of, or received consulting honoraria from, Boehringer Ingelheim, Daiichi Sankyo, Eli Lilly, Intarcia, Janssen, Merck, Novo Nordisk and Sanofi. M. L. V. was an employee of Bristol‐Myers Squibb during the conduct of the study. N. I. and P. Ö. are employees of AstraZeneca. F. D. was an employee of AstraZeneca during the development of this manuscript.

PubMed

How well and how safely a new once-weekly self-injected exenatide works compared to twice-daily exenatide in type 2 diabetes

Abstract

Key numbers

Full Text

Funding

Competing interests

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