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Diabetes Obes Metab. 2017 Jul 7. doi: 10.1111/dom.13056. [Epub ahead of print]

Efficacy and tolerability of the new autoinjected suspension of exenatide once weekly versus exenatide twice daily in patients with type 2 diabetes.

Author information

1
Rockwood Clinic, Spokane, Washington, USA.
2
Dallas Diabetes Research Center at Medical City, Dallas, Texas, USA.
3
Bristol-Myers Squibb, Princeton, New Jersey, USA.
4
AstraZeneca, Gaithersburg, Maryland, USA.

Abstract

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 on diet and exercise or 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 hemoglobin (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/m2 ; 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=0.0072). More patients achieved HbA1c <7.0% with exenatide QWS-AI (49.3%) than with exenatide BID (43.2%; p=0.225). Body weight was reduced in both groups (p=0.37 for difference). Gastrointestinal adverse events (AEs) were reported in 22.7% (exenatide QWS-AI) and 35.6% (exenatide BID) of patients; fewer patients withdrew because of AEs with exenatide QWS-AI than with exenatide BID. Minor hypoglycemia occurred most often with concomitant sulfonylurea use.

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.

KEYWORDS:

autoinjector; exenatide; glucagon-like peptide-1 receptor agonist; type 2 diabetes

PMID:
28685973
DOI:
10.1111/dom.13056
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