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J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5.

Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day.

Author information

1
Department of Clinical Sciences, Lund University, Lund, Sweden. Electronic address: bo.ahren@med.lu.se.
2
North-Western State Medical University named after I.I. Mechnikov, Endocrinology Department named after academician V.G. Baranov, St. Petersburg, Russian Federation.
3
Diabetes Division Clinical Development Department, Sanofi, Paris, France.
4
Diabetes Medical Operation Department, Sanofi, Chilly Mazarin, France.
5
Biostatistics and Programming, Sanofi NJ, USA.
6
LMC Diabetes & Endocrinology, Toronto, Canada.

Abstract

AIMS:

The aim of this study is to explore whether administration timing affects glycaemic control by lixisenatide once-daily in type 2 diabetes mellitus (T2DM).

METHODS:

A phase IIIb, open-label, 1:1 randomized, active-controlled, 24-week multicentre study of T2DM patients inadequately controlled on metformin was conducted. Patients were administered lixisenatide before breakfast or the main meal. The primary endpoint was change from baseline at week 24 in glycated haemoglobin (HbA1c). Other endpoints: changes in body weight, fasting plasma glucose (FPG), 7-point self-monitored plasma glucose (SMPG) and Diabetes Treatment Satisfaction Questionnaire status (DTSQs) score. Adverse events (AEs) were monitored.

RESULTS:

Mean change in HbA1c from baseline at week 24 was -0.65% (-7.1mmol/mol; main meal) and -0.74% (-8.1mmol/mol; breakfast). Mean changes in FPG, body weight and DTSQs score were comparable between groups. The mean change in body weight (kg) was -2.60 (main meal) and -2.80 (breakfast group). The 7-point SMPG profiles showed greatest reductions in postprandial glucose after the meal at which lixisenatide was administered, with a residual effect seen on the subsequent meal. AE rates were similar between groups, including gastrointestinal AEs.

CONCLUSIONS:

Lixisenatide before the main meal was noninferior to lixisenatide before breakfast in patients insufficiently controlled on metformin. Lixisenatide treatment allows flexibility in administration timing.

KEYWORDS:

Flexibility; Glycaemic control; Lixisenatide; Self-monitored plasma glucose; Type 2 diabetes mellitus

PMID:
25012990
DOI:
10.1016/j.jdiacomp.2014.05.012
[Indexed for MEDLINE]
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