Available IPD datapackage for study 'An Open-label, Randomized, Three-parallel-group Study on Pharmacodynamic Effects of 8-week QD Treatment With Lixisenatide Compared to Liraglutide in Patients With Type 2 Diabetes Not Adequately Controlled With Insulin Glargine With or Without Metformin'

Primary Objective:

- To investigate the effects of repeated subcutaneous doses of lixisenatide 20 μg once daily
(QD) as compared to liraglutide 1.2 mg QD or 1.8 mg QD in reducing post-prandial plasma
glucose (PPG) assessed as area under the plasma glucose-concentration-time curve (AUC) after
a standardized breakfast at the end of a 8-week treatment period in participants with type 2
diabetes mellitus (T2DM) not adequately controlled with insulin glargine (± metformin).

Secondary Objectives:

- To assess the effects of lixisenatide 20 μg QD as compared to liraglutide 1.2 QD or 1.8
mg QD after an 8-week treatment period in participants with T2DM not adequately
controlled with insulin glargine (± metformin) on:

- Post-prandial C-peptide, glucagon and appetite perceptions after a standardized
breakfast,

- Appetite perceptions after standardized dinner,

- Gastric emptying after a standardized labelled test meal,

- Fasting plasma glucose, 24-hour plasma glucose profile,

- Glycosylated hemoglobin (HbA1c),

- Insulin glargine dose,

- 7-point self monitored plasma glucose (SMPG),

- Body weight and waist circumference,

- 24-hour heart rate and blood pressure,

- To assess lixisenatide and liraglutide safety and tolerability as add on treatment to
insulin glargine (± metformin).