Conditions: Diabetes Mellitus, Type 2
Keywords: hyperglycemia, GLP-1, metformin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 639
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the benefits and risks of lixisenatide (AVE0010) in comparison to exenatide (Byetta®), as an add-on treatment to metformin, over a period of 24 weeks of treatment, followed by an extension.

The primary objective is to assess the effects of lixisenatide in comparison to exenatide (Byetta®), as an add-on treatment to metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.

The secondary objectives are to assess the effects of lixisenatide on percentage of patients reaching HbA1c less than 7 percent (%) or HbA1c less than or equal to (\<=) 6.5%, fasting plasma glucose (FPG), body weight; to evaluate safety, tolerability and to assess the impact of gastrointestinal tolerance on quality of life (QoL) (patient assessment of upper gastrointestinal disorders - quality of life \[PAGI-QOL\]).

Detailed description:
Patients who complete the 24-week main open-label treatment would undergo a variable open-label extension treatment, which ends for all patients at approximately the scheduled date of Week 76 visit (Visit 24) for the last randomized patient.

Arms:
arm 1: 2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to the end of treatment. arm 2: 1-step initiation regimen of exenatide: 5 mcg twice daily (BID) for 4 weeks, followed by 10 mcg BID up to the end of treatment.

Interventions: intervention 1: Lixisenatide (AVE0010) intervention 2: Pen auto-injector intervention 3: Exenatide intervention 4: Prefilled pen injector intervention 5: Metformin
Intervention descriptions: intervention 1: Self administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: None intervention 3: Self administered by subcutaneous injections twice daily within the hour preceding breakfast and within the hour preceding dinner. intervention 4: None intervention 5: Metformin to be continued at stable dose (at least 1.5 gram per day) up to the end of treatment.

Protocol document: