Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin (GetGoal-M-Asia)

• Percentage of patients reaching HbA1c < 7% and ≤ 6.5% at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
• Change from baseline in fasting blood glucose (FPG) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
• Change from baseline in 2-hour postprandial plasma glucose (PPG) after standardized meal test [ Time Frame: week 24 ] [ Designated as safety issue: No ]
• Change from baseline in glucose excursion after standardized meal test [ Time Frame: week 24 ] [ Designated as safety issue: No ]
• Change from baseline in body weight [ Time Frame: week 24 ] [ Designated as safety issue: No ]
• Percentage of patients requiring rescue therapy [ Time Frame: during 24-week period ] [ Designated as safety issue: No ]
• Plasma concentrations of lixisenatide prior to injection and in the time range from 1 to 2 hours and 4 to 6 hours post-injection [ Time Frame: week 2, week 24 ] [ Designated as safety issue: No ]
• Anti-lixisenatide antibody assessment [ Time Frame: baseline, week 2, week 4, week 24 ] [ Designated as safety issue: No ]

• Percentage of patients reaching HbA1c < 7% and ≤ 6.5% [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
• Change in FPG (fasting blood glucose) [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
• Change in 2-hour postprandial plasma glucose (PPG) and glucose excursion after standardized meal test [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
• Change in body weight [ Time Frame: from baseline to week 24 ] [ Designated as safety issue: No ]
• Percentage of patients requiring rescue therapy [ Time Frame: during 24-week period ] [ Designated as safety issue: No ]
• Plasma concentrations of lixisenatide prior to injection and in the time range from 1 to 2 hours and 4 to 6 hours post-injection [ Time Frame: at week 2 ] [ Designated as safety issue: No ]
• Plasma concentrations of lixisenatide prior to injection and in the time range from 1 to 2 hours and 4 to 6 hours post-injection [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
• Anti-lixisenatide antibody assessment [ Time Frame: at baseline ] [ Designated as safety issue: No ]
• Anti-lixisenatide antibody assessment [ Time Frame: at week 2 ] [ Designated as safety issue: No ]
• Anti-lixisenatide antibody assessment [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Primary Objective:

• To assess the effects on glycemic control of lixisenatide (AVE0010) in comparison to placebo as an add-on treatment to metformin with or without sulfonylurea in terms of HbA1c reduction over a period of 24 weeks in patients with type 2 diabetes mellitus (T2DM).

Secondary Objectives:

• To assess the effects of lixisenatide over 24 weeks on:

  • Percentage of patients reaching HbA1c < 7% or HbA1c ≤ 6.5%
  • Fasting plasma glucose (FPG)
  • 2-hour postprandial plasma glucose (PPG) and glucose excursion during standardized meal test (in all patients from selected sites)
  • Body weight
• To assess lixisenatide (AVE0010) safety and tolerability, pharmacokinetic (PK), and anti lixisenatide antibody development.

The study duration for each patient is 27 weeks +/- 10 days (up to 2 weeks screening + 1 week run-in + 24 weeks double-blind treatment + 3 days follow-up).

• Drug: Lixisenatide (AVE0010)

  Pharmaceutical form: aqueous solution

  Route of administration: subcutaneous

• Drug: Placebo

  Pharmaceutical form: aqueous solution

  Route of administration: subcutaneous

• Drug: Metformin
  Continued at a stable dose throughout the study
• Drug: Sulfonylurea
  If used at screening

• Experimental: Lixisenatide

  Titration phase (2 weeks): 10 µg lixisenatide (0.10 mL)

  Maintenance phase (up to the end of the double-blind treatment period): 20 µg lixisenatide (0.20 mL)

  As an add-on treatment to metformin with or without sulfonylurea

  Interventions:

  • Drug: Lixisenatide (AVE0010)
  • Drug: Metformin
  • Drug: Sulfonylurea
• Placebo Comparator: Placebo

  Titration phase (2 weeks): 0.10 mL

  Maintenance phase (up to the end of the double-blind treatment period): 0.20 mL

  As an add-on treatment to metformin with or without sulfonylurea

  Interventions:

  • Drug: Placebo
  • Drug: Metformin
  • Drug: Sulfonylurea

Inclusion criteria:

• Patients with T2DM diagnosed for at least 1 year and insufficiently controlled with metformin alone or metformin with sulfonylurea at the time of the screening visit and documented history of T2DM as defined by WHO (ie, fasting plasma glucose ≥ 7 mmol/L (126 mg/dL) or 2 hours postprandial plasma glucose ≥ 11.1 mmol/L (200 mg/dL).

Exclusion criteria:

• Metformin treatment has not been at a stable dose of at least 1.0 g/day or more than 1.5 g/day for at least 3 months prior to screening visit
• In case of treatment with sulfonylurea, if the sulfonylurea dosage is less than the maximum effective dose (ie, half of the maximum recommended dose according to local labeling), or is not at a stable (unchanged) dose for at least 3 months prior to screening.
• HbA1c < 7% or > 10% at screening

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.