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A total of 484 patients with a mean duration of diabetes of 8.1 years were randomised to receive lixisenatide 20 g OD ( n = 323) or placebo ( n = 161) with a two-step dose increase, in combination with pioglitazone, for the main double-blind treatment period of 24 weeks, followed by a variable double-blind extension of at least 52 weeks

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