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Stage 2: Decreased levels of B12 and metabolic abnormalities such as high homocysteine or methylmalonic acid (MMA) levels

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Glimepiride (CAROLINA) study, the cardiovascular safety of linagliptin was compared with the sulfonylurea glimepiride on top of standard of care in 6,033 subjects with type 2 diabetes and increased cardiovascular risk or established cardiovascular disease over a median follow-up period of 6 years