Femme et Homme
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Extrait
Short-term: To evaluate the efficacy of saxagliptin 2.5 mg in adult patients with type 2 diabetes and renal impairment (moderate, severe and end-stage) compared with placebo by assessment of the absolute change from baseline in HbA1c and fasting plasma glucose To evaluate the safety and tolerability of saxagliptin 2.5 mg compared with placebo by assessment of AEs, laboratory values, ECG, vital signs, body weight and physical examination To characterize the PK properties of saxagliptin Long-term: To evaluate the safety and tolerability of sagliptin 2.5 mg compared with placebo by assessment of AEs, laboratory values, ECG, vital signs, body weight and physical examiniation To evaluate the efficacy of oral treatment with saxagliptin 2.5 mg compared with placebo by assessment of the absolute change from baseline in HbA1c and fasting plasma glucose To assess the change from baseline in background anti-diabetic therapy
Critère d'inclusion
- Type 2 diabetes mellitus