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None of these compounds has undergone a Phase 3 randomized controlled trial in humans that would support an FDA drug approval claim

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Table 10 Results of a 26-week Trial of Liraglutide Injection as Add-on to Metformin and Thiazolidinedione in Adult Patients with Type 2 Diabetes Mellitus a Liraglutide Injection Compared to Placebo Both With or Without metformin and/or Sulfonylurea and/or Pioglitazone and/or Basal or Premix insulin in Patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment In this 26-week, double-blind, randomized, placebo-controlled, parallel-group trial in adult patients with type 2 diabetes mellitus, 279 patients with moderate renal impairment, as per MDRD formula (eGFR 30-59 mL/min/1.73 m2), were randomized to liraglutide injection or placebo once daily

266 , C179C188 (1994)

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