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. 2019 Apr 24;16(4):303–309. doi: 10.1177/1479164119842339

Table 2.

Dose adjustments according to eGFR in the major clinical trials.

Trial Compound evaluated Renal exclusion criteria Dose adjustments
EXAMINE Alogliptin Requiring dialysis 14 days prior to screening 60 mL/min per 1.73 m2: 25 mg
30–60 mL/min per 1.73 m2: 12.5 mg
<30 mL/min per 1.73 m2: 6.25 mg
SAVOR-TIMI 53 Saxagliptin ESRF requiring dialysis, transplantation or serum creatinine > 6.0 mg per decilitre (530 μmol per litre) >50 mL/min per 1.73 m2: 5 mg
<50 mL/min per 1.73 m2: 2.5 mg
TECOS Sitagliptin eGFR < 30 mL/min per 1.73 m2 or requiring dialysis >50 mL/min per 1.73 m2: 100 mg
<50 mL/min per 1.73 m2: 50 mg
CARMELINA Linagliptin eGFR < 15 mL/min per 1.73 m2 or requiring dialysis None

EXAMINE3: Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care; SAVOR-TIMI 535: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus – Thrombolysis in Myocardial Infarction; TECOS4: Trial Evaluating Cardiovascular Outcomes with Sitagliptin; CARMELINA7,8: Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus; eGFR: estimated glomerular filtration rate; ESRF: end-stage renal failure.

Data were derived from the literature.3–5,7,8