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Study Design

Study Design. Scirica BM, Bhatt DL Braunwald et al, Sexagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-1326. Study Design.

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Study Design

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  1. Study Design Scirica BM, Bhatt DL Braunwald et al, Sexagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-1326

  2. Study Design White WB, Cannon CP, Heller SR et al, Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-1335

  3. Study Design

  4. Change in HbA1c

  5. Hypoglycemia A hypoglycaemic event can be either: • An episode with symptoms and confirmed low glucose (<3 mmol/L) • An episode with low glucose • An episode with symptoms when glucose was not measured Minor hypoglycaemic events are considered when there is an awareness of the event, the event is tolerated, and the patient recovers by her/himself. In addition, the events resolved within 30 minutes of ingestion of carbohydrates (if possible confirmed with a fingerstick value). A measurement of blood glucose <54 mg/dL (<3.0 mmol/L) without symptoms is also considered an adverse event. Major hypoglycaemic events are events requiring the assistance of another person to actively administer carbohydrates, glucagons, or other resuscitative actions.

  6. Primary end point 14 HR 1.00 [0.89-1.12] P<0.001 (non-inferiority) 12 10 2y KM Saxagliptin 7.3% Placebo 7.2% 8 CV death, MI or ischemic CVA (%) 6 4 2 6 12 18 24 Months Placebo 8212 7983 7761 7267 4855 Scirica BM, Bhatt DL Braunwald et al, Sexagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-1326 8280 Saxagliptin 8071 7836 7313 4920

  7. Significantly more patients in the saxagliptin group than placebo werehospitalized for heartfailure Individual end points 2-year KM rate (%) Scirica BM, Bhatt DL Braunwald et al, Sexagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. N Engl J Med. 2013 Oct 3;369(14):1317-1326

  8. Primary end point White WB, Cannon CP, Heller SR et al, Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med. 2013 Oct 3;369(14):1327-1335

  9. Hospitalization for heart failure: pooled analysis Sattar N, Results from SAVOR and EXAMINE. DPP-4 inhibitors and CVD, EASD 2013 Sep 26.

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