A randomized 26-week study on glycemic control and hypoglycemia
Baptist Gallwitz, MD1, Michael Böhmer, MD2, Thomas Segiet, MD3, Andrea Mölle, MD4, Karsten Milek, MD5, Bernd Becker, MD6, Karin Helsberg, PHD7, Helmut Petto, PHD8, Natalie Peters, MSC7 and Oliver Bachmann, MD7
Corresponding author: Oliver Bachmann, firstname.lastname@example.org.
OBJECTIVE Hypoglycemia causes recurrent morbidity in patients with type 2 diabetes. This study evaluated if exenatide twice daily (BID) was noninferior to premixed insulin aspart 70/30 BID (PIA) for glycemic control and associated with less hypoglycemia.
RESEARCH DESIGN AND METHODS In this open-label study, metformin-treated adults with type 2 diabetes were randomized to 26-week treatment with exenatide BID (4 weeks 5 μg, then 10 μg) or PIA.
RESULTS Exenatide BID (n = 181) was noninferior to PIA (n = 173) for A1C control (least squares [LS] mean change −1.0 vs. −1.14%; difference [95% CI] 0.14 [−0.003 to 0.291]) and associated with a lower risk for hypoglycemia (8.0 vs. 20.5%, P < 0.05). LS mean weight decreased by 4.1 kg and increased by 1.0 kg with PIA (P < 0.001). A total of 39.2 vs. 20.8% of patients reached the composite end point of A1C <7.0%, no weight gain, and no hypoglycemia (P < 0.001; post hoc analysis).
CONCLUSIONS In metformin-treated patients, exenatide BID was noninferior to PIA for glycemic control but superior for hypoglycemia and weight control.
- Received October 5, 2010.
- Accepted December 1, 2010.
- © 2011 by the American Diabetes Association.
Read the full article here: http://care.diabetesjournals.org/content/34/3/604.full