Background: We previously demonstrated that addition of exenatide (EXEN) plus pioglitazone (PIO) in poorly controlled T2DM patients on maximal dose of metformin plus sulfonylurea produced a greater A1c reduction at 1 year than basal-bolus insulin. Here we report the 3-year follow-up data.
Methods: 274 poorly controlled T2DM patients (age=56 y; BMI=31; Diabetes duration=11 y, HbA1c=10.1%) on maximal doses of metformin plus SU were randomized to receive: (1) Exenatide once weekly (2 mg) plus pioglitazone (n=142) or (2) basal (glargine)-bolus (aspart) insulin (n=132) to maintain HbA1c below 7%.
Results: In subjects receiving EXEN + PIO, A1c decreased to 6.5% at 6 months, and remained at 6.6% after 36 months. With Insulin Therapy, A1c declined to 7.5% at 6 months and remained 7.3 at 36 months (P<0.001) (Figure 1). More subjects receiving Insulin Therapy failed to achieve the A1c goal <7% (63% vs. 22%, p<0.0001). Despite lower A1c, subjects receiving EXEN + PIO had lower rate of hypoglycemia (P<0.001) compared to subjects receiving Insulin Therapy. Lastly, subjects receiving Insulin Therapy gained 4.1 kg vs. 1.7 kg (p=0.0002) vs. subjects treated with EXEN + PIO.
Conclusion: Addition of EXEN + PIO in poorly controlled T2DM patients on MET/SU produces greater and more durable HbA1c reduction with lower rate of hypoglycemia compared to Insulin Therapy.
M. Abdul-Ghani: None. O. Migahid: None. A. Megahed: None. M.F. Mohammad: None. R.A. DeFronzo: Speaker's Bureau; Self; AstraZeneca, Novo Nordisk Inc.. Advisory Panel; Self; AstraZeneca, Novo Nordisk Inc., Janssen Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Elcelyx Therapeutics, Inc., Intarcia Therapeutics, Inc.. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Takeda Pharmaceuticals U.S.A., Inc.. A. Jayyousi: None.