Glucagon-Like Peptide 1 Receptor Agonist or Bolus Insulin With Optimized Basal Insulin in

Type 2 Diabetes

Featured Article:

Michaela Diamant, Michael A. Nauck, Rimma Shaginian, James K. Malone, Simon Cleall, Matthew Reaney, Danielle de Vries, Byron J.

Hoogwerf, Leigh MacConell, and Bruce H.R. Wolffenbuttel, for the 4BStudy Group

Diabetes Care Volume 37: 2763-2773

October, 2014

STUDY OBJECTIVE 

• To compare the efficacy and safety of exenatide twice daily or mealtime insulin lispro in patients inadequately controlled by insulin glargine and metformin despite up-titration

Diamant M. et al. Diabetes Care 2014;37:2763-2773

STUDY DESIGN AND METHODS

• Trial was a 30-week, open-label, multicenter, randomized, noninferiority trial with 12

• weeks prior insulin optimization

• 627 patients with insufficient postoptimization glycated HbA1c were randomized to exenatide (10–20 mg/day) or thrice-daily mealtime lispro titrated to a premeal glucose of 5.6–6.0 mmol/L

• Both were added to insulin glargine and metformin

Diamant M. et al. Diabetes Care 2014;37:2763-2773

RESULTS

• Randomization HbA1c and fasting glucose (FG) were 8.3% and 7.1 mmol/L for exenatide and 8.2% and 7.1 mmol/L for lispro, respectively

• At 30 weeks postrandomization, mean HbA1c changes were noninferior for exenatide compared with lispro

• Treatment differences were –0.04 in per-protocol and –0.03 in intent-to-treat populations

• FG was lower with exenatide than lispro

Diamant M. et al. Diabetes Care 2014;37:2763-2773

RESULTS

• Weight decreased with exenatide and increased with lispro

• More patients reported treatment satisfaction and better quality of life with exenatide than lispro

• A larger proportion of patients with exenatide experienced treatment-emergent adverse events

• Exenatide resulted in fewer nonnocturnal hypoglycemic episodes but more gastrointestinal adverse events than lispro

Diamant M. et al. Diabetes Care 2014;37:2763-2773

Diamant M. et al. Diabetes Care 2014;37:2763-2773

CONCLUSIONS

• Adding exenatide to titrated glargine with metformin resulted in similar glycemic control as adding lispro and was well tolerated

• Findings support exenatide as a noninsulin addition for patients failing basal insulin

Diamant M. et al. Diabetes Care 2014;37:2763-2773

Diamant M. et al. Diabetes Care 2014;37:2763-2773

Diamant M. et al. Diabetes Care 2014;37:2763-2773

Diamant M. et al. Diabetes Care 2014;37:2763-2773

Diamant M. et al. Diabetes Care 2014;37:2763-2773

Diamant M. et al. Diabetes Care 2014;37:2763-2773

Diamant M. et al. Diabetes Care 2014;37:2763-2773

Diamant M. et al. Diabetes Care 2014;37:2763-2773