Safety and Efficacy of Exenatide Therapy for the Management of Hospitalized Patients with Type 2 Diabetes—Exenatide Hospital Trial

Abstract

This pilot multi-center, open-label, randomized trial determined the safety and efficacy of exenatide alone or in combination with basal insulin in medicine and surgery patients with type 2 diabetes (T2D). A total of 150 patients with blood glucose (BG) between 140-400 mg/dl on home therapy with oral agents or insulin ≤ 0.5 U/kg/day were treated with exenatide, exenatide+basal, or basal-bolus (BB) regimen. Exenatide was started at 5 mcg BID, basal insulin at 0.25 U/kg/d, and BB at 0.5 U/kg/d given half as glargine and half as lispro before meals. At discharge, pre-admission therapy was restarted and patients were randomized to exenatide (titrated to 10 mcg BID) or basal insulin, and followed for up to 3 months. The combination of exenatide and basal insulin resulted in lower hospital mean daily BG and higher proportion of target BG 70-180 mg/dl compared to exenatide or BB, p<0.01 (Table). There were no differences in hospital hypoglycemia, gastrointestinal (GI) adverse events or study withdrawal between groups. After discharge, there was no difference in BG control (p=0.65) but exenatide group had more GI adverse events (p<0.001) compared to basal group.Exenatide (n=47)Exe+Basal (n=51)Basal-Bolus (n=52)P valueRandomization BG, mg/dl196±61195±51201±580.91Admission HbA1c, %8.9±2.28.3±2.08.5±1.70.22Length-of-stay, days, median Q1-Q34.0 (2.0-8.0)5.0 (3.0-7.0)4.0 (2.0-5.0)0.23Mean daily BG, days 2-10, mg/dl177±41154±39166±400.01BG at target 70-180 mg/dl, %61±3978±3163±310.02BG < 54 mg/dl, n (%)0 (0)1 (2.1)2 (4.1)0.77Nausea/vomiting, n (%)5 (10.6)5 (9.8)1 (1.9)0.17Withdrawal due to AE, n (%)3 (6.4)0 (0)0 (0)0.029Post-Discharge DataExenatide (n= 48)Basal Insulin (n= 55)Mean daily BG, mg/dl156±63141.±270.65BG < 54 mg/dl, n (%)*4 (10)4 (11)1.0Hospital re-admission, n (%)17%13%0.59Nausea/vomiting, n (%)20 (53)1 (3)<0.001Withdrawal due to AE, n (%)5 (13)0 (0)0.05HbA1c at 3 months, %8.2±1.97.3±10.07 These preliminary results indicate that inpatient and post-discharge treatment with exenatide in combination with basal insulin is safe and effective for the management of general medicine and surgery patients with T2D. Disclosure M. Fayfman: None. D.L. Mize: None. D.J. Rubin: Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc.. I. Anzola: None. M.A. Urrutia: None. C. Ramos: None. F.J. Pasquel: Consultant; Self; Merck Sharp & Dohme Corp., Sanofi, Boehringer Ingelheim Pharmaceuticals, Inc.. J. Haw: None. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca. H. Wang: None. K.E. Joyce: None. A. Karunakaran: None. B.S. Albury: None. R. Weaver: None. L. Viswanathan: None. S. Jaggi: None. R.J. Galindo: None. G.E. Umpierrez: Research Support; Self; Sanofi US, Merck & Co., Inc., Novo Nordisk Inc., AstraZeneca. Advisory Panel; Self; Sanofi, Intarcia Therapeutics, Inc..