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 value | |
| Randomization BG, mg/dl | 196±61 | 195±51 | 201±58 | 0.91 |
| Admission HbA1c, % | 8.9±2.2 | 8.3±2.0 | 8.5±1.7 | 0.22 |
| Length-of-stay, days, median Q1-Q3 | 4.0 (2.0-8.0) | 5.0 (3.0-7.0) | 4.0 (2.0-5.0) | 0.23 |
| Mean daily BG, days 2-10, mg/dl | 177±41 | 154±39 | 166±40 | 0.01 |
| BG at target 70-180 mg/dl, % | 61±39 | 78±31 | 63±31 | 0.02 |
| BG < 54 mg/dl, n (%) | 0 (0) | 1 (2.1) | 2 (4.1) | 0.77 |
| Nausea/vomiting, n (%) | 5 (10.6) | 5 (9.8) | 1 (1.9) | 0.17 |
| Withdrawal due to AE, n (%) | 3 (6.4) | 0 (0) | 0 (0) | 0.029 |
| Post-Discharge Data | ||||
| Exenatide (n= 48) | Basal Insulin (n= 55) | |||
| Mean daily BG, mg/dl | 156±63 | 141.±27 | 0.65 | |
| BG < 54 mg/dl, n (%)* | 4 (10) | 4 (11) | 1.0 | |
| Hospital re-admission, n (%) | 17% | 13% | 0.59 | |
| Nausea/vomiting, n (%) | 20 (53) | 1 (3) | <0.001 | |
| Withdrawal due to AE, n (%) | 5 (13) | 0 (0) | 0.05 | |
| HbA1c at 3 months, % | 8.2±1.9 | 7.3±1 | 0.07 | |
| Exenatide (n=47) | Exe+Basal (n=51) | Basal-Bolus (n=52) | P value | |
| Randomization BG, mg/dl | 196±61 | 195±51 | 201±58 | 0.91 |
| Admission HbA1c, % | 8.9±2.2 | 8.3±2.0 | 8.5±1.7 | 0.22 |
| Length-of-stay, days, median Q1-Q3 | 4.0 (2.0-8.0) | 5.0 (3.0-7.0) | 4.0 (2.0-5.0) | 0.23 |
| Mean daily BG, days 2-10, mg/dl | 177±41 | 154±39 | 166±40 | 0.01 |
| BG at target 70-180 mg/dl, % | 61±39 | 78±31 | 63±31 | 0.02 |
| BG < 54 mg/dl, n (%) | 0 (0) | 1 (2.1) | 2 (4.1) | 0.77 |
| Nausea/vomiting, n (%) | 5 (10.6) | 5 (9.8) | 1 (1.9) | 0.17 |
| Withdrawal due to AE, n (%) | 3 (6.4) | 0 (0) | 0 (0) | 0.029 |
| Post-Discharge Data | ||||
| Exenatide (n= 48) | Basal Insulin (n= 55) | |||
| Mean daily BG, mg/dl | 156±63 | 141.±27 | 0.65 | |
| BG < 54 mg/dl, n (%)* | 4 (10) | 4 (11) | 1.0 | |
| Hospital re-admission, n (%) | 17% | 13% | 0.59 | |
| Nausea/vomiting, n (%) | 20 (53) | 1 (3) | <0.001 | |
| Withdrawal due to AE, n (%) | 5 (13) | 0 (0) | 0.05 | |
| HbA1c at 3 months, % | 8.2±1.9 | 7.3±1 | 0.07 | |
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.
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..
