. 2011 Sep;13(9):873–881. doi: 10.1089/dia.2010.0250

Table 1.

Efficacy of Insulin in Combination with Glucagon-Like Peptide-1 Mimetics

		A1c (%)		Weight (kg)		Total insulin dose (U/day)
Study	Design	Baseline	Change	Baseline	Change	Baseline	End point
Arnolds et al.³² (2010)	Single-center, randomized, open-label, three-way active-comparator, 4-week study. GLAR dose was titrated to FBG ≤100 mg/dL. Grp 1, GLAR+MET+EXE; Grp 2, GLAR+MET+SITA; Grp 3, GLAR+MET. 48 subjects (16 per grp)	Grp 1, 8.4; Grp 2, 7.9; Grp 3, 7.9	Grp 1, −1.80; Grp 2, −1.49; Grp 3, −1.23	Grp 1, 94.2; Grp 2, 97.6; Grp 3, 96.3	Grp 1, −0.9; Grp 2, 0.1; Grp 3, 0.4	Grp 1, 40.3; Grp 2, 33.4; Grp 3, 32.3	Grp 1, 41.1; Grp 2, 35.0; Grp 3, 37.9
Buse et al.³³ (2011)	Multinational, multicenter, parallel, randomized, placebo-controlled, 30-week study in patients receiving >20 U/day GLAR with or without MET and/or pioglitazone for at least 3 months. Patients with A1c level ≤8% had baseline GLAR dose reduced by 20% for 5 weeks and then titrated to FBG <100 mg/dL. Grp 1, GLAR + EXE; Grp 2, GLAR + placebo	Grp 1, 8.3; Grp 2, 8.5	Grp 1, −1.74; Grp 2, −1.04	Grp 1, 95.4; Grp 2, 93.4	Grp 1, −1.78; Grp 2, 0.96	Grp 1, 49.5; Grp 2, 47.4	Change from baseline: Grp 1, 13; Grp 2, 20
Nayak et al.³⁴ (2010)	Single-center, single cohort/non-randomized, open-label, 6/12-mo study. Patients on large insulin doses were identified. Insulin dose and therapies were titrated to encourage weight loss while tolerating submaximal A1c at no worse than baseline or <10% change, whichever is lower, followed by addition of EXE. Up-titration of insulin was encouraged after 3–6 mo of EXE. Patients were followed up for 6 or 12 mo. 160 subjects (57 completed 12 mo of therapy)	6 mo, 8.8; 12 mo, 9.2	6 mo, −0.2; 12 mo, −0.1	6 mo, 121.8; 12 mo, 125.2	6 mo, −10.7; 12 mo, −12.8	6 mo, 144; 12 mo, 159. 96% using ≥2 inj/day; 4% using 1 inj/day	6 mo, 51; 12 mo, 55. At 6 mo, 37% using ≥2 inj/day; 24% not using insulin
Sheffield et al.³⁵ (2008)	Retrospective review of medical records of three private-practice endocrinologists. Patients (n = 124) treated with EXE in combination with insulin for at least 1 year	8.39	−0.87	111.1	−5.2	96% using basal insulin, 58% using prandial insulin. Dose: Basal, 48; Bolus, 26	96% using basal insulin, 32% using prandial insulin. Dose: Basal, 49; Bolus, 17
Viswanathan et al.³⁶ (2007)	Retrospective review of medical records from a single outpatient clinic. Patients (n = 52) with uncontrolled hyperglycemia and weight gain despite oral hypoglycemic agents plus insulin started EXE. Mean follow-up was 26 weeks. 38 patients continued EXE regularly, and 14 discontinued EXE therapy, with a maximum duration of treatment of ≤2 weeks (REF).	EXE, 7.7; REF, 8.4	EXE, −0.6; REF, 0.0	EXE, 116.4; REF, 118.0	EXE, −6.4; REF, +2.4	EXE: RAI, 50.4; Mix, 72.9; Basal, 58.4	EXE: RAI, 36.6; Mix, 28.3; Basal, 53.1
Yoon et al.³⁷ (2009)	Retrospective review of medical records from a single university hospital. Patients (n = 188) were treated with insulin in combination with EXE for up to 27 mo, with 157 followed up for 0–6 mo, 116 for 6–12 mo, 77 for 12–18 mo, and 35 for 18–27 mo.	8.05	0–6 mo, −0.66; 6–12 mo, −0.55; 12–18 mo, −0.54; 18–27 mo, −0.54	117.8	0–6 mo, −2.4; 6–12 mo, −4.3; 12–18 mo, −6.2; 18–27 mo, −5.4	Total, 99.9; Basal, 62.9; Bolus, 29.4	% change in basal/bolus: 0–6 mo, −3.9/−33.5; 6–12 mo, −6.3/−25.9; 12–18 mo, −2.3/−29.7; 18–27 mo, −7.2/−55.7

EXE, exenatide; FBG, fasting blood glucose; GLAR, insulin glargine; grp, group; inj, injections; MET, metformin; Mix, premixed insulin; mo, months; RAI, rapid-acting insulin; REF, reference group; SITA, sitagliptin.