Table 3.
Summary of safety outcome findings.
| Outcome variables | Albiglutide arm | Control arm | Number of RCTs (participants) | Pooled effect size, RR (95% CI) |
I 2 (%) | P | Subgroup difference (albiglutide 30 vs 50 mg), P |
|---|---|---|---|---|---|---|---|
| Any AE | Albiglutide 30 mg | Placebo | 5 (929) | 1.09 (0.95–1.25) | 61 | .20 | .51 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 1.15 (1.06–1.26) | 26 | .001 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 1.03 (0.98–1.08) | 0 | .21 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 1.09 (0.97–1.23) | 0 | .14 | .43 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 1.02 (0.91–1.15) | 62 | .72 | ||
| Albiglutide 50 mg | Insulins | 3 (2124) | 1.07 (1.01–1.13) | 0 | .02 | NA | |
| Drug-related AE | Albiglutide 30 mg | Placebo | 3 (740) | 1.35 (1.01–1.81) | 14 | .04 | .11 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 1.84 (1.44–2.34) | 0 | <.00001 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 1.62 (1.37–1.91) | 0 | <.00001 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1311) | 2.25 (1.73–2.92) | 0 | <.00001 | NA | |
| Serious AE | Albiglutide 30 mg | Placebo | 5 (929) | 1.37 (0.47–4.03) | 66 | .56 | .67 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 1.07 (0.70–1.63) | 0 | .76 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 0.97 (0.68–1.38) | 42 | .86 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 7.63 (1.44–40.31) | 0 | .02 | .29 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 1.80 (0.22–14.80) | 59 | .58 | ||
| Albiglutide 50 mg | Insulins | 3 (2124) | 0.93 (0.68–1.27) | 0 | .66 | NA | |
| AE leading to withdrawal | Albiglutide 30 mg | Placebo | 3 (740) | 1.01 (0.51–2.02) | 0 | .98 | .40 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 1.57 (0.73–3.37) | 44 | .24 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 1.04 (0.64–1.69) | 51 | .87 | NA | |
| Albiglutide 50 mg | Insulins | 3 (2124) | 3.10 (1.40–6.86) | 33 | .005 | NA | |
| Hypoglycemia (any) | Albiglutide 30 mg | Placebo | 4 (822) | 1.61 (0.83–3.13) | 0 | .16 | .55 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 1.21 (0.62–2.35) | 61 | .57 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 0.83 (0.47–1.46) | 89 | .51 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 1.38 (0.41–4.60) | 0 | .60 | .41 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 0.82 (0.62–1.09) | 0 | .18 | ||
| Albiglutide 50 mg | Insulins | 3 (2124) | 0.74 (0.62–0.88) | 67 | .0009 | NA | |
| Documented symptomatic hypoglycemia | Albiglutide 30 mg | Placebo | 2 (503) | 1.43 (0.32–6.48) | 17 | .64 | .79 |
| Albiglutide 50 mg | Placebo | 3 (989) | 1.12 (0.43–2.95) | 43 | .82 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 0.68 (0.27–1.75) | 89 | .42 | NA | |
| Albiglutide 50 mg | Insulins | 3 (2124) | 0.65 (0.57–0.76) | 29 | <.00001 | NA | |
| Severe hypoglycemia | Albiglutide 30 mg | Placebo | 2 (503) | 5.03 (0.24–103.96) | NA | .30 | .54 |
| Albiglutide 50 mg | Placebo | 3 (989) | 1.28 (0.05–31.18) | NA | .88 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 0.29 (0.06–1.39) | 0 | .12 | NA | |
| Albiglutide 50 mg | Insulins | 3 (2124) | 0.44 (0.21–0.88) | 0 | .02 | NA | |
| Any GI AE | Albiglutide 50 mg | Placebo | 2 (586) | 1.48 (0.88–2.50) | 65 | .14 | NA |
| Albiglutide 50 mg | OADs | 2 (1043) | 1.28 (1.05–1.55) | 0 | .01 | NA | |
| Nausea | Albiglutide 30 mg | Placebo | 5 (929) | 1.09 (0.62–1.89) | 26 | .77 | .69 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 1.25 (0.81–1.94) | 1 | .32 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 1.73 (1.23–2.43) | 0 | .002 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 0.58 (0.30–1.12) | 0 | .11 | .83 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 0.69 (0.14–3.37) | 86 | .65 | ||
| Albiglutide 50 mg | Insulins | 3 (2124) | 4.26 (2.50–7.25) | 29 | <.00001 | NA | |
| Vomiting | Albiglutide 30 mg | Placebo | 4 (692) | 1.73 (0.75–3.97) | 0 | .20 | .53 |
| Albiglutide 50 mg | Placebo | 2 (586) | 3.01 (0.65–13.88) | 0 | .16 | ||
| Albiglutide 50 mg | OADs | 3 (1043) | 1.39 (0.56–3.42) | 0 | .48 | NA | |
| Albiglutide 50 mg | Insulins | 3 (2124) | 2.71 (0.83–8.82) | 80 | .10 | NA | |
| Decreased appetite | Albiglutide 30 mg | Placebo | 2 (383) | 1.11 (0.25–4.86) | 8 | .89 | NA |
| Dyspepsia | Albiglutide 30 mg | Placebo | 3 (585) | 1.03 (0.42–2.53) | 0 | .94 | .59 |
| Albiglutide 50 mg | Placebo | 3 (989) | 1.59 (0.44–5.73) | 28 | .48 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 1.60 (0.53–4.82) | 68 | .40 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1311) | 3.33 (0.44–25.29) | 72 | .24 | NA | |
| Abdominal pain | Albiglutide 30 mg | Placebo | 4 (692) | 0.47 (0.20–1.09) | 0 | .08 | .27 |
| Albiglutide 50 mg | Placebo | 3 (989) | 1.67 (0.20–13.78) | 75 | .63 | ||
| Albiglutide 50 mg | OADs | 3 (1459) | 1.66 (0.82–3.33) | 38 | .16 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1311) | 1.92 (0.25–14.49) | 70 | .53 | NA | |
| GERD | Albiglutide 30 mg | Placebo | 3 (585) | 2.67 (0.50–14.18) | 39 | .25 | .37 |
| Albiglutide 50 mg | Placebo | 3 (989) | 1.15 (0.53–2.49) | 1 | .73 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 0.84 (0.46–1.54) | 17 | .57 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1311) | 1.60 (0.77–3.29) | 0 | .21 | NA | |
| Diarrhea | Albiglutide 30 mg | Placebo | 5 (929) | 1.01 (0.53–1.93) | 41 | .98 | .54 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 1.28 (0.85–1.95) | 1 | .24 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 1.49 (1.12–2.00) | 0 | .007 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 0.52 (0.21–1.29) | 7 | .16 | .13 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 1.10 (0.80–1.52) | 0 | .56 | ||
| Albiglutide 50 mg | Insulins | 3 (2124) | 2.04 (1.45–2.88) | 0 | <.0001 | NA | |
| Constipation | Albiglutide 30 mg | Placebo | 5 (929) | 1.88 (0.86–4.10) | 0 | .11 | .21 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 0.93 (0.42–2.05) | 60 | .85 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 1.75 (1.15–2.68) | 0 | .009 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 1.17 (0.51–2.64) | 0 | .71 | .82 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 1.02 (0.43–2.41) | 65 | .97 | ||
| Albiglutide 50 mg | Insulins | 2 (1311) | 2.56 (1.27–5.20) | 0 | .009 | NA | |
| Injection-site reaction | Albiglutide 30 mg | Placebo | 5 (929) | 1.83 (1.03–3.23) | 0 | .04 | .03 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 4.87 (2.43–9.76) | 0 | <.00001 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 3.53 (2.33–5.36) | 6 | <.00001 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 5.03 (0.61–41.28) | 0 | .13 | .86 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 6.15 (2.52–15.02) | 0 | <.0001 | ||
| Albiglutide 50 mg | Insulins | 3 (2124) | 4.25 (2.13–8.47) | 0 | <.0001 | NA | |
| Diabetic retinopathy | Albiglutide 30 mg | Placebo | 2 (503) | 3.68 (1.04–13.03) | 0 | .04 | .25 |
| Albiglutide 50 mg | Placebo | 2 (586) | 1.34 (0.42–4.24) | 0 | .62 | ||
| Albiglutide 50 mg | OADs | 2 (1043) | 0.87 (0.40–1.87) | 45 | .72 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1379) | 0.47 (0.16–1.45) | 70 | .19 | NA | |
| Hypertension | Albiglutide 30 mg | Placebo | 4 (692) | 0.97 (0.57–1.66) | 0 | .91 | .83 |
| Albiglutide 50 mg | Placebo | 3 (989) | 1.05 (0.67–1.64) | 0 | .84 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 0.90 (0.65–1.23) | 0 | .49 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1311) | 0.90 (0.58–1.38) | 0 | .62 | NA | |
| Peripheral edema | Albiglutide 30 mg | Placebo | 3 (610) | 1.17 (0.53–2.60) | 0 | .70 | .37 |
| Albiglutide 50 mg | Placebo | 2 586) | 0.71 (0.33–1.49) | 3 | .36 | ||
| Albiglutide 50 mg | OADs | 3 (1043) | 0.70 (0.13–3.91) | 91 | .69 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1311) | 0.67 (0.32–1.40) | 61 | .29 | NA | |
| Headache | Albiglutide 30 mg | Placebo | 4 (692) | 1.05 (0.56–1.97) | 27 | .88 | .71 |
| Albiglutide 50 mg | Placebo | 2 (586) | 0.81 (0.24–2.69) | 72 | .73 | ||
| Albiglutide 50 mg | OADs | 3 (1043) | 0.82 (0.51–1.31) | 0 | .40 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1311) | 1.19 (0.61–2.32) | 55 | .61 | NA | |
| Cough | Albiglutide 30 mg | Placebo | 3 (585) | 0.92 (0.47–1.81) | 0 | .81 | .69 |
| Albiglutide 50 mg | Placebo | 3 (989) | 1.09 (0.68–1.76) | 0 | .73 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 1.18 (0.82–1.69) | 0 | .37 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1311) | 0.66 (0.41–1.06) | 0 | .09 | NA | |
| Sinusitis | Albiglutide 30 mg | Placebo | 3 (585) | 1.65 (0.82–3.32) | 0 | .16 | NA |
| Albiglutide 50 mg | Insulins | 2 (1311) | 1.04 (0.57–1.19) | 34 | .89 | NA | |
| Nasopharyngitis | Albiglutide 30 mg | Placebo | 5 (929) | 1.04 (0.74–1.47) | 0 | .81 | 1.00 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 1.04 (0.76–1.43) | 0 | .79 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 1.00 (0.60–1.65) | 65 | .99 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 1.18 (0.79–1.78) | 0 | .42 | .32 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 0.90 (0.64–1.27) | 0 | .57 | ||
| Albiglutide 50 mg | Insulins | 2 (1311) | 1.16 (0.78–1.73) | 0 | .45 | NA | |
| Upper RTI | Albiglutide 30 mg | Placebo | 4 (822) | 1.04 (0.65–1.69) | 0 | .86 | .71 |
| Albiglutide 50 mg | Placebo | 4 (1216) | 0.91 (0.53–1.56) | 47 | .73 | ||
| Albiglutide 50 mg | OADs | 3 (1954) | 0.94 (0.45–1.96) | 88 | .86 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 1.24 (0.48–3.24) | 0 | .66 | .77 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 1.07 (0.77–1.49) | 0 | .70 | ||
| Albiglutide 50 mg | Insulins | 3 (2124) | 0.95 (0.70–1.30) | 10 | .77 | NA | |
| UTI | Albiglutide 30 mg | Placebo | 3 (585) | 1.05 (0.47–2.35) | 0 | .91 | .69 |
| Albiglutide 50 mg | Placebo | 2 (586) | 1.29 (0.68–2.47) | 0 | .44 | ||
| Albiglutide 50 mg | OADs | 2 (1043) | 0.93 (0.63–1.35) | 0 | .70 | NA | |
| Albiglutide 50 mg | Insulins | 3 (2124) | 1.09 (0.78–1.51) | 0 | .62 | NA | |
| Arthralgia | Albiglutide 30 mg | Placebo | 3 (585) | 1.36 (0.53–3.51) | 21 | .53 | .71 |
| Albiglutide 50 mg | Placebo | 2 (586) | 1.10 (0.60–2.00) | 0 | .76 | ||
| Albiglutide 50 mg | OADs | 2 (1043) | 1.05 (0.66–1.65) | 0 | .85 | NA | |
| Albiglutide 50 mg | Insulins | 2 (1311) | 0.90 (0.33–2.49) | 71 | .84 | NA | |
| Back pain | Albiglutide 30 mg | Placebo | 5 (929) | 1.64 (0.88–3.05) | 0 | .12 | .36 |
| Albiglutide 50 mg | Placebo | 3 (813) | 1.10 (0.60–1.99) | 0 | .76 | ||
| Albiglutide 50 mg | OADs | 2 (1043) | 0.90 (0.56–1.45) | 0 | .67 | NA | |
| Albiglutide 30 mg | GLP-1 RAs | 2 (329) | 2.07 (0.63–6.85) | 0 | .23 | .17 | |
| Albiglutide 50 mg | GLP-1 RAs | 2 (1065) | 0.82 (0.45–1.49) | 0 | .51 | ||
| Albiglutide 50 mg | Insulins | 2 (1311) | 0.78 (0.52–1.19) | 0 | .25 | NA | |
| Thyroid cancer | Albiglutide 50 mg | Placebo | 2 (789) | 0.38 (0.04–3.62) | 0 | .40 | NA |
| Albiglutide 50 mg | OADs | 2 (1945) | 1.10 (0.09–11.08) | NA | .99 | NA |
AE = adverse events, CI = confidence interval, GERD = gastroesophageal reflux disease, GI = gastrointestinal, GLP-1 RA = glucagon-like peptide-1 receptor agonists, HbA1c = hemoglobin A1c, NA = not applicable, OAD = oral anti-hyperglycemic drug, RCTs = randomized controlled trials, RR = risk ratio, RTI = respiratory tract infection, UTI = urinary tract infection.