Table 1.
Overview of study characteristics and inclusion criteria of included trials
| Study name (primary reference) NCT number | Study design | Inclusion criteria | Duration of follow-up | Randomized treatment | No. of patients randomized | Completion date | |||
|---|---|---|---|---|---|---|---|---|---|
| HbA1c | BMI | T2D duration | Background medication | ||||||
| SUSTAIN FORTE(14) NCT03989232 |
Phase 3b, double-blind, RCT Multinational |
8.0%-10.0% | No restriction | At least 6 mo | Metformin ≥ 1500 mg/d (or a maximal tolerated dose) ≥ 90 d with or without sulphonylurea (≥ half the maximum approved dose according to local label or maximum tolerated or effective dose) | 40 wk | Semaglutide 2.0 mg |
480 | November 2020 |
| Semaglutide 1.0 mg |
481 | ||||||||
| SUSTAIN 7(4)a NCT02648204 |
Phase 3b, open-label, RCT Multinational |
7.0%-10.5% | No restriction | Not specified | Metformin ≥ 1500 mg/d (or a maximal tolerated dose) ≥ 90 d | 40 wk | Semaglutide 1.0 mg |
300 | May 2017 |
| Dulaglutide 1.5 mg |
299 | ||||||||
| AWARD-11(11) NCT03495102 |
Phase 3, double-blind, RCT Multinational |
7.5%-11.0% | ≥25 kg/m2 | At least 6 mo | Metformin ≥ 1500 mg/d for ≥ 3 months | 36 wk | Dulaglutide 3.0 mg |
616 | May 2019 |
| Dulaglutide 4.5 mg |
614 | ||||||||
| Dulaglutide 1.5 mg |
612 |
Abbreviations: AWARD, A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes; BMI, body mass index; HbA1c, glycated hemoglobin; RCT, randomised controlled trial; SUSTAIN, A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes; T2D, type 2 diabetes.
a SUSTAIN 7 also included semaglutide 0.5 mg and dulaglutide 0.75 mg; however, these were not treatments of interest for the current analysis.