Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Indication assessment · §3

Type 2 diabetes mellitus — trial records

Trial records in the Institute's register bearing on type 2 diabetes mellitus.

Document identifier
CEI-IN-02/3
Series
Indication assessment
Version
2.0
Published
28 Apr 2024
Last reviewed
28 Apr 2024
Next review
28 Apr 2026
Identifier
10.71829/cei.ind.2
Certainty
Not rated
Cycle
2024 Q2
ICD-11
5A11
Category
Metabolic

§3Trials in this indication

247 trial records in the Institute's register bear on this indication, of which 51 are published trials.

Table 2. Trial records bearing on type 2 diabetes mellitus.

RecordCompoundPhaseDesignRandomisedYear
STEP-2SemaglutidePhase 3Randomised, double-blind, placebo-controlled1,2102021
STEP-HFpEF-DMSemaglutidePhase 3Randomised, double-blind, placebo-controlled6162024
FLOWSemaglutidePhase 3Event-driven kidney outcome trial3,5332024
STRIDESemaglutidePhase 3Randomised, double-blind, placebo-controlled7922025
SUSTAIN-1SemaglutidePhase 3Randomised, double-blind, placebo-controlled3882017
SUSTAIN-6SemaglutidePhase 3Event-driven cardiovascular outcome trial3,2972016
SUSTAIN-7SemaglutidePhase 3Randomised, double-blind, active-controlled1,2012018
PIONEER-1Semaglutide, oralPhase 3Randomised, double-blind, placebo-controlled7032019
PIONEER-6Semaglutide, oralPhase 3Event-driven cardiovascular outcome trial3,1832019
SOULSemaglutide, oralPhase 3Event-driven cardiovascular outcome trial9,6502025
SURMOUNT-2TirzepatidePhase 3Randomised, double-blind, placebo-controlled9382023
SURPASS-1TirzepatidePhase 3Randomised, double-blind, placebo-controlled4782021
SURPASS-2TirzepatidePhase 3Randomised, double-blind, active-controlled1,8792021
SURPASS-3TirzepatidePhase 3Randomised, open-label, active-controlled1,4442021
SURPASS-4TirzepatidePhase 3Randomised, open-label, active-controlled2,0022021
SURPASS-5TirzepatidePhase 3Randomised, double-blind, placebo-controlled4752022
SURPASS-CVOTTirzepatidePhase 3Event-driven cardiovascular outcome trial13,2992025
RETA-PH2-T2DRetatrutidePhase 2Randomised, double-blind, placebo-controlled2812023
TRIUMPH-2RetatrutidePhase 3Randomised, double-blind, placebo-controlled
ORFO-PH2-T2DOrforglipronPhase 2Randomised, double-blind, placebo-controlled3832023
ATTAIN-2OrforglipronPhase 3Randomised, double-blind, placebo-controlled2025
ACHIEVE-1OrforglipronPhase 3Randomised, double-blind, placebo-controlled2025
ACHIEVE-2OrforglipronPhase 3Randomised, double-blind, active-controlled2025
REDEFINE-2CagriSema (cagrilintide with semaglutide)Phase 3Randomised, double-blind, placebo-controlled1,2062025
CAGRI-SEMA-PH2-T2DCagriSema (cagrilintide with semaglutide)Phase 2Randomised, double-blind, active-controlled922023
SYNCHRONIZE-2SurvodutidePhase 3Randomised, double-blind, placebo-controlled
ECNO-PH3-CN-T2DEcnoglutidePhase 3Randomised, double-blind, placebo-controlled2025
DANU-PH2B-T2DDanuglipronPhase 2bRandomised, double-blind, placebo-controlled4112023
LEADERLiraglutidePhase 3Event-driven cardiovascular outcome trial9,3402016
LEAD-6LiraglutidePhase 3Randomised, open-label, active-controlled4642009
AWARD-1DulaglutidePhase 3Randomised, double-blind, active-controlled9762014
AWARD-5DulaglutidePhase 3Randomised, double-blind, active-controlled1,0982014
AWARD-6DulaglutidePhase 3Randomised, open-label, active-controlled5992014
AWARD-7DulaglutidePhase 3Randomised, open-label, active-controlled5762018
AWARD-11DulaglutidePhase 3Randomised, double-blind, active-controlled1,8422020
REWINDDulaglutidePhase 3Event-driven cardiovascular outcome trial9,9012019
DURATION-1ExenatidePhase 3Randomised, open-label, active-controlled2952008
DURATION-6ExenatidePhase 3Randomised, open-label, active-controlled9112013
EXSCELExenatidePhase 3Event-driven cardiovascular outcome trial14,7522017
GETGOAL-MLixisenatidePhase 3Randomised, double-blind, placebo-controlled6802013
GETGOAL-LLixisenatidePhase 3Randomised, double-blind, placebo-controlled4952013
GETGOAL-DUO-1LixisenatidePhase 3Randomised, double-blind, placebo-controlled4462013
ELIXALixisenatidePhase 3Event-driven cardiovascular outcome trial6,0682015
AMIGO-1ExenatidePhase 3Randomised, double-blind, placebo-controlled3772005
AMPLITUDE-OExenatidePhase 3Event-driven cardiovascular outcome trial4,0762021
HARMONY-OUTCOMESDulaglutidePhase 3Event-driven cardiovascular outcome trial9,4632018
DREAMS-1MazdutidePhase 3Randomised, double-blind, placebo-controlled3192024
DREAMS-2MazdutidePhase 3Randomised, double-blind, placebo-controlled7312024
DREAMS-3MazdutidePhase 3Randomised, double-blind, active-controlled
MARITIDE-PH2-T2DMaridebart cafraglutidePhase 2Randomised, double-blind, placebo-controlled2024
PRAM-T2D-1YRPramlintidePhase 3Randomised, double-blind, placebo-controlled6562003
STEP-2-DDIprogramme recordSemaglutidePhase 1Randomised crossover2021
STEP-HFpEF-DM-BODY-COMPprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2024
SUSTAIN-1-QOLprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2017
SUSTAIN-6-BODY-COMPprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2016
SUSTAIN-7-BIOMARKERprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2018
PIONEER-1-REGIONAL-CNprogramme recordSemaglutide, oralPhase 3Randomised, double-blind, placebo-controlled2019
PIONEER-6-BIOMARKERprogramme recordSemaglutide, oralPhase 3Randomised, double-blind, placebo-controlled2019
SURMOUNT-2-PKprogramme recordTirzepatidePhase 1Phase 1 ascending dose2023
SURPASS-1-RENAL-IMPprogramme recordTirzepatidePhase 1Phase 1 ascending dose2021
SURPASS-2-ELDERLYprogramme recordTirzepatidePhase 3Randomised, double-blind, placebo-controlled2021
SURPASS-3-DDIprogramme recordTirzepatidePhase 1Randomised crossover2021
SURPASS-4-PKprogramme recordTirzepatidePhase 1Phase 1 ascending dose2021
SURPASS-5-RENAL-IMPprogramme recordTirzepatidePhase 1Phase 1 ascending dose2022
SURPASS-CVOT-PKprogramme recordTirzepatidePhase 1Phase 1 ascending dose2025
TRIUMPH-2-REGIONAL-CNprogramme recordRetatrutidePhase 3Randomised, double-blind, placebo-controlled
ATTAIN-2-ELDERLYprogramme recordOrforglipronPhase 3Randomised, double-blind, placebo-controlled2025
ACHIEVE-1-REGIONAL-JPprogramme recordOrforglipronPhase 3Randomised, double-blind, placebo-controlled2025
ACHIEVE-2-ELDERLYprogramme recordOrforglipronPhase 3Randomised, double-blind, placebo-controlled2025
REDEFINE-2-OLEprogramme recordCagriSema (cagrilintide with semaglutide)Phase 3Single-arm open-label2025
SYNCHRONIZE-2-REGIONAL-JPprogramme recordSurvodutidePhase 3Randomised, double-blind, placebo-controlled
FLOW-PKprogramme recordSemaglutidePhase 1Phase 1 ascending dose2024
SOUL-RENAL-IMPprogramme recordSemaglutide, oralPhase 1Phase 1 ascending dose2025
LEADER-OLEprogramme recordLiraglutidePhase 3Single-arm open-label2016
AWARD-1-DDIprogramme recordDulaglutidePhase 1Randomised crossover2014
AWARD-5-OLEprogramme recordDulaglutidePhase 3Single-arm open-label2014
AWARD-6-ADHERENCEprogramme recordDulaglutidePhase 3Observational2014
AWARD-7-REGIONAL-JPprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2018
AWARD-11-REGIONAL-CNprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2020
REWIND-REGIONAL-JPprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2019
DURATION-1-ELDERLYprogramme recordExenatidePhase 3Randomised, double-blind, placebo-controlled2008
DURATION-6-BIOMARKERprogramme recordExenatidePhase 3Randomised, double-blind, placebo-controlled2013
GETGOAL-M-BIOMARKERprogramme recordLixisenatidePhase 3Randomised, double-blind, placebo-controlled2013
GETGOAL-L-PKprogramme recordLixisenatidePhase 1Phase 1 ascending dose2013
GETGOAL-DUO-1-HEPATIC-IMPprogramme recordLixisenatidePhase 1Phase 1 ascending dose2013
ELIXA-DDIprogramme recordLixisenatidePhase 1Randomised crossover2015
EXSCEL-REGIONAL-CNprogramme recordExenatidePhase 3Randomised, double-blind, placebo-controlled2017
MARITIDE-PH2-T2D-REGIONAL-JPprogramme recordMaridebart cafraglutidePhase 3Randomised, double-blind, placebo-controlled2024
DREAMS-2-RENAL-IMPprogramme recordMazdutidePhase 1Phase 1 ascending dose2024
DREAMS-3-BODY-COMPprogramme recordMazdutidePhase 3Randomised, double-blind, placebo-controlled
STRIDE-QOLprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2025
AMPLITUDE-O-REGIONAL-JPprogramme recordExenatidePhase 3Randomised, double-blind, placebo-controlled2021
HARMONY-OUTCOMES-BODY-COMPprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2018
RETA-PH2-T2D-HEPATIC-IMPprogramme recordRetatrutidePhase 1Phase 1 ascending dose2023
ORFO-PH2-T2D-HEPATIC-IMPprogramme recordOrforglipronPhase 1Phase 1 ascending dose2023
CAGRI-SEMA-PH2-T2D-QOLprogramme recordCagriSema (cagrilintide with semaglutide)Phase 2Randomised, double-blind, placebo-controlled2023
ECNO-PH3-CN-T2D-ELDERLYprogramme recordEcnoglutidePhase 3Randomised, double-blind, placebo-controlled2025
DANU-PH2B-T2D-BODY-COMPprogramme recordDanuglipronPhase 2bRandomised, double-blind, placebo-controlled2023
LEAD-6-OLEprogramme recordLiraglutidePhase 3Single-arm open-label2009
AMIGO-1-RENAL-IMPprogramme recordExenatidePhase 1Phase 1 ascending dose2005
PRAM-T2D-1YR-HEPATIC-IMPprogramme recordPramlintidePhase 1Phase 1 ascending dose2003
STEP-2-HEPATIC-IMPprogramme recordSemaglutidePhase 1Phase 1 ascending dose2021
SUSTAIN-1-REGIONAL-CNprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2017
SUSTAIN-6-REGIONAL-JPprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2016
SUSTAIN-7-ADHERENCEprogramme recordSemaglutidePhase 3Observational2018
PIONEER-1-QOLprogramme recordSemaglutide, oralPhase 3Randomised, double-blind, placebo-controlled2019
PIONEER-6-ADHERENCEprogramme recordSemaglutide, oralPhase 3Observational2019
SURMOUNT-2-RENAL-IMPprogramme recordTirzepatidePhase 1Phase 1 ascending dose2023
SURPASS-1-PKprogramme recordTirzepatidePhase 1Phase 1 ascending dose2021
SURPASS-2-OLEprogramme recordTirzepatidePhase 3Single-arm open-label2021
SURPASS-3-HEPATIC-IMPprogramme recordTirzepatidePhase 1Phase 1 ascending dose2021
SURPASS-4-RENAL-IMPprogramme recordTirzepatidePhase 1Phase 1 ascending dose2021
SURPASS-5-PKprogramme recordTirzepatidePhase 1Phase 1 ascending dose2022
SURPASS-CVOT-RENAL-IMPprogramme recordTirzepatidePhase 1Phase 1 ascending dose2025
TRIUMPH-2-QOLprogramme recordRetatrutidePhase 3Randomised, double-blind, placebo-controlled
ATTAIN-2-OLEprogramme recordOrforglipronPhase 3Single-arm open-label2025
ACHIEVE-1-BODY-COMPprogramme recordOrforglipronPhase 3Randomised, double-blind, placebo-controlled2025
ACHIEVE-2-OLEprogramme recordOrforglipronPhase 3Single-arm open-label2025
REDEFINE-2-ELDERLYprogramme recordCagriSema (cagrilintide with semaglutide)Phase 3Randomised, double-blind, placebo-controlled2025
FLOW-RENAL-IMPprogramme recordSemaglutidePhase 1Phase 1 ascending dose2024
SOUL-PKprogramme recordSemaglutide, oralPhase 1Phase 1 ascending dose2025
LEADER-ELDERLYprogramme recordLiraglutidePhase 3Randomised, double-blind, placebo-controlled2016
AWARD-1-HEPATIC-IMPprogramme recordDulaglutidePhase 1Phase 1 ascending dose2014
AWARD-5-ELDERLYprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2014
AWARD-6-BIOMARKERprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2014
AWARD-7-BODY-COMPprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2018
AWARD-11-QOLprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2020
DURATION-1-OLEprogramme recordExenatidePhase 3Single-arm open-label2008
DURATION-6-ADHERENCEprogramme recordExenatidePhase 3Observational2013
GETGOAL-M-ADHERENCEprogramme recordLixisenatidePhase 3Observational2013
GETGOAL-L-RENAL-IMPprogramme recordLixisenatidePhase 1Phase 1 ascending dose2013
GETGOAL-DUO-1-DDIprogramme recordLixisenatidePhase 1Randomised crossover2013
ELIXA-HEPATIC-IMPprogramme recordLixisenatidePhase 1Phase 1 ascending dose2015
EXSCEL-QOLprogramme recordExenatidePhase 3Randomised, double-blind, placebo-controlled2017
MARITIDE-PH2-T2D-BODY-COMPprogramme recordMaridebart cafraglutidePhase 2Randomised, double-blind, placebo-controlled2024
DREAMS-2-PKprogramme recordMazdutidePhase 1Phase 1 ascending dose2024
DREAMS-3-REGIONAL-JPprogramme recordMazdutidePhase 3Randomised, double-blind, placebo-controlled
STRIDE-REGIONAL-CNprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2025
AMPLITUDE-O-BODY-COMPprogramme recordExenatidePhase 3Randomised, double-blind, placebo-controlled2021
HARMONY-OUTCOMES-REGIONAL-JPprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2018
RETA-PH2-T2D-DDIprogramme recordRetatrutidePhase 1Randomised crossover2023
ORFO-PH2-T2D-DDIprogramme recordOrforglipronPhase 1Randomised crossover2023
CAGRI-SEMA-PH2-T2D-REGIONAL-CNprogramme recordCagriSema (cagrilintide with semaglutide)Phase 3Randomised, double-blind, placebo-controlled2023
ECNO-PH3-CN-T2D-OLEprogramme recordEcnoglutidePhase 3Single-arm open-label2025
DANU-PH2B-T2D-REGIONAL-JPprogramme recordDanuglipronPhase 3Randomised, double-blind, placebo-controlled2023
LEAD-6-ELDERLYprogramme recordLiraglutidePhase 3Randomised, double-blind, placebo-controlled2009
AMIGO-1-PKprogramme recordExenatidePhase 1Phase 1 ascending dose2005
PRAM-T2D-1YR-DDIprogramme recordPramlintidePhase 1Randomised crossover2003
STEP-2-RENAL-IMPprogramme recordSemaglutidePhase 1Phase 1 ascending dose2021
SUSTAIN-1-REGIONAL-JPprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2017
SUSTAIN-6-REGIONAL-CNprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2016
SUSTAIN-7-OLEprogramme recordSemaglutidePhase 3Single-arm open-label2018
PIONEER-1-BODY-COMPprogramme recordSemaglutide, oralPhase 3Randomised, double-blind, placebo-controlled2019
PIONEER-6-OLEprogramme recordSemaglutide, oralPhase 3Single-arm open-label2019
SURMOUNT-2-HEPATIC-IMPprogramme recordTirzepatidePhase 1Phase 1 ascending dose2023
SURPASS-2-ADHERENCEprogramme recordTirzepatidePhase 3Observational2021
SURPASS-3-RENAL-IMPprogramme recordTirzepatidePhase 1Phase 1 ascending dose2021
SURPASS-4-HEPATIC-IMPprogramme recordTirzepatidePhase 1Phase 1 ascending dose2021
SURPASS-5-DDIprogramme recordTirzepatidePhase 1Randomised crossover2022
TRIUMPH-2-BODY-COMPprogramme recordRetatrutidePhase 3Randomised, double-blind, placebo-controlled
ACHIEVE-1-QOLprogramme recordOrforglipronPhase 3Randomised, double-blind, placebo-controlled2025
ACHIEVE-2-ADHERENCEprogramme recordOrforglipronPhase 3Observational2025
REDEFINE-2-BIOMARKERprogramme recordCagriSema (cagrilintide with semaglutide)Phase 3Randomised, double-blind, placebo-controlled2025
FLOW-HEPATIC-IMPprogramme recordSemaglutidePhase 1Phase 1 ascending dose2024
SOUL-DDIprogramme recordSemaglutide, oralPhase 1Randomised crossover2025
LEADER-BIOMARKERprogramme recordLiraglutidePhase 3Randomised, double-blind, placebo-controlled2016
AWARD-1-RENAL-IMPprogramme recordDulaglutidePhase 1Phase 1 ascending dose2014
AWARD-5-BIOMARKERprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2014
AWARD-6-ELDERLYprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2014
AWARD-7-QOLprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2018
AWARD-11-BODY-COMPprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2020
REWIND-QOLprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2019
DURATION-1-ADHERENCEprogramme recordExenatidePhase 3Observational2008
DURATION-6-OLEprogramme recordExenatidePhase 3Single-arm open-label2013
GETGOAL-M-OLEprogramme recordLixisenatidePhase 3Single-arm open-label2013
GETGOAL-L-HEPATIC-IMPprogramme recordLixisenatidePhase 1Phase 1 ascending dose2013
GETGOAL-DUO-1-PKprogramme recordLixisenatidePhase 1Phase 1 ascending dose2013
ELIXA-RENAL-IMPprogramme recordLixisenatidePhase 1Phase 1 ascending dose2015
EXSCEL-BODY-COMPprogramme recordExenatidePhase 3Randomised, double-blind, placebo-controlled2017
DREAMS-3-REGIONAL-CNprogramme recordMazdutidePhase 3Randomised, double-blind, placebo-controlled
STRIDE-REGIONAL-JPprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2025
AMPLITUDE-O-QOLprogramme recordExenatidePhase 3Randomised, double-blind, placebo-controlled2021
HARMONY-OUTCOMES-REGIONAL-CNprogramme recordDulaglutidePhase 3Randomised, double-blind, placebo-controlled2018
RETA-PH2-T2D-PKprogramme recordRetatrutidePhase 1Phase 1 ascending dose2023
ORFO-PH2-T2D-PKprogramme recordOrforglipronPhase 1Phase 1 ascending dose2023
CAGRI-SEMA-PH2-T2D-REGIONAL-JPprogramme recordCagriSema (cagrilintide with semaglutide)Phase 3Randomised, double-blind, placebo-controlled2023
DANU-PH2B-T2D-REGIONAL-CNprogramme recordDanuglipronPhase 3Randomised, double-blind, placebo-controlled2023
LEAD-6-BIOMARKERprogramme recordLiraglutidePhase 3Randomised, double-blind, placebo-controlled2009
AMIGO-1-DDIprogramme recordExenatidePhase 1Randomised crossover2005
PRAM-T2D-1YR-PKprogramme recordPramlintidePhase 1Phase 1 ascending dose2003
STEP-2-PKprogramme recordSemaglutidePhase 1Phase 1 ascending dose2021
SUSTAIN-1-BODY-COMPprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2017
SUSTAIN-6-QOLprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2016
SUSTAIN-7-ELDERLYprogramme recordSemaglutidePhase 3Randomised, double-blind, placebo-controlled2018
PIONEER-1-REGIONAL-JPprogramme recordSemaglutide, oralPhase 3Randomised, double-blind, placebo-controlled2019
PIONEER-6-ELDERLYprogramme recordSemaglutide, oralPhase 3Randomised, double-blind, placebo-controlled2019
SURMOUNT-2-DDIprogramme recordTirzepatidePhase 1Randomised crossover2023
SURPASS-2-BIOMARKERprogramme recordTirzepatidePhase 3Randomised, double-blind, placebo-controlled2021
SURPASS-3-PKprogramme recordTirzepatidePhase 1Phase 1 ascending dose2021
SURPASS-4-DDIprogramme recordTirzepatidePhase 1Randomised crossover2021
Showing the first 200 of 247. The full facet is at the trial register.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

  1. Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet 2019;394(10193):121–130. doi:10.1016/S0140-6736(19)31149-3 · PMID 31189511

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