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A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin (Eluminate-3)

18. juni 2026 opdateret af: AstraZeneca

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus on Background Insulin (Eluminate-3)

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults with Type 2 Diabetes Mellitus (T2DM), treated with a background insulin and other background glucose-lowering medication(s)

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

600

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Australien
      • East Toowoomba, Australien, 4350
        • Research Site
      • Parkville, Australien, 3050
        • Research Site
      • St Leonards, Australien, 2065
        • Research Site
  • Bulgarien
      • Dupnitsa, Bulgarien, 2600
        • Research Site
      • Kozloduy, Bulgarien, 3320
        • Research Site
      • Plovdiv, Bulgarien, 4001
        • Research Site
      • Sofia, Bulgarien, 1618
        • Research Site
      • Stara Zagora, Bulgarien, 6000
        • Research Site
      • Veliko Tarnovo, Bulgarien, 5000
        • Research Site
      • Yambol, Bulgarien, 8600
        • Research Site
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 4G8
        • Research Site
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Research Site
    • Ontario
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Scarborough Village, Ontario, Canada, M1R 0B1
        • Research Site
      • Toronto, Ontario, Canada, M4G3E8
        • Research Site
    • Quebec
      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Research Site
  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Research Site
    • California
      • Lincoln, California, Forenede Stater, 95648
        • Research Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Research Site
    • Florida
      • Ocoee, Florida, Forenede Stater, 34761
        • Research Site
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30030
        • Research Site
    • Maryland
      • Potomac, Maryland, Forenede Stater, 20854
        • Research Site
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27518
        • Research Site
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Research Site
    • South Carolina
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Research Site
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Research Site
    • Texas
      • Houston, Texas, Forenede Stater, 77040
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78231
        • Research Site
    • Washington
      • Renton, Washington, Forenede Stater, 98057
        • Research Site
  • Indien
      • Bangalore, Indien, 560 092
        • Research Site
      • Belagavi, Indien, 590006
        • Research Site
      • Chennai, Indien, 600086
        • Research Site
      • Coimbatore, Indien, 641018
        • Research Site
      • Guntur, Indien, 522001
        • Research Site
      • Hyderabad, Indien, 500034
        • Research Site
      • Indore, Indien, 452008
        • Research Site
      • Kochi, Indien, 682041
        • Research Site
      • Madurai, Indien, 625020
        • Research Site
      • Mumbai, Indien, 400012
        • Research Site
      • New Delhi, Indien, 110029
        • Research Site
      • Pune, Indien, 411021
        • Research Site
  • Japan
      • Asahikawa-shi, Japan, 070-8530
        • Research Site
      • Kashiwa-shi, Japan, 277-0825
        • Research Site
      • Komoro, Japan, 384-8588
        • Research Site
      • Kyoto, Japan, 606-8507
        • Research Site
      • Miyazaki, Japan, 880-0034
        • Research Site
      • Naka, Japan, 311-0113
        • Research Site
      • Yokohama, Japan, 230-8765
        • Research Site
  • Kina
      • Changsha, Kina, 410013
        • Research Site
      • Changsha, Kina, 410015
        • Research Site
      • Hefei, Kina, 230601
        • Research Site
      • Hefei, Kina, 230000
        • Research Site
      • Huai'an, Kina, 223005
        • Research Site
      • Langfang, Kina, 065000
        • Research Site
      • Liangyugang, Kina, 222002
        • Research Site
      • Luoyang, Kina, 471009
        • Research Site
      • Nanjing, Kina, 2100008
        • Research Site
      • Nanyang, Kina, 473009
        • Research Site
      • Pinggu, Kina, 101200
        • Research Site
      • Pingxiang, Kina, 337055
        • Research Site
      • Shijiazhuang, Kina, 050000
        • Research Site
      • Tianjin, Kina, 300134
        • Research Site
      • Yueyang, Kina, 414000
        • Research Site
  • Malaysia
      • Batu Caves, Malaysia, 68100
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Research Site
      • Miri, Malaysia, 98000
        • Research Site
      • Putrajaya, Malaysia, 62250
        • Research Site
      • Seremban, Malaysia, 70300
        • Research Site
  • Polen
      • Bialystok, Polen, 15-897
        • Research Site
      • Częstochowa, Polen, 42-217
        • Research Site
      • Kielce, Polen, 25-355
        • Research Site
      • Krakow, Polen, 31-261
        • Research Site
      • Lodz, Polen, 90-338
        • Research Site
      • Poznan, Polen, 60-354
        • Research Site
      • Radom, Polen, 26-600
        • Research Site
      • Warsaw, Polen, 02-507
        • Research Site
      • Warsaw, Polen, 00-124
        • Research Site
  • Sydkorea
      • Bucheon-si, Sydkorea, 14647
        • Research Site
      • Gyeonggi-do, Sydkorea, 13620
        • Research Site
      • Jongno-gu, Sydkorea, 110-746
        • Research Site
      • Junggu, Sydkorea, 22332
        • Research Site
      • Seoul, Sydkorea, 03080
        • Research Site
      • Seoul, Sydkorea, 03722
        • Research Site
      • Seoul, Sydkorea, 06591
        • Research Site
      • Seoul, Sydkorea, 5505
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10400
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Hat Yai, Thailand, 90110
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
      • Mueang, Thailand, 20000
        • Research Site
  • Tjekkiet
      • Broumov, Tjekkiet, 55001
        • Research Site
      • Ostrava, Tjekkiet, 710 00
        • Research Site
      • Pilsen, Tjekkiet, 301 00
        • Research Site
      • Prague, Tjekkiet, 140 00
        • Research Site
      • Prague, Tjekkiet, 170 00
        • Research Site
      • Prague, Tjekkiet, 181 00
        • Research Site
      • České Budějovice, Tjekkiet, 370 01
        • Research Site
  • Tyskland
      • Amberg, Tyskland, 92224
        • Research Site
      • Bad Oeynhausen, Tyskland, 32545
        • Research Site
      • Berlin, Tyskland, 13597
        • Research Site
      • Bochum, Tyskland, 44869
        • Research Site
      • Brandenburg an der Havel, Tyskland, 14776
        • Research Site
      • Daaden, Tyskland, 57567
        • Research Site
      • Duisburg, Tyskland, 47051
        • Research Site
      • Eisenach, Tyskland, 99817
        • Research Site
      • Elsterwerda, Tyskland, 04910
        • Research Site
      • Falkensee, Tyskland, 14612
        • Research Site
      • Frankfurt, Tyskland, 60596
        • Research Site
      • Fulda, Tyskland, 36037
        • Research Site
      • Gladbeck, Tyskland, 45968
        • Research Site
      • Hamburg, Tyskland, 22607
        • Research Site
      • Hannoversch Münden, Tyskland, 34346
        • Research Site
      • Magdeburg, Tyskland, 39120
        • Research Site
      • Mannheim, Tyskland, 68167
        • Research Site
      • Münster, Tyskland, 48153
        • Research Site
      • Nittendorf, Tyskland, 93152
        • Research Site
      • Obertshausen, Tyskland, 63179
        • Research Site
      • Oldenburg, Tyskland, 23758
        • Research Site
      • Pirna, Tyskland, 01796
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Diagnosed with T2DM for at least 90 days prior to screening
  • Stable treatment with background insulin and other background glucose-lowering medication(s)
  • HbA1c value of ≥ 7% to ≤ 10.5%
  • Body mass index (BMI) of ≥ 23 kg/m2 at screening
  • Stable body weight (self-reported or documented) for 90 days prior to screening

Exclusion Criteria:

  • T1DM, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma
  • Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema
  • Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
  • Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying
  • History of acute or chronic pancreatitis.
  • Severe congestive heart failure (NYHA IV)
  • History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Elecoglipron dose level 1
Participants will receive elecoglipron at dose level 1 administered orally once daily.
Medicin: Elecoglipron
Elecoglipron is administered orally once daily.
Eksperimentel: Elecoglipron dose level 2
Participants will receive elecoglipron at dose level 2 administered orally once daily.
Medicin: Elecoglipron
Elecoglipron is administered orally once daily.
Placebo komparator: Placebo
Participants will receive placebo administered orally once daily.
Medicin: Placebo
Placebo is administered orally once daily.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline in Hemoglobin A1c (HbA1c)
Tidsramme: Baseline to Week 40
Summary statistics
Baseline to Week 40

Sekundære resultatmål

Resultatmål
Tidsramme
Achieved HbA1c < 7% (53 mmol/mol) at Week 40
Tidsramme: Week 40
Week 40
Achieved HbA1c ≤ 6.5% (48 mmol/mol) at Week 40
Tidsramme: Week 40
Week 40
Percent change from baseline to Week 40 in body weight
Tidsramme: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in body weight (kg)
Tidsramme: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in Systolic blood pressure (SBP)
Tidsramme: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in fasting plasma glucose (FPG)
Tidsramme: Baseline to Week 40
Baseline to Week 40
Achieved HbA1c < 7% (53 mmol/mol) at Week 40 without hypoglycemia (glucose < 54 mg/dL [3.0 mmol/L] or severe hypoglycemia)
Tidsramme: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in daily mean 7-point self-monitoring blood glucose (SMBG)
Tidsramme: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in diastolic blood pressure (DBP)
Tidsramme: Baseline to Week 40
Baseline to Week 40
Change from baseline to Week 40 in total daily insulin dose (IU)
Tidsramme: Baseline to Week 40
Baseline to Week 40
Discontinued insulin by Week 40
Tidsramme: Baseline to Week 40
Baseline to Week 40

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

6. juli 2026

Primær færdiggørelse (Anslået)

23. maj 2028

Studieafslutning (Anslået)

23. maj 2028

Datoer for studieregistrering

Først indsendt

18. juni 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D7261C00006
  • 2025-523935-20-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD-delingstidsramme

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingsadgangskriterier

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Type 2 diabetes mellitus

Kliniske forsøg med Elecoglipron

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lithuania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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