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NCT07606066ClinicalTrials.gov

A Study to Identify and Characterize Patients With Type 2 Diabetes Mellitus for Possible Participation in Ongoing or Future Type 2 Diabetes Mellitus Clinical Studies

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En resumen

The purpose of this study is to identify and characterize patients with known Type 2 Diabetes Mellitus (T2DM) for possible participation in ongoing or future T2DM clinical studies, and to characterize trends in key concomitant medication use in this patient…

Observacional2150 participantes buscados76 centros7 países

Categorías

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Not stated: Registered after enrolment began (about 20 days after the recorded start)First posted 2026-05-26; recorded start 2026-05-06
  • Present: Has a defined primary outcomeA primary outcome measure is listed in the record
  • Present: The primary outcome states a time frameThe primary outcome measure records a time frame
  • Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
  • Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
  • Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
  • Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Present: Sponsor has 1019 other studies in this databaseCounted from the lead sponsor named in the record (AstraZeneca)
  • Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation0/20

    Allocation not stated in the record

  • Blinding0/20

    Masking not stated in the record

  • Control arm0/15

    No comparator arm stated in the record

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 71 sites

  • Data monitoring committee0/7

    No data monitoring committee stated

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleLARGE

A large study, international in scope: 2,150 participants (target), run at 76 sites, across 7 countries.

How this score is built
  • Enrolment33/40

    2,150 participants (target)

  • Site count21/25

    71 sites

  • Country count12/15

    7 countries

  • Planned duration5/10

    Planned over about 11 months

  • Sponsor scale10/10

    AstraZeneca has led 991 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Resumen

The purpose of this study is to identify and characterize patients with known Type 2 Diabetes Mellitus (T2DM) for possible participation in ongoing or future T2DM clinical studies, and to characterize trends in key concomitant medication use in this patient population across different geographical regions.

Afecciones

  • Type 2 Diabetes

Elegibilidad

Elegibilidad
SexoTodos
Edades18 YearsSin máximo
Voluntarios sanosNo
Método de muestreoNON_PROBABILITY_SAMPLE

Población del estudio

Adults with Type 2 Diabetes

Elegibilidad tal como figura en el registro

Inclusion Criteria: * Participants must be ≥ 18 years of age at the time of signing the ICF. * Patients with a diagnosis of T2DM, test- or documentation-confirmed as per World Health Organization or local diagnostic standards, inadequately managed with: 1. Lifestyle management alone, AND/OR 2. A stable dose of background glucose-lowering medication(s) for T2DM (As specified in the Protocol) for at least 45 days prior to signing the ICF. * Expresses interest in participating in an ongoing or future T2DM clinical study, is motivated and willing to make themselves available for the duration of the study, and is able to follow study procedures as required. * Provision of signed and dated written informed consent (As specified in the Protocol) before any study-specific procedures, sampling, or analysis. Exclusion Criteria: * Current or planned use of GLP-1 RAs prohibited in ongoing or future T2DM studies evaluating the efficacy and safety of investigational GLP-1 RAs (As specified in the Protocol). * Diagnosed with Type 1 diabetes mellitus. * Known pregnancy at the time of visit or having the intention to become pregnant.

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudioObservacional
FaseNo indicado en el registro
AsignaciónNo indicado en el registro
Modelo de intervenciónNo indicado en el registro
Propósito principalNo indicado en el registro
EnmascaramientoNo indicado en el registro
Inscripción2150 participantes buscados

Patrocinador y colaboradores

  • AstraZeneca Patrocinador

Grupos e intervenciones

  • Participants with Type 2 Diabetes

    Participants with Type 2 Diabetes

Intervenciones

  • Otro Procedure: assessment

    The approximate volume of blood required is 2 mL

Variables de resultado

  1. Variable de resultado principal

    Patient demographics

    Summary statistics

    Plazo Visit 1 (Single day)

  2. Variable de resultado principal

    Medical and surgical history

    Summary statistics

    Plazo Visit 1 (Single day)

  3. Variable de resultado principal

    Concomitant medication

    Summary statistics

    Plazo Visit 1 (Single day)

  4. Variable de resultado principal

    HbA1c levels

    Summary statistics

    Plazo Visit 1 (Single day)

  5. Variable de resultado secundaria

    Referral to ongoing or future T2DM study.

    Number of participants with high likelihood of meeting eligibility criteria in ongoing or future T2DM studies, for referral to those studies.

    Plazo Visit 1 (Single day)

Fechas

Fechas
Fecha de inicio6 de mayo de 2026 (real)
Finalización principal31 de marzo de 2027 (estimada)
Finalización31 de marzo de 2027 (estimada)
Primera publicación26 de mayo de 2026 (real)
Última actualización25 de agosto de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezmarzo de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

19 centros están en reclutamiento

Brazil

Brazil
CentroCiudadEstado o regiónEstado
Research SiteBarretosAún no recluta
Research SiteBrasíliaAún no recluta
Research SiteCampinasSão PauloAún no recluta
Research SiteCuritibaParanáEn reclutamiento
Research SiteFortalezaCearáAún no recluta
Research SiteNatalRio Grande do NorteAún no recluta
Research SitePorto AlegreRio Grande do SulAún no recluta
Research SiteRio de JaneiroAún no recluta
Research SiteSão José dos CamposSão PauloAún no recluta
Research SiteSão PauloSão PauloAún no recluta
Research SiteSão PauloSão PauloAún no recluta

Hungary

Hungary
CentroCiudadEstado o regiónEstado
Research SiteBudapestEn reclutamiento
Research SiteBudapestAún no recluta
Research SiteBudapestEn reclutamiento
Research SiteBudapestHUEn reclutamiento
Research SiteBudapestHUEn reclutamiento
Research SiteDebrecenHUAún no recluta
Research SiteSalgótarjánAún no recluta
Research SiteSzegedHUAún no recluta
Research SiteSzolnokAún no recluta
Research SiteZalaegerszegEn reclutamiento

India

India
CentroCiudadEstado o regiónEstado
Research SiteBangaloreKarnatakaAún no recluta
Research SiteBelagaviKarnatakaAún no recluta
Research SiteBelagaviKarnatakaAún no recluta
Research SiteCalicutKeralaAún no recluta
Research SiteChennaiTamil NaduAún no recluta
Research SiteCoimbatoreTamil NaduAún no recluta
Research SiteDelhiNew DelhiAún no recluta
Research SiteGunturAndhra PradeshAún no recluta
Research SiteGuwahatiAssamAún no recluta
Research SiteIndoreMadhya PradeshAún no recluta
Research SiteJaipurRajasthanAún no recluta
Research SiteKochiKeralaAún no recluta
Research SiteKolkataWest BengalAún no recluta
Research SiteLucknowUttar PradeshAún no recluta
Research SiteMumbaiMaharashtraAún no recluta
Research SiteNagpurMaharashtraAún no recluta
Research SitePuneMaharashtraAún no recluta
Research SitePuneMaharashtraAún no recluta
Research SiteThiruvananthapuramKeralaAún no recluta

Malaysia

Malaysia
CentroCiudadEstado o regiónEstado
Research SiteBatu CavesSelangorRetirado
Research SiteKuala LumpurWilayah Persekutuan Kuala LumpAún no recluta
Research SitePutrajayaAún no recluta
Research SiteSerembanNegeri SembilanEn reclutamiento
Research SiteSeri ManjungPerakAún no recluta

Poland

Poland
CentroCiudadEstado o regiónEstado
Research SiteBialystokPodlaskie VoivodeshipEn reclutamiento
Research SiteCzęstochowaSilesian VoivodeshipAún no recluta
Research SiteKielceŚwiętokrzyskie VoivodeshipAún no recluta
Research SiteKrakowMalopolskaAún no recluta
Research SiteLodzŁódź VoivodeshipEn reclutamiento

En el registro figuran 26 centros más.

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

  1. 25 de agosto de 2026

    Centro añadido

    5 sites added (76 total)

    7176