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The META Trial

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PREVENTING AND DELAYING THE DEVELOPMENT OF DIABETES IN AFRICA A RANDOMISED PLAC...

PREVENTING AND DELAYING THE DEVELOPMENT OF DIABETES IN AFRICA A RANDOMISED PLACEBO CONTROLLED DOUBLE BLIND PHASE III TRIAL OF METFORMIN IN HIV INFECTED PERSONS WITH PRE DIABETES Diabetes is a common co-morbidity among people living with HIV. Since Oct 2021, we have been conducting a phase III randomised placebo-controlled trial of metformin among people living with HIV and pre-diabetes in Dar es Salaam, T... ver más

31/12/2026

FUNDACION PRIVADA...

2M€

Presupuesto del proyecto: 2M€

Líder del proyecto

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL B... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5 | 27M€

Fecha límite participación Sin fecha límite de participación.

Ver 7 Participantes

Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2024-03-05

HORIZON-JU-GH-EDCTP3-2023-01-02: Funding to successfully finalise ED... Expected Impact:Expected impacts of the calls under the 2023 work programme of the Global Health EDC...

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Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

7 Participantes

FUNDACION PRIVADA INSTITUTO...

319.85K€ | Lider

LIVERPOOL SCHOOL OF TROPICAL...

N.D. | Participante

THE REGISTERED TRUSTEES OF S...

NUID UCD

103.47K€ | Participante

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Duración del proyecto: 33 meses Fecha Inicio: 2024-03-05
Fecha Fin: 2026-12-31

Líder del proyecto

FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL B... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5 | 27M€

Presupuesto del proyecto 2M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto Diabetes is a common co-morbidity among people living with HIV. Since Oct 2021, we have been conducting a phase III randomised placebo-controlled trial of metformin among people living with HIV and pre-diabetes in Dar es Salaam, Tanzania (EDCTP RIA2018CO-2513). The aim is to test whether metformin can prevent progression to diabetes among people living with HIV. The primary endpoint is the time to diabetes. We had planned to enrol 2100 participants, follow-up for 3 years, and finish at the end of Dec 2024. COVID-19 resulted in severe delays to regulatory review. HIV care was decentralised away from health facilities to community posts to reduce COVID-19 risk, which led to much slower recruitment. We have now enrolled 1550 participants over the last 20 months. Less than 1% have been lost to follow-up. We will reach our target recruitment in Dec 2023 and will continue follow-up until Dec 2025. This will provide an average follow-up of 3 years per participant. Analyses of aggregated data to date show that glucose levels and weight have fallen over first 12 months among the trial cohort. Thus, we believe that trial will answer the research question by continuing follow-up until Dec 2025. In 2026, we will disseminate the findings to stakeholders and to the international bodies. We are collecting clinical, health economics, and qualitative data. The trial is being done as an equitable partnership between European and African researchers, and in partnership with Ministry of Health policy-makers and African patient representative bodies. We have good links with the African Centres for Disease Control, World Health Organisation (WHO-AFRO and Geneva offices), and Global Fund in order to inform policy considerations. Merck Pharma has provided medicinal products including the placebo.

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