Summary
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.
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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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/101145764 |
| Start date: | 01-01-2025 |
| End date: | 31-12-2026 |
| Total budget - Public funding: | 1 811 067,50 Euro - 1 811 067,00 Euro |
Cordis data
Original description
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.
Status
SIGNEDCall topic
HORIZON-JU-GH-EDCTP3-2023-01-02Update Date
15-11-2024
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Organisations
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| FUNDACION PRIVADA INSTITUTO DE SALUD GLOBAL BARCELONA (Coördinator)
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| LIVERPOOL SCHOOL OF TROPICAL MEDICINE
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| NATIONAL INSTITUTE FOR MEDICAL RESEARCH
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| THE REGISTERED TRUSTEES OF SHREE HINDU MANDAL DAR ES SALAAM
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| UMEA UNIVERSITET
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| UNIVERSITY COLLEGE LONDON
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| University College Dublin (UCD)