Biosimilar Insulin Significantly Lowers HbA1c in Mali, But Access Remains a Challenge

 © Santé Diabète

A glossary of the key scientific terms used in this press release is available at the end.

Bamako, Mali – March 12, 2025 – Our new study published in Diabetic Medicine has demonstrated significant improvements in glycaemic control among children and young adults living with Type 1 Diabetes (T1D) in Mali following the introduction of biosimilar glargine, a long-acting analogue insulin. This randomised controlled trial assessed the impact of usual care using long-acting and short-acting human insulin delivered using syringes versus switching the long-acting human insulin for biosimilar glargine administered via reusable pens.

The trial, which involved 260 participants under 25 years of age, found a marked reduction in HbA1c levels in the intervention group. Over 12 months, mean HbA1c levels in this group dropped from 103 mmol/mol (11.6%) to 65 mmol/mol (8.1%) (p < 0.001), whereas the control group, which continued on human insulin therapy, only saw a minor improvement from 101 mmol/mol (11.4%) to 93 mmol/mol (10.7%) (p < 0.01). Notably, the proportion of participants with high HbA1c (≥130 mmol/mol or 14%) fell to 0% in the intervention group, compared to a modest decline in the control group.

Key Strengths of the Study:

• Robust Study Design: The trial employed a rigorous randomised controlled approach, ensuring reliable comparisons between intervention and control groups.
• Large Sample Size: The inclusion of 260 participants strengthened the statistical power of the study and its applicability to similar settings.
• Comprehensive Diabetes Education: Both study groups received extensive diabetes self-management training, ensuring that any improvements were directly attributable to the change in insulin therapy rather than differences in patient education.
• High Adherence to Study Protocol: Apart from two premature deaths unrelated to the study protocol, all participants completed the trial, resulting in a comprehensive dataset.

Beyond the clinical results the study underscores the feasibility of transitioning to a basal-bolus insulin regimen with biosimilar insulin glargine in resource-limited settings.

For Stéphane Besançon, director of Santé Diabète and co-lead author of the study:
“The results of this study are highly compelling from a clinical point of view, but the issue of access to insulin, be it human or analogue remains unresolved in many low-and-middle-income countries like Mali. In these contexts, the issue of affordability for individuals and health systems remains a key barrier to ensuring proper outcomes for people with type 1 diabetes.”

The study underscores the feasibility of transitioning to a basal-bolus insulin regimen with biosimilar insulin glargine in resource-limited settings.

Work done by the ACCISS study ((Addressing the Challenge and Constraints of Insulin Sources and Supply), led by Health Action International and thethe University of Geneva, in partnership with Santé Diabète, has found that the median price individuals need to pay for analogue insulin in the public sector is 7 times higher than human insulin.

David Beran, Assistant Professor at thethe University of Geneva and also a co-author of the study, adds:
“This study is an excellent example of a collaboration and enabled new data to be generated as this is the first study of its kind in a context like Mali. However, in translating this science to policy and practice we cannot negate the wider health system factors that come with introducing a new medicine, especially one that is more expensive. Given these results we now need to work on guaranteeing access to insulin at affordable prices.”

The median price individuals need to pay for analogue insulin in the public sector is 7 times higher than human insulin.

Next Steps: Urgent Actions for Equitable Access to Insulin

Ensuring sustainable and affordable access to both human and analogue insulin is a critical next step in improving diabetes care worldwide. The World Health Organization's global targets coverage include that "100% of people with type 1 diabetes have access to affordable insulin and blood glucose self-monitoring". In order to achieve this, urgent action is required, including:

1. The World Health Organization (WHO):

1. • Promote the uptake of Prequalification of insulin
   • Develop practical guidance for countries to improve access to insulin and strengthen health systems for the management of type 1 diabetes.

2. The pharmaceutical industry:

1. • To implement their stated differential pricing commitments.
   • To work with partners to reduce their prices of analogue insulin significantly to guarantee equitable access for patients.

3. Governments:

1. • To integrate insulin and diabetes care into Universal Health Coverage (UHC) packages, ensuring that life-saving treatment is accessible to all who need it.

4. Civil society:

1. • To advocate and ensure the voices of people living with diabetes are heard
   • To document and disseminate evidence
   • To hold the private sector and governments to account

For more information, please contact:

Stéphane Besançon
Director of the NGO Santé Diabète
stephane.besancon@santediabete.org

About the study:

The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust and was conducted by the specialists in endocrinology in Mali with the NGO Santé Diabète, in collaboration with the Life for a Child program,the University of Geneva, the Geneva University Hospitals,the University of Luxembourg and theUniversity of Sidney.

Glossary of Key Scientific Terms:

• Type 1 diabetes (T1D) – A chronic autoimmune condition in which the pancreas does not produce insulin.
• Glycaemic Control – The management of blood sugar (glucose) levels within a target range to prevent complications.
• HbA1c (Glycated Hemoglobin) – A measure of average blood sugar levels over the past 2–3 months, expressed in mmol/mol (%) to assess long-term diabetes control.
• Biosimilar insulin – A biologic insulin product that is highly similar to an already approved reference insulin, with no clinically meaningful differences in efficacy or safety.
• Glargine (Insulin Glargine) – A long-acting analogue insulin used to maintain stable blood sugar levels throughout the day and night.
• Basal-Bolus Insulin Regimen – A diabetes treatment strategy combining long-acting (basal) insulin and short-acting (bolus) insulin to mimic natural insulin secretion.
• Randomised Controlled Trial (RCT) – A study design that randomly assigns participants to an intervention group or a control group to compare outcomes scientifically.
• Intervention Group – The group of participants in a clinical study receiving the experimental treatment (e.g., biosimilar insulin glargine in this trial).
• Control Group – The group of participants receiving standard care or placebo, used as a comparison for measuring the effects of the intervention.
• Statistical Significance (p-value)) – A measure indicating whether the results of a study are likely due to chance. A p-value) p-value of <0.05 suggests strong evidence against chance findings.
• Universal Health Coverage (UHC) – A healthcare system ensuring that all individuals receive the medical services they need without financial hardship.