Assessing Prevalence and Predictors of Metformin Monotherapy Failure and Evaluating the Outcomes of Alternative Treatment Strategies

Author(s)

Yamini S. Bhamare, PharmD, Chandan A, PharmD, J M Srushti, PharmD, Rashmi Raman, PharmD, Kshreeraja S. Satish, PharmD.
Department of Pharmacy Practice, Faculty of Pharmacy, M S Ramaiah University of Applied Sciences, Bangalore, India.
OBJECTIVES: Type 2 diabetes mellitus (T2DM) is usually treated with metformin as the first-line therapy. However, studies have shown high prevalence of metformin monotherapy failure (MMF), which is defined as failure to achieve HbA1c <7% within 18 months or needing additional glucose lowering agents. Identifying contributing factors can guide timely interventions, such as lifestyle changes, combination therapy, or alternative agents, to achieve glycemic control. This study aims to assess MMF prevalence and predictors and evaluate alternate treatments strategies and their effectiveness.
METHODS: This prospective study included 196 T2DM patients on metformin monotherapy, followed from baseline until MMF. Relevant clinical and treatment data were collected to identify contributing factors. Potential causes, including adverse reactions and drug interactions, were assessed and appropriate strategies were implemented in consultation with physicians. Post-MMF, alternative therapies were documented, and treatment outcomes over three months were categorized as improved, worsened, or unchanged based on HbA1c changes.
RESULTS: Among 196 T2DM patients on metformin, the prevalence of MMF was 38.8%. Significant factors associated with MMF were higher baseline HbA1c, diet, medication adherence, and renal disorders. Post-MMF, metformin with glimepiride was the most prescribed alternative. Insulin and triple therapy showed greater reductions in HbA1c reductions over six months, with mean reductions ranging from 0.66 to 1.5 mmol/mol for triple therapy and 1.57 mmol/mol for insulin.
CONCLUSIONS: This study highlights the need to evaluate baseline HbA1c and renal function prior to metformin monotherapy initiation, along with counselling on medication adherence and dietary management for achieving better glycemic control. Following initial monotherapy, combination therapies may provide effective alternatives for patients who are hesitant to initiate injectable therapies. As a single-center study with small sample size and HbA1c as the sole measure, future studies should explore factors influencing alternative agents, compare post-metformin therapies, and assess overall glycemic control and safety across therapies.

Conference/Value in Health Info

2025-11, ISPOR Europe 2025, Glasgow, Scotland

Value in Health, Volume 28, Issue S2

Code

CO14

Topic

Clinical Outcomes, Health Service Delivery & Process of Care, Patient-Centered Research

Topic Subcategory

Clinical Outcomes Assessment

Disease

Diabetes/Endocrine/Metabolic Disorders (including obesity)

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