GlobalData analysed the number of clinical trials examining the drug metformin hydrochloride with start dates between 1 January 2009 and 17 September 2019.

Metformin hydrochloride is primarily used to treat and prevent type 2 diabetes.

Type 2 diabetes occurs when the pancreas is unable to produce insulin within the body, resulting in hyperglycemia. First approved in the 1960s, metformin works as an anti-diabetic agent that can be administered as either a film-coated tablet or a powdered oral solution. The drug works by decreasing hepatic glucose production and the amount of glucose absorbed in the intestines, resulting in overall decreased blood glucose levels. It can also improve insulin sensitivity by increasing peripheral glucose use. Additionally, Metformin can stimulate ovulation and help patients with polycystic ovarian syndrome.

Biomarkers can play a very important role in making sure trials investigating metformin come to completion. GlobalData analysed the five main leading biomarker roles for studies researching metformin (Figure 1). The main purpose of biomarkers in trials investigating metformin was found to be monitoring treatment response (82.0%). This was followed by having biomarkers in inclusion criteria and monitoring treatment response (10.7%), in inclusion criteria (4.0%), monitoring treatment safety (1.7%), and in exclusion criteria and monitoring treatment response (1.7%). The majority of analyzed trials were in Phase II (33.2%), followed by Phase IV (24.0%), Phase III (21.8%), and Phase I (20.9%)

Most of these trials were led by non-industry sponsors (58.9%). Among the top five countries to conduct metformin trials, the US had the highest percentage (67.7%).

Figure 1: Top 5 biomarker roles investigated in metformin trials

Figure 2: Metformin clinical trials initiated by phase