India’s apex drug regulators have approved a clinical trial of a medicine that could expose diabetes patients to an increased risk of heart failure and possible death, medical experts have warned.

The Central Drugs Standard Control Organisation has approved a study in India that will be a part of an international clinical trial to examine the cardiovascular effects of treating diabetes patients with one of two drugs — rosiglitazone and pioglitazone.

Both drugs provide effective blood glucose control. But over the past three years, studies have indicated that rosiglitazone carries a higher risk of heart failure than pioglitazone. A joint statement last year from the American Diabetes Association and the European Diabetes Association had advised against the use of rosiglitazone in the control of diabetes.

But the clinical trial, supported by the pharmaceutical company GlaxoSmithKline and planned at dozens of sites in 15 countries, including 10 cities in India, will test rosiglitazone and pioglitazone in men and women above 50 who have diabetes.

Medical experts in India and North America have described the clinical trial as unethical, arguing that it ignores “accumulating evidence” and “a wealth of data” that suggests rosiglitazone carries greater risk than pioglitazone.

“It is most unethical and inhuman to administer a drug that is already known to be inferior to the molecule it is being compared with,” said Chandra Gulhati, editor of the Monthly Index of Medical Specialities, India, an independent journal of medicines.

One objective of the study is to determine how much more harm one drug causes than the other drug, said Ruth Macklin, a professor of epidemiology at the Albert Einstein College of Medicine, New York.

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