The addition of dapagliflozin alongside moderate calorie restricted diet leads to much higher rates of remission than the diet alone in patients with early type 2 diabetes, a study has concluded.
Use of the sodium glucose cotransporter-2 (SGLT-2) inhibitor drug in this group provides a ‘practical strategy’ to help patients reverse their diagnosis and avoid the need for other medicines, they concluded.
The approach was tested in a randomised controlled trial of 328 patients who’d had diabetes for less than six years.
Participants who were recruited at 16 centres across China were aged 20-70 years with a body mass index (BMI) greater than 25 and were not taking any anti-diabetic medication other than metformin.
They were also not taking weight loss drugs and patients with a history of gastric surgery were excluded.
In the year-long study, everyone had moderate calorie restriction of around 500-750 kcal/day with physical activity encouraged and half the group also taking dapagliflozin 10mg/day and half placebo.
At 12 months, 44% of participants in the dapagliflozin group were in remission – defined as maintaining normal blood sugar levels for at least two months after stopping anti-diabetic medication – compared with 28% in the placebo group, the researchers reported in the BMJ.
They also found a significantly greater reduction in body weight and insulin resistance in the dapagliflozin group as well as improvements in body fat mass, systolic blood pressure, and cholesterol levels.
The structured dietary programme was practicable and feasible in a clinical setting and participants had good adherence to the combination of SGLT-2 inhibitor and moderate calorie restriction, they concluded
In a linked editorial, UK researchers said the combined strategy was effective, but questions remain including whether glucose lowering drugs should be discontinued at the point of remission.
Also more research is needed on whether specific drug mechanisms be harnessed for a more individualised approach to remission of type 2 diabetes, they noted.
Dr Stephen Lawrence, a GP and associate clinical professor at the University of Warwick said study offered ‘an interesting and positive insight’ on the use of SGLT2 inhibitors for people with type 2 diabetes.
This was particularly true ‘given their elevated position in the NICE guideline as an add-on to metformin for people with diabetes presenting with a QRISK score of 10% (or more) or with pre-existing atherosclerotic cardiovascular disease’, he added.
‘The multicentre double blind randomised control design is particularly reassuring,’ he said. But he noted that diabetes remission is usually defined as three months which may have introduced a positive bias.
Last year a major study into the NHS ‘soups and shakes’ programme boosted hopes that type 2 diabetes remission can be achieved through at-scale intervention.
The real-world study in The Lancet Diabetes & Endocrinology, found that of those who completed the programme and were measured twice, one-in-three (32%) had put their type 2 diabetes into remission.
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