More than a third of patients with type 2 diabetes participating in the Diabetes Remission Clinical Trial (DiRECT) had remission of diabetes, according to 2-year data assessing the durability of the intervention, published in The Lancet Diabetes & Endocrinology.
DiRECT was a 2-year, open-label, cluster-randomized controlled trial aimed at assessing an integrated intervention led by primary care physicians for patients with type 2 diabetes. The intervention included rapid weight loss with a calorie-restricted formula-based diet, followed by gradual food introduction and a structured weight-loss maintenance program.
According to the results after 1-year intervention, published in 2017, 46% of the patients with type 2 diabetes attained remission. Now, the researchers report the clinical outcome at 2 years with the integrated weight-management program or best-practice care.
The study cohort included patients aged 20 to 65 years from primary care practices in Scotland and the Tyneside region of England. All patients had diabetes for ≤6 years and a body mass index of 27 to 45 kg/m2. The practices were randomly assigned (1:1) to provide either a structured weight-management program (intervention) or best-practice care (control). The coprimary outcomes were loss of ≥15 kg of body weight and remission of diabetes at 24 months, defined as glycated hemoglobin (HbA1c) <6.5% after withdrawal of all medications to treat diabetes at baseline.
According to study results after 24 months, weight loss of ≥15 kg was documented in 17 (11%) of 149 patients in the intervention group and 3 (2%) of 149 participants in the control group (adjusted odds ratio [aOR], 7.49; P =.0023). Remission of diabetes was attained in 53 patients (36%) in the intervention group compared with 5 patients (3%) in the control group (aOR, 25.82; P <.0001).
The mean weight loss after 24 months was 7.6 kg in the intervention group compared with 2.3 kg in the control group (P <.0001). In the intervention group, mean HbA1c decreased from 7.7% at baseline to 7.1% after 24 months, and although 74% of these patients required antidiabetes drugs at baseline, only 40% received treatment after 24 months. In the control group, mean HbA1c at baseline and after 24 months was stable, at 7.5%, and antidiabetes drugs were given to 77% of patients at baseline and 84% after 24 months.
Of 45 patients who maintained >10 kg of weight loss at 24 months (36 patients in the intervention group, 9 patients in the control group), 29 patients (64%) achieved remission of diabetes.
Serious adverse events after 24 months were reported in 11 patients (15 events) in the intervention group and in 19 patients (25 events) in the control group.
The researchers added that this real-life setting study had several inherent limitations, including the fact that participants and physicians were aware of the study group allocation. In addition, the extensive media coverage of the first-year results might have had an effect on the results.
In conclusion, a “structured primary care-based weight management [program] within 6 years of diagnosis can sustain remission to a [nondiabetic] state, off antidiabetes drugs, for more than a third of people with type 2 diabetes,” according to the researchers.
Lean MEJ, Leslie WS, Barnes AC, et al. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial [published online March 6, 2019]. Lancet Diabetes Endocrinol. doi:10.1016/S2213-8587(19)30068-3