Piloting a Remission Strategy in Type 2 Diabetes: Results of a Randomized Controlled Trial.

Context: Medical strategies targeting remission of type 2 diabetes have not been systematically studied.

Objective: This trial assessed the feasibility, safety, and potential to induce remission of a short-term intensive metabolic strategy.

Design: A randomized, parallel, open-label pilot trial with 83 participants followed for 52 weeks.

Setting: Ambulatory care.

Participants: Patients with type 2 diabetes of up to 3 years in duration.

Interventions: Participants were randomized to: (1) an 8-week intensive metabolic intervention, (2) a 16-week intensive metabolic intervention, or (3) standard diabetes care. During the intensive intervention period, weight loss and normoglycemia were targeted using lifestyle approaches and treatment with metformin, acarbose, and insulin glargine. Diabetes drugs were then discontinued in the intervention groups and participants were followed for hyperglycemic relapse.

Primary Outcome: On-treatment normoglycemia.

Results: At 8 weeks, 50.0% of the 8-week intervention group vs 3.6% of controls achieved normoglycemia on therapy [relative risk (RR), 14.0; 95% confidence interval (CI), 1.97 to 99.38), and at 16 weeks, these percentages were 70.4% in the 16-week group and 3.6% in controls (RR, 19.7; 95% CI, 2.83 to 137.13). Twelve weeks after completion of the intervention, 21.4% of the 8-week group compared with 10.7% of controls (RR, 2.00; 95% CI, 0.55 to 7.22) and 40.7% of the 16-week group compared with 14.3% of controls (RR, 2.85; 95% CI, 1.03 to 7.87) met hemoglobin A1C criteria for complete or partial diabetes remission.

Conclusions: A short course of intensive lifestyle and drug therapy achieves on-treatment normoglycemia and promotes sustained weight loss. It may also achieve prolonged, drug-free diabetes remission and strongly supports ongoing studies of novel medical regimens targeting remission.