Remission of type 2 diabetes following a short-term intensive intervention with insulin glargine, sitagliptin and metformin: results of an open-label randomized parallel-design trial

Objective

The aim of the study was to evaluate remission of type 2 diabetes following a short-term intervention with insulin glargine, sitagliptin/metformin and lifestyle approaches.

Research Design and Methods

In this open multicenter trial, 102 patients with type 2 diabetes were randomized to (i) a 12-week intervention with sitagliptin/metformin, insulin glargine and lifestyle therapy or (ii) control group. Participants with HbA1C<7.3% [<56 mmol/mol] at 12 weeks were asked to stop diabetes medications and were followed for evidence of relapse over 52 weeks. Diabetes relapse criteria included HbA1C ≥6.5% [≥48 mmol/mol], ≥50% of capillary glucose readings >10 mmol/L over 1 week, re-initiation of diabetes medications ± abnormal fasting plasma glucose (FPG) or 2-hour plasma glucose on an oral glucose tolerance test (OGTT). Time-to-relapse analysis was conducted to compare the treatment groups with (primary analysis) and without (supplementary analysis) FPG/OGTT relapse criteria.

Results

With the FPG/OGTT relapse criteria included, the hazard ratio of relapse was 0.72 (95% CI 0.47-1.10) in the intervention group compared to the control group (primary analysis), and the number of participants remaining in remission was not significantly different between treatment groups at 24, 36, 48 and 64 weeks. In the supplementary analyses without these criteria, hazard ratio of relapse was 0.60 (95% CI 0.39-0.95), and the number of participants remaining in remission was significantly higher (26 vs 10%) in the intervention group at 36 weeks.

Conclusions

Although our primary outcome was not statistically significant, the tested approach deserves further study with further optimization of its components.