Effects of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
This is a multicenter, randomized, controlled, open‐label, clinical superiority trial. The participants will be recruited from 19 centers in China. The enrolled participants will be randomly assigned into 3 groups, designated as Group A , B and C. Group A (Intensive therapy group following up with intelligent equipment):Continuous subcutaneous insulin infusion (CSII) will be applied to the participants for 2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks. The participants are followed up with intelligent equipment. Group B (Intensive therapy group following up in traditional ways): CSII will be applied to the participants for 2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks. The participants are followed up in traditional ways. Group C (Traditionally upgrading group): The participants will be applied the combination therapy of basal insulin, vildagliptin and metformin for the entire 12 weeks. Participants in both Group A, B and Group C will then receive combination therapy of metformin and vildagliptin, and be followed‐up at the 16th, 20th, 24th, 28th, 32nd and 36th weeks. The doses of metformin and vildagliptin are set as 1.0 2.0g/d and 100mg/d, respectively. If the participants cannot tolerate metformin, then acarbose (50‐100mg tid) or SGLT2 inhibitor can be instead used. If glucose is not well controlled, sulfonylureas or glinides can be added as a rescue treatment.
Epistemonikos ID: aef9a9fc202d970d0910a15a04850e6c8aad7df0
First added on: May 22, 2024