NCT03958591

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

Effects of Short-Term Intensive De-escalation Therapy on Long-term Regimen Simplification in Patients With Poorly Controlled Type 2 Diabetes-- a Multicenter, Open-labeled, Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 274 (estimated)
• Sponsor: Yanbing Li · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Despite advances in diabetes management, many patients with type 2 diabetes in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags behind glycemic rise. The investigators design this study and presume that using vildagliptin and metformin in combination with basal insulin as sequential treatment after intensive insulin therapy, might better modulate the dual islet hormone dysfunction than traditionally stepwise upgrading therapy pattern in patients with poorly controlled T2DM, and thus lead to a glucose normalization, β-cell function improvement and therapy simplification.

Detailed description

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.

Conditions

• Diabetes type2

Interventions

Type	Name	Description
DRUG	CSII and thereafter combination therapy, followed up with wearable devices	Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Wearable devices and smart apps will be used to manage and follow-up the participants.
DRUG	CSII and thereafter combination therapy, followed up in traditional ways	Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Traditional ways such as telephone contact will be used for follow up.
DRUG	Traditionally upgrading therapy, followed up in traditional ways	The participants will be applied the combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks. Traditional ways will be used for follow up.

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-06-30
• Completion: 2022-12-31
• First posted: 2019-05-22
• Last updated: 2022-04-08

Locations

1 site across 1 country: China