Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
This is a multicenter, randomized, controlled, open-label, clinical superiority trial. The participants will be recruited from 10 centers in China. The enrolled participants will be randomly assigned into 3 groups, designated as Group A , B and C.
Group A (CSII with wearables):Continuous subcutaneous insulin infusion (CSII) will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended. The participants are wearing wearables.
Group B (CSII without wearbles): CSII will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended.
Group C (Basal insulin treatment): The participants will be applied the combination therapy of basal insulin, vildagliptin and metformin for the entire 12 weeks and then insulin will be suspended.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CSII with wearables | Experimental | Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. Wearable devices will be used. |
|
| CSII without wearbles | Experimental | Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. |
|
| Basal insulin group | Active Comparator | The combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks and thereafter the oral hypoglycemic therapies will be applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CSII and thereafter combination therapy, followed up with wearable devices | Drug | Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Wearable devices will be used to manage and follow-up the participants. |
| Measure | Description | Time Frame |
|---|---|---|
| the proportions of treatment de-escalation | the proportions of patients who can use only combination of two oral hypoglycemic agents | 24 weeks after the insulin treatment |
Not provided
Not provided
Inclusion Criteria:
Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1~15 years;
With two or more oral hypoglycemic drugs, or basal insulin and 1-2 oral hypglycemic agents, used for at least 3 months;
HbA1c of 7.5 to 13% and fasting C-peptide > 0.4 nmol/L;
Age of 18 to 70 years;
BMI of 20 to 35 kg/m²;
Capable of and willing to follow doctors' instructions to:
Self-monitor blood glucose according to the protocol;
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yanbing Li, Dr | FAH-SYSU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of endocrinology, FAH-SYSU | Guangzhou | Guangdong | 510080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CSII and thereafter combination therapy | Drug | Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin. |
|
| Basal insulin treatment without wearables | Drug | The participants will be applied the combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks. |
|
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
Not provided
Not provided