Short-term intensive insulin therapy(SIIT) is able to reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. However, proportion of patients with response gradually decreases over time. There is no consensus on which treatment should be given in order to maintain the benefit in glycemic control and β cell recovery. In this multi-center, randomized, controlled study, effects of various sequential treatments ( metformin, linagliptin and combined with both drugs) on long-term blood glucose control as well as preservation of β cell function after SIIT were investigated. In total, 412 patients with newly diagnosed type 2 diabetes who meet the inclusive criteria will be enrolled in eight centers in China. After baseline assessments, all patients will be treated with insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of intensive treatment, insulin pump will be stopped. Different treatments will be applied to patients for 48 weeks according to randomization: Group A: Linagliptin 5 mg Qd + Metformin 0.5 g bid; Group B: Linagliptin 5 mg Qd; Group C: Metformin 0.5 g bid; Group D: No oral drugs. Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C \<7% at the end of the study. Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C \<6.5% at the end of study; differences in β-cell function , insulin sensitivity, GLP-1 and glucagon secretion among treatment groups, and differences in adverse events among treatment groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
412
short-term intensive CSII followed by Linagliptin 5mg qd and Metformin 0.5g bid for 48 weeks
short-term intensive CSII followed by Linagliptin 5mg qd for 48 weeks
short-term intensive CSII followed by Metformin 0.5g bid for 48 weeks
No OHA is given after short-term intensive CSII
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
proportion of subjects with optimal glycemic control
proportion of patients achieving glycosylated hemoglobin A1C \<7% at the end of sequential treatment in each treatment group.
Time frame: 48 weeks
proportion of subjects with excellent glycemic control
proportion of patients achieving glycosylated hemoglobin A1C \<6.5% at the end of sequential treatment in each treatment group.
Time frame: 48 weeks
Change of β cell function
Differences in β-cell indicators among treatment arms at the end of study.
Time frame: 48 weeks
Change of insulin sensitivity
Differences in insulin sensitivity indicators among treatment arms at the end of study.
Time frame: 48 weeks
Incidence of adverse events
Differences in incidence of adverse events among treatment arms at the end of study.
Time frame: 48 weeks
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