endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
NCT Number: NCT03194945
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.
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Notify Me20 year–70 year
All sexes
Interventional
Phase 4
Guangzhou, Guangdong, 510080, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
short-term intensive CSII followed by Linagliptin 5mg qd and Metformin 0.5g bid for 48 weeks
Other names: CSII+Lina+Met
short-term intensive CSII followed by Linagliptin 5mg qd for 48 weeks
Other names: CSII+Lina
short-term intensive CSII followed by Metformin 0.5g bid for 48 weeks
Other names: CSII+Met
No OHA is given after short-term intensive CSII
Other names: CSII
Time frame: 48 weeks
proportion of patients achieving glycosylated hemoglobin A1C <7% at the end of sequential treatment in each treatment group.
Time frame: 48 weeks
proportion of patients achieving glycosylated hemoglobin A1C <6.5% at the end of sequential treatment in each treatment group.
Time frame: 48 weeks
Differences in β-cell indicators among treatment arms at the end of study.
Time frame: 48 weeks
Differences in insulin sensitivity indicators among treatment arms at the end of study.
Time frame: 48 weeks
Differences in incidence of adverse events among treatment arms at the end of study.
Sun Yat-sen University
Other
Effects of Linagliptin and Metformin Monotherapy or Combined Sequential Treatment After Early Short-term Intensive Insulin Treatment on Long-term Blood Glucose Control and Function of β Cells in Patients With Type 2 Diabetes
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