Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin in Newly Diagnosed Type 2 Diabetes
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
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, 448 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.
Phase:
Phase 4
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Guangdong General Hospital Guangdong Provincial Hospital of Traditional Chinese Medicine Guangdong Provincial People's Hospital Guangzhou First People's Hospital Nanfang Hospital of Southern Medical University Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University The Third Affiliated Hospital of Guangzhou Medical University The Third Affiliated Hospital of Southern Medical University Zhujiang Hospital