Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin in Newly Diagnosed Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT03194945|
Recruitment Status : Not yet recruiting
First Posted : June 21, 2017
Last Update Posted : June 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: CSII followed by Lina+MET Drug: CSII followed by Lina Drug: CSII followed by MET Drug: CSII alone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||448 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Active Comparator: Linagliptin plus metformin
CSII followed by Linagliptin 5 mg Qd + Metformin 0.5 g bid for 48 weeks
Drug: CSII followed by Lina+MET
short-term intensive CSII followed by Linagliptin 5mg qd and Metformin 0.5g bid for 48 weeks
Other Name: CSII+Lina+Met
Active Comparator: Linagliptin
CSII followed by Linagliptin 5mg Qd for 48 weeks
Drug: CSII followed by Lina
short-term intensive CSII followed by Linagliptin 5mg qd for 48 weeks
Other Name: CSII+Lina
Active Comparator: Metformin
CSII followed by Metformin 0.5 bid for 48 weeks
Drug: CSII followed by MET
short-term intensive CSII followed by Metformin 0.5g bid for 48 weeks
Other Name: CSII+Met
Active Comparator: Lifestyle alone
No OHA is given after CSII
Drug: CSII alone
No OHA is given after short-term intensive CSII
Other Name: CSII
- proportion of subjects with optimal glycemic control [ Time Frame: 48 weeks ]proportion of patients achieving glycosylated hemoglobin A1C <7% at the end of sequential treatment in each treatment group.
- proportion of subjects with excellent glycemic control [ Time Frame: 48 weeks ]proportion of patients achieving glycosylated hemoglobin A1C <6.5% at the end of sequential treatment in each treatment group.
- Change of β cell function [ Time Frame: 48 weeks ]Differences in β-cell indicators among treatment arms at the end of study.
- Change of insulin sensitivity [ Time Frame: 48 weeks ]Differences in insulin sensitivity indicators among treatment arms at the end of study.
- Incidence of adverse events [ Time Frame: 48 weeks ]Differences in incidence of adverse events among treatment arms at the end of study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194945
|Contact: Liehua Liu, PHDfirstname.lastname@example.org|
|endocrinology department of the first affiliated hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510080|