A Phase 4 interventional study of SGLT2 inhibitor (Empagliflozin 25 MG) and DPP4 inhibitor (Linagliptin 5 MG) in Type2 Diabetes, sponsored by Mackay Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-03-08.
Sponsored by Mackay Memorial Hospital · Phase 4, Interventional, and Treatment
The population of type 2 diabetes increased enormously worldwide. As disease progression, uncontrolled type 2 diabetes patients need multiple daily insulin injections, but the risk of body weight gain and hypoglycemia will increase. In recent years, the newly oral anti-hypoglycemic agents developed, such as dipeptidyl peptidase-4 inhibitors (DPP4i) and sodium-glucose co-transporter 2 inhibitors (SGLT2i). The former indirectly stimulate insulin secretion and suppress glucagon through increase incretin. The later inhibit re-absorption of blood glucose in proximal renal tubule to improve hyperglycemia. According to the guideline published in 2017 by American diabetes Associations, if patients received premix insulin injections twice daily and their glycemic control can't meet the target, increase the frequency of injection such as basal bolus would be considered. However, it is difficult for some patients and it may cause more hypoglycemia and gain of body weight. Because previous report revealed dipeptidyl peptidase-4 inhibitors or sodium-glucose co-transporter 2 inhibitors added to insulin resulted in better glycemic control, but there was no direct comparison, so we design this study to observe the efficacy of these two drugs in uncontrolled diabetes patient received twice daily insulin injections.
Exclusion Criteria:
We add SGLT2 inhibitor (Empagliflozin 25 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy for 6 months.
Drug: SGLT2 inhibitor (Empagliflozin 25 MG)
We add DPP4 inhibitor (Linagliptin 5 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy.for 6 months.
Drug: DPP4 inhibitor (Linagliptin 5 MG)
We randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy.
Also known as: Jardiance
We randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy.
Also known as: Trajenta
Glycated hemoglobin (HbA1c)
change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24
Time frame: measurement at baseline, 12 week and 24 week
Fasting blood glucose
change in fasting blood glucose in mg/dl from baseline to week 24
Time frame: measurement at baseline, 12 week and 24 week
Postprandial blood glucose
change in postprandial blood glucose in mg/dl from baseline to week 24
Time frame: measurement at baseline, 12 week and 24 week
Body weight
change in body weight in kilogram from baseline to week 24
Time frame: measurement at baseline, 12 week and 24 week
Hypoglycemia event
documented hypoglycemia (glucose monitor \<70mg/dl with hypoglycemia associated symptoms) from baseline to week 24
Time frame: recorded at 12 week and 24 week
Plan to share: Yes
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Mackay Memorial Hospital