Clinical trial NCT03458715: The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin
Official title: The Efficacy and Safety of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase 4 Inhibitor Added to Premix Insulin Injection Twice Daily in Uncontrolled Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type2 Diabetes
Keywords: SGLT2 inhibitor
DPP4 inhibitor
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes patient received premix insulin twice daily and HbA1c\>7%
* \>20 years old

Exclusion Criteria:

* Type 1 diabetes and gestational diabetes
* Diabetic ketoacidosis in previous 6 months
* Urinary tract infection in previous 6 months
* Pancreatitis in previous 6 months
* estimated GFR\<45 mL/min/1.73m2
* Patient whom already received DPP4 inhibitor or SGLT2 inhibitor

Primary outcomes:
measure: Glycated hemoglobin (HbA1c)
timeFrame: measurement at baseline, 12 week and 24 week
Secondary outcomes:
measure: Fasting blood glucose
timeFrame: measurement at baseline, 12 week and 24 week
measure: Postprandial blood glucose
timeFrame: measurement at baseline, 12 week and 24 week
measure: Body weight
timeFrame: measurement at baseline, 12 week and 24 week
measure: Hypoglycemia event
timeFrame: recorded at 12 week and 24 week
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
Study officials:
References:
citation: Zeng YH, Liu SC, Lee CC, Sun FJ, Liu JJ. Effect of empagliflozin versus linagliptin on body composition in Asian patients with type 2 diabetes treated with premixed insulin. Sci Rep. 2022 Oct 12;12(1):17065. doi: 10.1038/s41598-022-21486-9.
citation: Liu SC, Lee CC, Chuang SM, Sun FJ, Zeng YH. Comparison of efficacy and safety of empagliflozin vs linagliptin added to premixed insulin in patients with uncontrolled type 2 diabetes: A randomized, open-label study. Diabetes Metab. 2021 May;47(3):101184. doi: 10.1016/j.diabet.2020.08.001. Epub 2020 Aug 19.