Type2 Diabetes
Conditions
Keywords
SGLT2 inhibitor, DPP4 inhibitor
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.
Interventions
DRUGSGLT2 inhibitor (Empagliflozin 25 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.
DRUGDPP4 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.
Sponsors
Mackay Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycated hemoglobin (HbA1c) | measurement at baseline, 12 week and 24 week | change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting blood glucose | measurement at baseline, 12 week and 24 week | change in fasting blood glucose in mg/dl from baseline to week 24 |
| Postprandial blood glucose | measurement at baseline, 12 week and 24 week | change in postprandial blood glucose in mg/dl from baseline to week 24 |
| Body weight | measurement at baseline, 12 week and 24 week | change in body weight in kilogram from baseline to week 24 |
| Hypoglycemia event | recorded at 12 week and 24 week | documented hypoglycemia (glucose monitor \<70mg/dl with hypoglycemia associated symptoms) from baseline to week 24 |
Countries
Taiwan
Contacts
Primary ContactYi-Hong Zeng, MD
Outcome results
None listed