The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin

Type2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03458715
• Other study ID #: 17MMHIS083
• Status: Recruiting
• Phase: Phase 4
• First received: October 26, 2017
• Last updated: March 7, 2018
• Start date: September 21, 2017
• Est. completion date: November 21, 2018

Study information

• Verified date: October 2017
• Source: Mackay Memorial Hospital
• Contact: Yi-Hong Zeng, MD
• Phone: +886-975835827
• Email: starrydouchain[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 21, 2018
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Drug:
• SGLT2 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.
• 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.

Locations

Country	Name	City	State
Taiwan	Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (HbA1c)	change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24	measurement at baseline, 12 week and 24 week
Secondary	Fasting blood glucose	change in fasting blood glucose in mg/dl from baseline to week 24	measurement at baseline, 12 week and 24 week
Secondary	Postprandial blood glucose	change in postprandial blood glucose in mg/dl from baseline to week 24	measurement at baseline, 12 week and 24 week
Secondary	Body weight	change in body weight in kilogram from baseline to week 24	measurement at baseline, 12 week and 24 week
Secondary	Hypoglycemia event	documented hypoglycemia (glucose monitor <70mg/dl with hypoglycemia associated symptoms) from baseline to week 24	recorded at 12 week and 24 week