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

Phase 4

• Conditions: Type2 Diabetes
• Interventions: Drug: SGLT2 inhibitor (Empagliflozin 25 MG); Drug: DPP4 inhibitor (Linagliptin 5 MG)

• Registration Number: NCT03458715
• Lead Sponsor: Mackay Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-21
• Status Verified: 2017-10
• Study First Submitted: 2017-10-26
• Study First Submitted QC: 2018-03-07
• Last Update Submitted: 2018-03-07
• Study First Posted: 2018-03-08
• Last Update Posted: 2018-03-08
• Primary Completion: 2018-09-21
• Study Completion: 2018-11-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGLT2 inhibitor (Empagliflozin 25 MG)	SGLT2 inhibitor (Empagliflozin 25 MG)	We add SGLT2 inhibitor (Empagliflozin 25 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy for 6 months.
DPP4 inhibitor (Linagliptin 5 MG)	DPP4 inhibitor (Linagliptin 5 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.

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c)	measurement at baseline, 12 week and 24 week	change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24

Secondary Outcome Measures

Name	Time	Method
Body weight	measurement at baseline, 12 week and 24 week	change in body weight in kilogram from baseline to week 24
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
Hypoglycemia event	recorded at 12 week and 24 week	documented hypoglycemia (glucose monitor \<70mg/dl with hypoglycemia associated symptoms) from baseline to week 24

Trial Locations

Locations (1)

Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan