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

Primary Purpose

Type2 Diabetes

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
SGLT2 inhibitor (Empagliflozin 25 MG)
DPP4 inhibitor (Linagliptin 5 MG)
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring SGLT2 inhibitor, DPP4 inhibitor

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SGLT2 inhibitor (Empagliflozin 25 MG)

DPP4 inhibitor (Linagliptin 5 MG)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glycated hemoglobin (HbA1c)
change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24

Secondary Outcome Measures

Fasting blood glucose
change in fasting blood glucose in mg/dl from baseline to week 24
Postprandial blood glucose
change in postprandial blood glucose in mg/dl from baseline to week 24
Body weight
change in body weight in kilogram from baseline to week 24
Hypoglycemia event
documented hypoglycemia (glucose monitor <70mg/dl with hypoglycemia associated symptoms) from baseline to week 24

Full Information

First Posted
October 26, 2017
Last Updated
March 7, 2018
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03458715
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
September 21, 2018 (Anticipated)
Study Completion Date
November 21, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
Keywords
SGLT2 inhibitor, DPP4 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SGLT2 inhibitor (Empagliflozin 25 MG)
Arm Type
Experimental
Arm Description
We add SGLT2 inhibitor (Empagliflozin 25 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy for 6 months.
Arm Title
DPP4 inhibitor (Linagliptin 5 MG)
Arm Type
Active Comparator
Arm Description
We add DPP4 inhibitor (Linagliptin 5 MG, oral, once daily) to type 2 diabetes patient poorly controlled with premix insulin therapy.for 6 months.
Intervention Type
Drug
Intervention Name(s)
SGLT2 inhibitor (Empagliflozin 25 MG)
Other Intervention Name(s)
Jardiance
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
DPP4 inhibitor (Linagliptin 5 MG)
Other Intervention Name(s)
Trajenta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glycated hemoglobin (HbA1c)
Description
change in glycated hemoglobin (HbA1c) in percentage from baseline to week 24
Time Frame
measurement at baseline, 12 week and 24 week
Secondary Outcome Measure Information:
Title
Fasting blood glucose
Description
change in fasting blood glucose in mg/dl from baseline to week 24
Time Frame
measurement at baseline, 12 week and 24 week
Title
Postprandial blood glucose
Description
change in postprandial blood glucose in mg/dl from baseline to week 24
Time Frame
measurement at baseline, 12 week and 24 week
Title
Body weight
Description
change in body weight in kilogram from baseline to week 24
Time Frame
measurement at baseline, 12 week and 24 week
Title
Hypoglycemia event
Description
documented hypoglycemia (glucose monitor <70mg/dl with hypoglycemia associated symptoms) from baseline to week 24
Time Frame
recorded at 12 week and 24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Hong Zeng, MD
Phone
+886-975835827
Email
starrydouchain@yahoo.com.tw
Facility Information:
Facility Name
Division of Endocrinology and Metabolism, Department of Internal Medicine, Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Hong Zeng, MD
Phone
+886-2-25433535
Ext
2174
Email
starrydouchain@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Sung-Chen Liu, MD
First Name & Middle Initial & Last Name & Degree
Chun-Chuan Lee, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
36224294
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.
Results Reference
derived
PubMed Identifier
32827752
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.
Results Reference
derived

Learn more about this trial

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

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