Metabolic and Cardiovascular Effects of Dipeptidyl Peptidase-4 (DPP-4) or Sodium-glucose Co-transporter Type 2 (SGLT2) Inhibitors
Primary Purpose
Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
DPP-4 inhibiotors
SGLT2 inhibitors
Glimepiride
Sponsored by
About this trial
This is an interventional treatment trial for Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of type 2 diabetic patients
- Must be able to swallow tablets
- never received DPP-4 inhibitors or SGLT2 inhibitors
Exclusion Criteria:
- uncontrolled diabetes (fasting plasma glucose>200 mg/dL)
- receiving insulin therapy
- hepatic disorders (2.5 fold or greater increases in aspartate transaminase or alanine transaminase levels above the upper limits of normal)
- inflammatory disorders
- neoplastic disorders
- recent (<3months) acute coronary syndrome and stroke
- any acute infection
Sites / Locations
- Kurume University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
DPP-4 inhibitors
SGLT2 inhibitors
Glimepiride
Arm Description
sitagliptin (25-100mg daily), vildagliptin (50-100mg daily), alogliptin (12.5-25mg daily), linagliptin (2.5-5mg daily), teneligliptin (20-40mg), anagliptin (100-200mg daily), saxagliptin (2.5-5mg daily) or trelagliptin (50-100mg weekly)
ipragliflozin (50-100mg daily), dapagliflozin (5-10mg daily), luseogliflozin (2.5-5mg), tofogliflozin (20mg daily), canagliflozin (100mg daily) or empagliflozin (10-25mg daily)
glimepiride (0.5-8mg daily)
Outcomes
Primary Outcome Measures
Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index
Secondary Outcome Measures
Change from baseline in subcutaneous and visceral fat volume
Change from baseline in lipid profile including malondialdehyde-modified low-density lipoprotein and remnant-like particle cholesterol
Change from baseline in circulating inflammatory markers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02528019
Brief Title
Metabolic and Cardiovascular Effects of Dipeptidyl Peptidase-4 (DPP-4) or Sodium-glucose Co-transporter Type 2 (SGLT2) Inhibitors
Official Title
Effects of the DPP-4 or SGLT2 Inhibitors on the Metabolic Cardiovascular Systems in Patients With Type 2 Diabetes Mellitus.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kurume University
4. Oversight
5. Study Description
Brief Summary
Inhibition of dipeptidyl peptidase-4 (DPP-4) or sodium-glucose co-transporter type 2 (SGLT2) has been proposed as a therapeutic target for type 2 diabetes. However, how DPP-4 inhibitors or SGLT2 inhibitors exert protective actions for diabetic complications in addition to their glucose-lowering effects remains unknown.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of the DPP-4 Inhibitors or SGLT2 Inhibitors on the Protective Actions for Diabetic Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DPP-4 inhibitors
Arm Type
Active Comparator
Arm Description
sitagliptin (25-100mg daily), vildagliptin (50-100mg daily), alogliptin (12.5-25mg daily), linagliptin (2.5-5mg daily), teneligliptin (20-40mg), anagliptin (100-200mg daily), saxagliptin (2.5-5mg daily) or trelagliptin (50-100mg weekly)
Arm Title
SGLT2 inhibitors
Arm Type
Active Comparator
Arm Description
ipragliflozin (50-100mg daily), dapagliflozin (5-10mg daily), luseogliflozin (2.5-5mg), tofogliflozin (20mg daily), canagliflozin (100mg daily) or empagliflozin (10-25mg daily)
Arm Title
Glimepiride
Arm Type
Active Comparator
Arm Description
glimepiride (0.5-8mg daily)
Intervention Type
Drug
Intervention Name(s)
DPP-4 inhibiotors
Intervention Type
Drug
Intervention Name(s)
SGLT2 inhibitors
Intervention Type
Drug
Intervention Name(s)
Glimepiride
Primary Outcome Measure Information:
Title
Effects of treatment on the nominal change in arterial stiffness from baseline after 6 months of treatment as measured by cardio-ankle vascular index
Time Frame
6 months of treatment
Secondary Outcome Measure Information:
Title
Change from baseline in subcutaneous and visceral fat volume
Time Frame
6 months of treatment
Title
Change from baseline in lipid profile including malondialdehyde-modified low-density lipoprotein and remnant-like particle cholesterol
Time Frame
6 months of treatment
Title
Change from baseline in circulating inflammatory markers
Time Frame
6 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of type 2 diabetic patients
Must be able to swallow tablets
never received DPP-4 inhibitors or SGLT2 inhibitors
Exclusion Criteria:
uncontrolled diabetes (fasting plasma glucose>200 mg/dL)
receiving insulin therapy
hepatic disorders (2.5 fold or greater increases in aspartate transaminase or alanine transaminase levels above the upper limits of normal)
inflammatory disorders
neoplastic disorders
recent (<3months) acute coronary syndrome and stroke
any acute infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nobuhiro Tahara, MD, PhD
Phone
+81-942-31-7580
Email
ntahara@med.kurume-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nobuhiro Tahara, MD, PhD
Organizational Affiliation
Department of Medicine, Division of Cardiovascular Medicine, Kurume University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Kurume University Hospital
City
Kurume city
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nobuhiro Tahara, MD, PhD
Phone
+81-942-31-7580
Email
ntahara@med.kurume-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Sho-ichi Yamagishi, MD, PhD
Phone
+81-942-31-7562
First Name & Middle Initial & Last Name & Degree
Nobuhiro Tahara, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
29766812
Citation
Bekki M, Tahara N, Tahara A, Igata S, Honda A, Sugiyama Y, Nakamura T, Sun J, Kumashiro Y, Matsui T, Fukumoto Y, Yamagishi SI. Switching Dipeptidyl Peptidase-4 Inhibitors to Tofogliflozin, a Selective Inhibitor of Sodium-Glucose Cotransporter 2 Improve Arterial Stiffness Evaluated by Cardio-Ankle Vascular Index in Patients with Type 2 Diabetes: A Pilot Study. Curr Vasc Pharmacol. 2019;17(4):411-420. doi: 10.2174/1570161116666180515154555.
Results Reference
derived
Learn more about this trial
Metabolic and Cardiovascular Effects of Dipeptidyl Peptidase-4 (DPP-4) or Sodium-glucose Co-transporter Type 2 (SGLT2) Inhibitors
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