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Comparison of Dapagliflozin, Lobeglitazone, and Its Combination in Efficacy and Safety (Location-F)

Primary Purpose

Diabetes Type 2

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dapagliflozin 10mg Tab
Lobeglitazone 0.5 mg
Dapagliflozin + Lobeglitazone
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Type 2 focused on measuring diabetes type 2

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: type 2 diabetic patients between the ages of 20 and 80 who are taking oral diabetes medications (metformin and/or DPP-4 inhibitors) for more than 8 weeks without dose adjustment body mass index (BMI) ≥ 20 kg/m2 eGFR ≥ 50 mL/min/1.73 m2 HbA1c: 7-10%. Exclusion Criteria: patients with type 1 diabetes; HbA1c <7% or HbA1c >10% fasting blood glucose (FPG) >15 mmol/L (270 mg/dL) at the first visit (screening) and pre-randomization screening women of childbearing potential (if not using proper contraception) history of gastric surgery (including gastric banding within 3 years) history of diabetic ketoacidosis or non-ketogenic hyperosmotic coma average of 3 blood pressure measurements is systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >100 mmHg heart failure NYHA class III or IV AST or ALT greater than 3 times the upper limit of normal systemic corticosteroids have been used for 10 consecutive days within 90 days (topical, eye drop, topical or inhalation agents)

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Dapagliflozin

Lobeglitazone

Dapagliflozin and Lobeglitazone combined

Arm Description

Dapagliflozin 10 mg once daily will be given to participants.

Lobeglitazone 0.5 mg once daily will be given to participants.

Dapagliflozin 10 mg and lobeglitazone 0.5 mg once daily together will be given to participants.

Outcomes

Primary Outcome Measures

HbA1c
Glycemic control

Secondary Outcome Measures

Fasting plasma glucose
Glucose metabolism
Postprandial glucose
Glucose metabolism
Whole body muscle
Body composition
Whole body fat
Body composition
Abdominal subcutaneous fat
Body composition
Abdominal visceral fat
Body composition
NTproBNP
Cardiac marker
Troponin T
Cardiac marker
Lipids
Lipid profiles (TG, HDL, and LDL)
Lipoprotein (a)
Lipid metabolism
Urinary microalbumin-Creatinine ratio
Lipid metabolism
Fib-4
Hepatic fibrosis marker

Full Information

First Posted
June 14, 2023
Last Updated
August 10, 2023
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05915949
Brief Title
Comparison of Dapagliflozin, Lobeglitazone, and Its Combination in Efficacy and Safety
Acronym
Location-F
Official Title
Evaluation of the Efficacy of Combination of Dapagliflozin and Lobeglitazone on Glucose Concentrations and Body Fat in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

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

5. Study Description

Brief Summary
Diabetes is the most frequently occurring chronic disease along with obesity, hypertension, and hyperlipidemia. The number of patients with diabetes is increasing worldwide. Despite rapid progress in management of diabetes, the problem is that glycemic target goal is still low showing 30-40%. Thus, diabetes has become a serious social, economic, and public health problem beyond individual health problems due to its increasing prevalence.
Detailed Description
Previously, metformin, sulfonylurea, and insulin injections were used to treat diabetes, but since then, various new drugs such as thiazolidinedione (TZD), sodium-glucose cotransporter-2 (SGLT-2) inhibitor, dipeptidyl peptidase-4 (DPP-4) inhibitor, and glucagon like peptide-1 (GLP-1) receptor agonist have been released. Among them, metformin and TZD are known to improve insulin resistance, SGLT-2 inhibitor has a mechanism to excrete glucose into urine, and other drugs have a mechanism to promote insulin secretion. After a report in 2007 that rosiglitazone could increase cardiovascular disease, use of TZD has been limited. However, more people are having insulin resistance, and this is more evident in developing countries. In this circumstance, TZD can be a main stay for diabetic patients with insulin resistance. TZDs improve insulin sensitivity by activating peroxisome proliferator-activated receptor γ (PPARγ). They have shown excellent glycemic durability. On the other hand, SGLT-2 inhibitors are attracting attention as a mechanism that directly excretes excess glucose in diabetic patients through urine. Many cardiovascular outcome trials have proven its efficacy in cardiovascular and renal outcomes. Current guidelines proposed a new paradigm in the management of T2DM, with a preferential place for SGLT-2 inhibitors, after metformin, in patients with atherosclerotic cardiovascular disease, heart failure and progressive kidney disease. As such, combination therapy of TZD and SGLT-2 inhibitors, two drugs that have mechanisms for improving insulin resistance and urinary glucose excretion, would have compensatory effects, which would be effective for diabetes treatment. In addition, since studies that investigated effect of TZD and SGLT-2 inhibitor combination on changes in body fat mass and metabolic phenotype are lacking, we investigated the effect of reducing visceral fat (abdominal visceral fat mass/abdominal subcutaneous fat mass) in combination therapy with dapagliflozin, an SGLT-2 inhibitor, and lobeglitazone, a TZD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2
Keywords
diabetes type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dapagliflozin
Arm Type
Experimental
Arm Description
Dapagliflozin 10 mg once daily will be given to participants.
Arm Title
Lobeglitazone
Arm Type
Active Comparator
Arm Description
Lobeglitazone 0.5 mg once daily will be given to participants.
Arm Title
Dapagliflozin and Lobeglitazone combined
Arm Type
Active Comparator
Arm Description
Dapagliflozin 10 mg and lobeglitazone 0.5 mg once daily together will be given to participants.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin 10mg Tab
Other Intervention Name(s)
Forxiga 10mg
Intervention Description
Forxiga 10mg Tab once daily will be given to participants for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Lobeglitazone 0.5 mg
Other Intervention Name(s)
Duvie 0.5 mg
Intervention Description
Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Dapagliflozin + Lobeglitazone
Other Intervention Name(s)
Forxiga 10mg + Duvie 0.5mg
Intervention Description
Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.
Primary Outcome Measure Information:
Title
HbA1c
Description
Glycemic control
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Fasting plasma glucose
Description
Glucose metabolism
Time Frame
6 months
Title
Postprandial glucose
Description
Glucose metabolism
Time Frame
6 months
Title
Whole body muscle
Description
Body composition
Time Frame
6 months
Title
Whole body fat
Description
Body composition
Time Frame
6 months
Title
Abdominal subcutaneous fat
Description
Body composition
Time Frame
6 months
Title
Abdominal visceral fat
Description
Body composition
Time Frame
6 months
Title
NTproBNP
Description
Cardiac marker
Time Frame
6 months
Title
Troponin T
Description
Cardiac marker
Time Frame
6 months
Title
Lipids
Description
Lipid profiles (TG, HDL, and LDL)
Time Frame
6 months
Title
Lipoprotein (a)
Description
Lipid metabolism
Time Frame
6 months
Title
Urinary microalbumin-Creatinine ratio
Description
Lipid metabolism
Time Frame
6 months
Title
Fib-4
Description
Hepatic fibrosis marker
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Side effects.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: type 2 diabetic patients between the ages of 20 and 80 who are taking oral diabetes medications (metformin and/or DPP-4 inhibitors) for more than 8 weeks without dose adjustment body mass index (BMI) ≥ 20 kg/m2 eGFR ≥ 50 mL/min/1.73 m2 HbA1c: 7-10%. Exclusion Criteria: patients with type 1 diabetes; HbA1c <7% or HbA1c >10% fasting blood glucose (FPG) >15 mmol/L (270 mg/dL) at the first visit (screening) and pre-randomization screening women of childbearing potential (if not using proper contraception) history of gastric surgery (including gastric banding within 3 years) history of diabetic ketoacidosis or non-ketogenic hyperosmotic coma average of 3 blood pressure measurements is systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >100 mmHg heart failure NYHA class III or IV AST or ALT greater than 3 times the upper limit of normal systemic corticosteroids have been used for 10 consecutive days within 90 days (topical, eye drop, topical or inhalation agents)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minji Sohn, PhD
Phone
82-031-787-7041
Email
65423@snuhb.org
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, PHD
Phone
82-31-787-7035
Email
limsoo@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, PHD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparison of Dapagliflozin, Lobeglitazone, and Its Combination in Efficacy and Safety

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