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

NCT ID: NCT05915949

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-12-31

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.

Conditions

Diabetes Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dapagliflozin

Dapagliflozin 10 mg once daily will be given to participants.

Group Type: EXPERIMENTAL

Dapagliflozin 10mg Tab

Intervention Type: DRUG

Forxiga 10mg Tab once daily will be given to participants for 24 weeks.

Lobeglitazone

Lobeglitazone 0.5 mg once daily will be given to participants.

Group Type: ACTIVE_COMPARATOR

Lobeglitazone 0.5 mg

Intervention Type: DRUG

Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.

Dapagliflozin and Lobeglitazone combined

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

Group Type: ACTIVE_COMPARATOR

Dapagliflozin + Lobeglitazone

Intervention Type: DRUG

Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.

Interventions

Dapagliflozin 10mg Tab

Forxiga 10mg Tab once daily will be given to participants for 24 weeks.

Intervention Type: DRUG

Lobeglitazone 0.5 mg

Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.

Intervention Type: DRUG

Dapagliflozin + Lobeglitazone

Duvie 0.5mg Tab once daily will be given to participants for 24 weeks.

Intervention Type: DRUG

Other Intervention Names

Forxiga 10mg; Duvie 0.5 mg; Forxiga 10mg + Duvie 0.5mg

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soo Lim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Minji Sohn, PhD

Role: CONTACT

65423@snuhb.org

82-031-787-7041

Facility Contacts

Soo Lim, MD, PHD

Role: primary

limsoo@snu.ac.kr

82-31-787-7035

Other Identifiers

B-1910-568-001

Identifier Type: -

Identifier Source: org_study_id