Pioglitazone and SGLT2 Inhibitors vs. DPP4 Inhibitors in Patients With Stroke

NCT ID: NCT04419337

Last Updated: 2023-03-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-15
• Study Completion Date: 2024-01-31

Brief Summary

Introduction: An optimal combination of antidiabetic drugs for diabetic patients with ischemic stroke is not well-established. The objective of this randomized trial is to evaluate whether combination of pioglitazone and a sodium glucose cotransporter 2 (SGLT-2) inhibitor, compared with a dipeptidyl peptidase-4 (DPP-4) inhibitor, reduces recurrent stroke in diabetic patients with recent ischemic stroke.

Methods and analysis: The trial is a randomized, parallel-group study conducted at 7 hospitals in Taiwan. Inclusion criteria are adult patients with a history of ischemic stroke within 3 months, diabetes mellitus with Hba1C > 7%, taking metformin currently or previously, and estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2. Eligible patients who sign the informed consent forms will be randomly assigned in a 1:1 ratio to receive either combination of pioglitazone and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) vs. a DPP4 inhibitor. Primary outcome is change in HbA1C between 6 months and baseline in active vs comparator groups. Additional biomarker outcomes are change in hs-CRP insulin resistance, B type natriuretic peptide, and urine albumin creatinine ratio between 6 months and baseline.

Ethics and dissemination Study protocol was approved by the Institutional Review Board of Chang Gung Memorial Hospital, Chiayi Branch, Taiwan (201702353A3, 201802340A3 and 201902176A3). All participants will be required to sign and date an informed consent form. Study findings will be disseminated via a peer-reviewed journal.

Conditions

Diabetes Mellitus; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active arm

metformin+pioglitazone+an SGLT2 inhibitor

Group Type: EXPERIMENTAL

Metformin plus Pioglitazone plus an SGLT2 inhibitor

Intervention Type: DRUG

Patients assigned to active group will stop their prior oral antidiabetic drugs and receive combination of metformin, pioglitazone, and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) and dose will be adjusted by their physicians.

Control arm

metformin + DPP4 inhibitors

Group Type: ACTIVE_COMPARATOR

Metformin plus Pioglitazone plus an SGLT2 inhibitor

Intervention Type: DRUG

Patients assigned to active group will stop their prior oral antidiabetic drugs and receive combination of metformin, pioglitazone, and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) and dose will be adjusted by their physicians.

Interventions

Metformin plus Pioglitazone plus an SGLT2 inhibitor

Patients assigned to active group will stop their prior oral antidiabetic drugs and receive combination of metformin, pioglitazone, and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) and dose will be adjusted by their physicians.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Ischemic stroke within 3 months of randomization

2. Type 2 diabetes mellitus and Hba1C > 7.0% and under metformin therapy currently or previously

3. Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2

4. Age ≥ 20 y at study entry

5. Ability and willingness to provide informed consent

Exclusion Criteria

1. History of congestive heart failure (NYHA class 1-4)

2. History of bladder cancer

3. History of repeated (> 2 episodes) urinary tract infection or genital tract infection

4. Irreversible medical conditions with predicted survival < 1 years

5. Current use of an insulin

6. Current use of a glucagon-like peptide-1 receptor agonist

7. Current use of pioglitazone or an SGLT-2 inhibitor

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: collaborator

Chiayi Christian Hospital

OTHER

Sponsor Role: collaborator

Tainan Sin-lau Hospital

UNKNOWN

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Chiayi Branch

Locations

Chang Gung Memorial Hospital, Chiayi Branch

Chiayi City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Meng Lee, MD

Role: CONTACT

menlee5126@gmail.com

8863621000 ext. 2806

Facility Contacts

Meng Lee, MD

Role: primary

menglee5126@gmail.com

88653621000 ext. 2806

Other Identifiers

MOST 108-2314-B-182-017-

Identifier Type: -

Identifier Source: org_study_id