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

NCT04419337 | Unknown Phase 2

• 1 other identifier: MOST 108-2314-B-182-017-
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

stroke; diabetes mellitus; sodium-glucose transport protein 2 inhibitor; pioglitazone

Outcome Measures

Primary Outcomes (1)

• HbA1C

  blood test to evaluate glycemic control

  6 months from baseline in active vs control arms

Secondary Outcomes (4)

• UACR

  6 months from randomization in active vs control arms

• hs-CRP

  6 months from randomization

• NT-proBNP

  6 months from randomization

• insulin resistance

  6 months from randomization

Study Arms (2)

Active arm

EXPERIMENTAL

metformin+pioglitazone+an SGLT2 inhibitor

Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitor

Control arm

ACTIVE COMPARATOR

metformin + DPP4 inhibitors

Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitor

Interventions

Metformin plus Pioglitazone plus an SGLT2 inhibitor 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.

Active arm; Control arm

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic stroke within 3 months of randomization
• Type 2 diabetes mellitus and Hba1C \> 7.0% and under metformin therapy currently or previously
• Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73 m2
• Age ≥ 20 y at study entry
• Ability and willingness to provide informed consent

You may not qualify if:

• History of congestive heart failure (NYHA class 1-4)
• History of bladder cancer
• History of repeated (\> 2 episodes) urinary tract infection or genital tract infection
• Irreversible medical conditions with predicted survival \< 1 years
• Current use of an insulin
• Current use of a glucagon-like peptide-1 receptor agonist
• Current use of pioglitazone or an SGLT-2 inhibitor

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Taiwan University Hospital: collaborator
• Chiayi Christian Hospital: collaborator
• Tainan Sin-lau Hospital: collaborator

Study Sites (1)

Chang Gung Memorial Hospital, Chiayi Branch

Chiayi City, 613, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Stroke

Interventions

Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Meng Lee, MD

  Chang Gung Memorial Hospital, Chiayi Branch

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meng Lee, MD

CONTACT

8863621000; menlee5126@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: June 5, 2020
• Study Start: September 15, 2019
• Primary Completion: July 31, 2023
• Study Completion: January 31, 2024
• Last Updated: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)