Pioglitazone and SGLT2 Inhibitors vs. DPP4 Inhibitors in... | NCT04419337

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

NCT04419337

Sponsor

Chang Gung Memorial Hospital

Status

Unknown status

Last Update Posted

Mar 30, 2023Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

Diabetes Mellitus
Stroke

Interventions

Metformin plus Pioglitazone plus an SGLT2 inhibitor

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2019Actual

Primary Completion Date

Jul 31, 2023Estimated

Completion Date

Jan 31, 2024Estimated

First Submitted Date

Feb 26, 2020

First Submission Date that Met QC Criteria

Jun 3, 2020

First Posted Date

Jun 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2023

Last Update Posted Date

Mar 30, 2023Actual

Name	Class
National Taiwan University Hospital	OTHER
Chiayi Christian Hospital	OTHER
Tainan Sin-lau Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HbA1C	blood test to evaluate glycemic control	6 months from baseline in active vs control arms

Secondary Outcomes

Measure	Description	Time Frame
UACR	to evaluate microalbuminuria	6 months from randomization in active vs control arms
hs-CRP	to evaluate hs-CRP in active vs control arms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Meng Lee, MD	Contact	8863621000	2806	menlee5126@gmail.com

Overall Officials

Name	Affiliation	Role
Meng Lee, MD	Chang Gung Memorial Hospital, Chiayi Branch	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung Memorial Hospital, Chiayi Branch	Recruiting	Chiayi City		613	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D020521	Stroke

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008687	Metformin
D000077205	Pioglitazone

Ancestor Terms

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D045162

Browse Leaves

Not provided

Browse Branches

Not provided