Diabetes MellitusPhase 2NCT04419337
Pioglitazone and SGLT2 Inhibitors vs. DPP4 Inhibitors in Patients With Stroke
A Phase 2 study testing Metformin plus Pioglitazone plus an SGLT2 inhibitor in people with Diabetes Mellitus and Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Diabetes Mellitus, Stroke
- What is being tested?
- Metformin plus Pioglitazone plus an SGLT2 inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Sep 2019to 31 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital, Chiayi Branch
Chiayi City, 613
Meng Lee, MD, 88653621000 ext. 2806, menglee5126@gmail.com
About this study
Official title: Comparison of Combined Pioglitazone and SGLT2 Inhibitors vs. DPP4 Inhibitors in Diabetic Patients With Ischemic Stroke: Rationale and Study Design
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
- Being tested
- Metformin plus Pioglitazone plus an SGLT2 inhibitor
- Keywords
- stroke, diabetes mellitus, sodium-glucose transport protein 2 inhibitor, pioglitazone
- Medical subject headings
- Diabetes Mellitus, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin plus Pioglitazone plus an SGLT2 inhibitorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Active arm | Experimental | metformin+pioglitazone+an SGLT2 inhibitor Receives: Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitor |
| Control arm | Active comparator | metformin + DPP4 inhibitors Receives: Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C
blood test to evaluate glycemic control
Measured: 6 months from baseline in active vs control arms
Secondary outcomes (4)
UACR
to evaluate microalbuminuria
Measured: 6 months from randomization in active vs control arms
hs-CRP
to evaluate hs-CRP in active vs control arms
Measured: 6 months from randomization
NT-proBNP
to evaluate NT-proBNP in active vs control arms
Measured: 6 months from randomization
insulin resistance
Insulin resistance will be evaluated by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measured: 6 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start15 Sep 2019
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Chiayi Christian Hospital, Tainan Sin-lau Hospital
- Responsible party
- Sponsor
- Investigators
- Meng Lee, MD, Principal investigator, Chang Gung Memorial Hospital, Chiayi Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419337
- Sponsor's protocol ID
- MOST 108-2314-B-182-017-
- Status last verified
- Mar 2023
- First submitted
- 26 Feb 2020
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Combined Pioglitazone and SGLT2 Inhibitors vs. DPP4 Inhibitors in Diabetic Patients With Ischemic Stroke: Rationale and Study Design
- ClinicalTrials.gov ID
- NCT04419337
- Acronym / sponsor ID
- MOST 108-2314-B-182-017-
- Conditions
- Diabetes Mellitus, Stroke
- Keywords
- stroke, diabetes mellitus, sodium-glucose transport protein 2 inhibitor, pioglitazone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Chiayi Christian Hospital, Tainan Sin-lau Hospital
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm | Experimental | Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitormetformin+pioglitazone+an SGLT2 inhibitor |
| Control arm | Active comparator | Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitormetformin + DPP4 inhibitors |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin plus Pioglitazone plus an SGLT2 inhibitorPatients 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. | Drug | Active arm, Control arm |
Primary outcome
HbA1C
Time frame: 6 months from baseline in active vs control arms
blood test to evaluate glycemic control
4 secondary outcomes
UACR
Time frame: 6 months from randomization in active vs control arms
hs-CRP
Time frame: 6 months from randomization
NT-proBNP
Time frame: 6 months from randomization
insulin resistance
Time frame: 6 months from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng Lee, MD principal investigator
Chang Gung Memorial Hospital, Chiayi Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin plus Pioglitazone plus an SGLT2 inhibitor in people with Diabetes Mellitus and Stroke, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meng Lee, MD (8863621000 ext. 2806, menlee5126@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C (time frame: 6 months from baseline in active vs control arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.