Type 2 Diabetes MellitusPhase 4NCT03118713

A Study to Evaluate the Renal Protective Effect (Urine Albumin-to-Creatinine Ratio (UACR)), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria

A Phase 4 study testing metformin, ipragliflozin and glimepiride in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Korea, Inc. at 8 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 19 to 74 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: metformin, ipragliflozin and glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 8 sitesSouth Korea
Study dates: 25 Apr 2017to 12 Dec 2018
Phase: Phase 4
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 19 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject who is outpatient.
Subject who has been diagnosed with type 2 diabetes mellitus.
Subject who has been on a stable dose of at least 1000 mg/day metformin monotherapy for at least 8 weeks (56 days) prior to Visit 1.
Subject who has an HbA1C value between 7.0% and 9.0% at Visit 1.
Subject who has a urinary albumin/creatinine ratio greater than or equal to 30 mg/g at Visit 1.
Subject who has eGFR greater than or equal to 45 mL/min/1.73 m^2.
Subject is on stable diet and exercise program for at least 8 weeks (56 days) prior to Visit 1.
Subject who has a urinary albumin/creatinine ratio greater than or equal to 30 mg/g at Visit 2.

Who cannot join

Subject who has been diagnosed with type 1 diabetes mellitus.
Subject who started or has changed the types and/or dosage of Renin Angiotensin System (RAS) inhibitors (Angiotensin II Receptor Blockers (ARBs), ACE inhibitors) within 12 weeks prior to Visit 1.
Subject who has been treated with Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors within 12 weeks prior to Visit 1.
Subject who has a history of clinically significant renal disease(s) (other than diabetic nephropathy) such as renovascular occlusive disease, nephrectomy, or renal transplant.
Subject who has a diabetic ketoacidosis, or history of diabetic ketoacidosis.
Subject with diabetic coma or precoma.

Show all 19Show fewer

Subject with severe infection, serious trauma, or perioperative subject at Visit 1
Subject who has a history of hypersensitivity to ipragliflozin or glimepiride or other SGLT-2 inhibitors or sulfonylureas.
Subject has Aspartate Aminotransferase (GOT) (AST) or Alanine Aminotransferase (GPT) (ALT) value exceeding 3 times of upper limit of the normal range, or total bilirubin value exceeding 3 times of upper limit of the normal range at Visit 1.
Subject has progressive proliferative diabetic retinopathy.
Subject has a symptomatic urinary tract infection or genital infection at Visit 1.
Subject has uncontrollable psychiatric disorder(s) with medication.
Subject abuses drug or alcohol at Visit 1.
Subject has lactic acidosis or has history of lactic acidosis.
Subject who has been known to have Hepatitis B, Hepatitis C or Positive Human immunodeficiency virus (HIV).
Subject is unable or unwilling to adhere to any of the protocol requirements such as hospital visits and dose instruction specified in this study.
Subject with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Subject has participated in another interventional study with study drugs within 12 weeks prior to obtaining written informed consent.
Subject has a clinical condition which would not allow safe conduct of the study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

South Korea8 sites

Site 13
Busan
Site 02
Deagu
Site 11
Guri-si
Site 01
Seoul
Site 05
Seoul
Site 07
Seoul
Site 09
Seoul
Site 12
Suwon

Other trials in South Korea

About this study

Official title: A Phase 4, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Renal Protective Effect (UACR), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria

The primary purpose of this study is to assess the renal protective effect of ipragliflozin in combination with metformin on the percent change of UACR from baseline to 24 weeks against glimepiride in combination with metformin in type 2 diabetes mellitus patients with albuminuria. The secondary purpose of this study is to assess the efficacy, safety and impact on quality of life (QoL) of ipragliflozin in combination with metformin against glimepiride in combination with metformin in type 2 diabetes mellitus patients with albuminuria.

Read the detailed description

This is a multicenter study that will compare ipragliflozin/metformin with glimepiride/metformin in the treatment of type 2 diabetes mellitus (T2DM) with albuminuria.

The study will include screening and 24-week treatment period. Subjects entering the study have been on a stable dose of at least 1000 mg/day metformin monotherapy for at least 8 weeks (56 days) prior to Visit 1. For randomization, subject will be stratified by the site and the administration of renin-angiotensin system inhibitors (angiotensin receptor blockers and/or angiotensin-converting-enzyme inhibitors) at Visit 2. Subjects will be centrally randomized to either ipragliflozin/metformin group or glimepiride/metformin group and receive 24-week treatment by each group

Conditions: Type 2 Diabetes Mellitus
Being tested: metformin, ipragliflozin, glimepiride
Keywords: Metformin, Ipragliflozin, Type 2 Diabetes Mellitus, ASP1941, Glimepiride
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

metforminDrug
Also called Fortamet, Riomet, Glucophage, Diabex XR
oral
ipragliflozinDrug
Also called ASP1941, Suglat
oral
glimepirideDrug
Also called Amaryl
oral

Study groups in NCT03118713
Study group	Role	What they receive
ipragliflozin and metformin	Experimental	Subjects will receive daily dosage of ipragliflozin and metformin as single tablets Receives: Drug: metformin; Drug: ipragliflozin
glimepiride and metformin	Experimental	Subjects will receive daily dosage of glimepiride and metformin as single tablets Receives: Drug: metformin; Drug: glimepiride

What is being measured

The primary outcome is the main question the study is designed to answer.

The percentage of change of Urine Albumin-to-Creatinine Ratio (UACR)
Early morning urinary sample will be collected for the test
Measured: Baseline up to 24 weeks

Secondary outcomes (10)

The percentage of patients whose UACR level is normalized or improved more than 50%
Early morning urinary sample will be collected for the test
Measured: Baseline up to 24 weeks
Change from baseline in Estimated glomerular filtration rate (e-GFR)
Test parameter e-GFR shall be measured at the local laboratory
Measured: Baseline up to 24 weeks
Change from baseline in Hemoglobin A1c (HbA1c)
Test parameter HbA1c shall be measured at the local laboratory
Measured: Baseline up to 24 weeks
Change from baseline in Fasting Plasma Glucose (FPG)
Test parameter FPG shall be measured at the local laboratory
Measured: Baseline up to 24 weeks
Change from baseline in body weight
Body Weight shall be measured by the same scale for the clinical trial period
Measured: Baseline up to 24 weeks
Change from baseline in blood pressure
Blood pressure will be measured two times with 1-2 minutes interval by the same arm and procedure during the study
Measured: Baseline up to 24 weeks
Change from baseline in Uric Acid
Test parameter Uric Acid shall be measured at the local laboratory
Measured: Baseline up to 24 weeks
Change from baseline in health status as measured through EuroQol 5 Dimension 5 Level Health State Utility Index (EQ-5D-5L) questionnaire
The EQ-5D-5L Questionnaire consists of 5 domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression
Measured: Baseline up to 24 weeks
Change from baseline in health status as measured through EuroQol-Visual Analogue Scale (EQ VAS) questionnaire
The EQ VAS measures the score (0 to 100) of change from baseline to 24 weeks
Measured: Baseline up to 24 weeks
Change from baseline in Quality of Life as measured through Audit of Diabetes-Dependent Quality of Life-19 (ADDQoL-19) questionnaire
Quality of Life will be assessed through ADDQoL-19. Patients will be asked to complete the questionnaires at visit 2 and 5
Measured: Baseline up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Apr 201712 Dec 2018

First posted18 Apr 2017
Study start25 Apr 2017
Primary completion12 Dec 2018
Study completion12 Dec 2018

Why it stopped: Business decision due to enrollment challenges

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03118713
Sponsor's protocol ID: 1941-MA-3122-KR
Status last verified: Nov 2024
First submitted: 13 Apr 2017
Last updated: 8 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Renal Protective Effect (UACR), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria
ClinicalTrials.gov ID: NCT03118713
Acronym / sponsor ID: 1941-MA-3122-KR
Conditions: Type 2 Diabetes Mellitus
Keywords: Metformin, Ipragliflozin, Type 2 Diabetes Mellitus, ASP1941, Glimepiride
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision due to enrollment challenges
Enrolment: 33 participants (actual)
Lead sponsor: Astellas Pharma Korea, Inc.Industry (pharma, biotech, devices)
Study start: 25 Apr 2017 (actual)
Primary completion: 12 Dec 2018 (actual)
Study completion: 12 Dec 2018 (actual)
First posted: 18 Apr 2017 (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.

Detailed description

This is a multicenter study that will compare ipragliflozin/metformin with glimepiride/metformin in the treatment of type 2 diabetes mellitus (T2DM) with albuminuria.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ipragliflozin and metformin	Experimental	Drug: metformin, Drug: ipragliflozinSubjects will receive daily dosage of ipragliflozin and metformin as single tablets
glimepiride and metformin	Experimental	Drug: metformin, Drug: glimepirideSubjects will receive daily dosage of glimepiride and metformin as single tablets

Who may qualify

Ages: 19 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subject who is outpatient.
Subject who has been diagnosed with type 2 diabetes mellitus.
Subject who has been on a stable dose of at least 1000 mg/day metformin monotherapy for at least 8 weeks (56 days) prior to Visit 1.
Subject who has an HbA1C value between 7.0% and 9.0% at Visit 1.
Subject who has a urinary albumin/creatinine ratio greater than or equal to 30 mg/g at Visit 1.

Key exclusion criteria (19 listed)

Subject who has been diagnosed with type 1 diabetes mellitus.
Subject who started or has changed the types and/or dosage of Renin Angiotensin System (RAS) inhibitors (Angiotensin II Receptor Blockers (ARBs), ACE inhibitors) within 12 weeks prior to Visit 1.
Subject who has been treated with Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors within 12 weeks prior to Visit 1.
Subject who has a history of clinically significant renal disease(s) (other than diabetic nephropathy) such as renovascular occlusive disease, nephrectomy, or renal transplant.
Subject who has a diabetic ketoacidosis, or history of diabetic ketoacidosis.

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
metforminAlso: Fortamet, Riomet, Glucophage, Diabex XRoral	Drug	glimepiride and metformin, ipragliflozin and metformin
ipragliflozinAlso: ASP1941, Suglatoral	Drug	ipragliflozin and metformin
glimepirideAlso: Amaryloral	Drug	glimepiride and metformin

Primary outcome

The percentage of change of Urine Albumin-to-Creatinine Ratio (UACR)
Time frame: Baseline up to 24 weeks
Early morning urinary sample will be collected for the test

10 secondary outcomes

The percentage of patients whose UACR level is normalized or improved more than 50%
Time frame: Baseline up to 24 weeks
Change from baseline in Estimated glomerular filtration rate (e-GFR)
Time frame: Baseline up to 24 weeks
Change from baseline in Hemoglobin A1c (HbA1c)
Time frame: Baseline up to 24 weeks
Change from baseline in Fasting Plasma Glucose (FPG)
Time frame: Baseline up to 24 weeks
Change from baseline in body weight
Time frame: Baseline up to 24 weeks
Change from baseline in blood pressure
Time frame: Baseline up to 24 weeks
Change from baseline in Uric Acid
Time frame: Baseline up to 24 weeks
Change from baseline in health status as measured through EuroQol 5 Dimension 5 Level Health State Utility Index (EQ-5D-5L) questionnaire
Time frame: Baseline up to 24 weeks
Change from baseline in health status as measured through EuroQol-Visual Analogue Scale (EQ VAS) questionnaire
Time frame: Baseline up to 24 weeks
Change from baseline in Quality of Life as measured through Audit of Diabetes-Dependent Quality of Life-19 (ADDQoL-19) questionnaire
Time frame: Baseline up to 24 weeks

Results and safety

The study was stopped early (reason given: Business decision due to enrollment challenges). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Related trials for Type 2 Diabetes Mellitus

Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
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Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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Active, not recruitingPhase 1/2
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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.

Medical Monitor study director

Astellas Pharma Korea, Inc.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing metformin, ipragliflozin and glimepiride in people with Type 2 Diabetes Mellitus, run by Astellas Pharma Korea, Inc. at 8 sites in South Korea.

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 8 inclusion and 19 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: stopped early, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Business decision due to enrollment challenges). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of change of Urine Albumin-to-Creatinine Ratio (UACR) (time frame: Baseline up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03118713.

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 8 Nov 2024.