Type 2 Diabetes MellitusPhase 4NCT02791035
Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin
A Phase 4 study testing Oral administration of Ipragliflozin in people with Type 2 Diabetes Mellitus, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to examine the correlation between change of HbA1c, urinary glucose excretion and other factors when ipragliflozin is added to preexisting therapy in subjects with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Oral administration of Ipragliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2016to Mar 2017
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject who has written informed consent
- Subjects who are diagnosed as type 2 diabetes mellitus
- Subjects who are 20 to 70 years old
- Subjects on a stable diet and exercise at least 8 weeks prior to the study participation
- Stable doses of the following medications for 8 weeks or more but, HbA1c level of 7.0 to 9.5% (Metformin, Metformin + SU, Metformin + DPP-4 inhibitor, Metformin + TZD, TZD, TZD + SU, TZD + DPP-4 inhibitor, SU, SU + DPP-4 inhibitor, DPP-4 inhibitor)
Who cannot join
- Type 1 DM
- Gestational DM
- Diabetic ketoacidosis
- CKD stage 3B-5 (eGFR 45)
- Severe infection, serious trauma, or perioperative period
- Known or suspected hypersensitivity to ipragliflozin
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- Symptomatic urogenital infection
- Chemotherapy or radiation therapy for malignant tumor or diagnosis of malignant tumor within 5 years (except for thyroid cancer)
- Under the therapeutic intervention and/or another clinical study using IP drug
- Hepatic disease ( 3 times of upper normal limit of AST or ALT)
- Serious voiding difficulty due to neurogenic bladder or prostate hyperplasia
- Drugs not allowed for concomitant use
- Alpha glucosidase inhibitor or meglitinide within 60 days prior to screening
- Insulin within 60 days prior to screening
- Systemic steroid use (PO, IV or IM) over 2 weeks within 3 months prior to screening
- Inhalation or pleural intracavitary injection of steroid known as having high systemic absorption rate
- GLP-1 agonist (except for exenatide) within 60 days prior to screening
- Heart failure (NYHA class III-IV) or uncontrolled arrhythmia within 6 months prior to screening
- Cardiovascular diseases (unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass graft, or percutaneous coronary intervention) within 3 months prior to screening
- Subjects who are not eligible to the study according to an investigator's decision
- Inability to read the consent form
- Pregnancy, lactation, or plan to get pregnant during the study period
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the correlation between change of HbA1c, urinary glucose excretion and other factors when ipragliflozin is added to preexisting therapy in subjects with type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Oral administration of Ipragliflozin
- 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.
Oral administration of IpragliflozinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ipragliflozin | Experimental | Ipragliflozin 50 mg/tablet, orally, 1 tablet once daily for 12 weeks Receives: Drug: Oral administration of Ipragliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between change of HbA1c and urinary glucose excretion
Measured: Baseline and week 12
Secondary outcomes (6)
Correlation between reduction in HbA1c and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)
Measured: Baseline and week 12
Correlation between increase in urinary glucose excretion and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)
Measured: Baseline and week 12
Change of HbA1c
Measured: Baseline and week 12
Chang e of fasting glucose
Measured: Baseline and week 12
Change of waist circumference
Measured: Baseline and week 12
Percentage of subjects achieving the target HbA1c(<6.5%)
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2017
- Study completionMar 2017
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.
- More trials run by Asan Medical CenterThe 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Severance Hospital, Samsung Medical Center, Kyung Hee University Hospital at Gangdong, Astellas Pharma Korea, Inc.
- Responsible party
- Principal investigator, WOO JE LEE, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02791035
- Sponsor's protocol ID
- AMC 2016-0100
- Status last verified
- Jul 2017
- First submitted
- 27 May 2016
- Last updated
- 5 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Change of HbA1c, Urinary Glucose Excretion and Other Factors in Patients Treated With Ipragliflozin
- ClinicalTrials.gov ID
- NCT02791035
- Acronym / sponsor ID
- AMC 2016-0100
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Severance Hospital, Samsung Medical Center, Kyung Hee University Hospital at Gangdong, Astellas Pharma Korea, Inc.
- Study start
- Jun 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 6 Jun 2016 (estimated)
- 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.
The purpose of this study is to examine the correlation between change of HbA1c, urinary glucose excretion and other factors when ipragliflozin is added to preexisting therapy in subjects with type 2 diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipragliflozin | Experimental | Drug: Oral administration of IpragliflozinIpragliflozin 50 mg/tablet, orally, 1 tablet once daily for 12 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject who has written informed consent
- Subjects who are diagnosed as type 2 diabetes mellitus
- Subjects who are 20 to 70 years old
- Subjects on a stable diet and exercise at least 8 weeks prior to the study participation
- Stable doses of the following medications for 8 weeks or more but, HbA1c level of 7.0 to 9.5% (Metformin, Metformin + SU, Metformin + DPP-4 inhibitor, Metformin + TZD, TZD, TZD + SU, TZD + DPP-4 inhibitor, SU, SU + DPP-4 inhibitor, DPP-4 inhibitor)
Key exclusion criteria (22 listed)
- Type 1 DM
- Gestational DM
- Diabetic ketoacidosis
- CKD stage 3B-5 (eGFR 45)
- Severe infection, serious trauma, or perioperative period
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 |
|---|---|---|
| Oral administration of Ipragliflozin | Drug | Ipragliflozin |
Primary outcome
Correlation between change of HbA1c and urinary glucose excretion
Time frame: Baseline and week 12
6 secondary outcomes
Correlation between reduction in HbA1c and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)
Time frame: Baseline and week 12
Correlation between increase in urinary glucose excretion and various parameters (HOMA-IR, HOMA-ß, insulinogenic index)
Time frame: Baseline and week 12
Change of HbA1c
Time frame: Baseline and week 12
Chang e of fasting glucose
Time frame: Baseline and week 12
Change of waist circumference
Time frame: Baseline and week 12
Percentage of subjects achieving the target HbA1c(<6.5%)
Time frame: week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral administration of Ipragliflozin in people with Type 2 Diabetes Mellitus, run by Asan Medical Center at 1 site 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 5 inclusion and 22 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: finished, as of the sponsor's last update on 5 Jul 2017. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between change of HbA1c and urinary glucose excretion (time frame: Baseline and week 12). 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 5 Jul 2017.