Diabetes Mellitus, Type 2HARUKASNCT02317484
Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes
An observational study of Diabetes Mellitus, Type 2, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II Diabetes under usual care. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Ipragliflozin (SGLT2 inhibitor)
- How many people
- 231 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2014to 28 Feb 2018
- Phase
- Observational
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic and hospital
Who may be able to join
- Diabetes Mellitus, Type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs
- Patients with changes within +- 0.5% of HbA1c
- Patients with the variation of 6.5% =< HbA1C =<10%
- Patients with written informed consents
- Patients whose BMI is =>20kg/m2
Who cannot join
- Patients with Diabetes Mellitus, Type 1, other types of diabetes or pregnancy diabetes
- Patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months
- Patients with severe infection, in the perioperative period or severe trauma
- Patients with moderate renal insufficiency (serum creatinine level: male with greater than or equal to 1.5mg/dL、female with greater than or equal to1.3mg/dL)
- Patients with severe hepatic impairment (judged by the attending doctor)
- Patients with history of requirement of hospitalization for severe cardiovascular event for the last 6 months of consent
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- Patients in pregnancy, breast-feeding, with childbearing potential or plan of pregnancy
- Patients with neuropathic bladder or dysuria
- Patients under treatment with diuretic
- Patients under SGLT2 treatment at the kickoff point of the study
- Patients with a history of hypersensitivity to SGLT2 inhibitors
- Patients who are judged ineligible by the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate clinical efficacy and safety of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II Diabetes under usual care. It is also to investigate and analyze the exploratory influential factor of ipragliflozin treatment on clinical efficacy and safety.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Ipragliflozin (SGLT2 inhibitor)
- 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.
Ipragliflozin (SGLT2 inhibitor)Drug
| Study group | Role | What they receive |
|---|---|---|
| Ipragliflozin (SGLT2 inhibitor) | Not described Receives: Drug: Ipragliflozin (SGLT2 inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change level
Measured: After 52 weeks from the time of treatment initiation
Secondary outcomes (3)
Sugar metabolism and body composition change levels
Change levels of the followings after 12, 24, 36, 52 weeks from the time of treatment initiation:
HbA1c, blood glucose (both at fasting and after eating), glycoalbumin, body weight, BMI, serum lipid (TC、LDL-C、HDL-C、TG), blood pressure (both systolic and diastolic)
Measured: After 12, 24, 36, 52 weeks from the time of the start of treatment
HbA1c achievement rate
The rate of less than HbA1c7.0% achievement after 12, 24, 36, 52 weeks from the time of treatment initiation
Measured: After 12, 24, 36, 52 weeks from the time of treatment initiation
Body composition and visceral fat change levels
Changes of the body composition examined by DEXA (Dual-energy X-ray absorptiometry) method and visceral fat examined by CT scan after 24 and 52 weeks from the time of treatment initiation
Measured: After 24 and 52 weeks from the time of treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startNov 2014
- Primary completion21 Nov 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Osaka Saiseikai Nakatsu Hospital, Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Haruo Nishimura, Principal investigator, Osaka Saiseikai Nakatsu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317484
- Sponsor's protocol ID
- TRIEND1413
- Acronym
- HARUKAS
- Status last verified
- Apr 2018
- First submitted
- 11 Dec 2014
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation for Clinical Efficacy and Safety of Ipragliflozin 50mg and 100mg on Type II Diabetes
- ClinicalTrials.gov ID
- NCT02317484
- Acronym / sponsor ID
- HARUKAS / TRIEND1413
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Osaka Saiseikai Nakatsu Hospital, Astellas Pharma Inc
- Study start
- Nov 2014
- Primary completion
- 21 Nov 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 16 Dec 2014 (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 evaluate clinical efficacy and safety of Sodium Glucose Co-transporter 2 (SGLT2) inhibitor, ipragliflozin, at doses of 50mg and 100mg, for Type II Diabetes under usual care. It is also to investigate and analyze the exploratory influential factor of ipragliflozin treatment on clinical efficacy and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ipragliflozin (SGLT2 inhibitor) | – | Drug: Ipragliflozin (SGLT2 inhibitor) |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic and hospital
Key inclusion criteria (5 listed)
- Diabetes Mellitus, Type 2 patients poorly-controlled by diet and exercise therapies or additional treatment with various diabetic drugs
- Patients with changes within +- 0.5% of HbA1c
- Patients with the variation of 6.5% =< HbA1C =<10%
- Patients with written informed consents
- Patients whose BMI is =>20kg/m2
Key exclusion criteria (12 listed)
- Patients with Diabetes Mellitus, Type 1, other types of diabetes or pregnancy diabetes
- Patients with history of severe ketoacidosis, diabetic coma or profound coma for the last 6 months
- Patients with severe infection, in the perioperative period or severe trauma
- Patients with moderate renal insufficiency (serum creatinine level: male with greater than or equal to 1.5mg/dL、female with greater than or equal to1.3mg/dL)
- Patients with severe hepatic impairment (judged by the attending doctor)
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 |
|---|---|---|
| Ipragliflozin (SGLT2 inhibitor) | Drug | Ipragliflozin (SGLT2 inhibitor) |
Primary outcome
HbA1c change level
Time frame: After 52 weeks from the time of treatment initiation
3 secondary outcomes
Sugar metabolism and body composition change levels
Time frame: After 12, 24, 36, 52 weeks from the time of the start of treatment
HbA1c achievement rate
Time frame: After 12, 24, 36, 52 weeks from the time of treatment initiation
Body composition and visceral fat change levels
Time frame: After 24 and 52 weeks from the time of treatment initiation
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 17 Apr 2018.
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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.
Haruo Nishimura principal investigator
Osaka Saiseikai Nakatsu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 1 site in Japan.
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 12 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 17 Apr 2018. 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 Japan. 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.
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?
HbA1c change level (time frame: After 52 weeks from the time of treatment initiation). 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 17 Apr 2018.