DiabetesPhase 4NCT02823808
Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function
A Phase 4 study testing NESINA ACT TAB. 25/15mg and AMARYL-M TAB. 2/500mg in people with Diabetes, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol. All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks. Read more about this study
- Who is it for?
- Ages 26 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- NESINA ACT TAB. 25/15mg and AMARYL-M TAB. 2/500mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2017to Dec 2021
- 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 26 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 Diabetes Mellitus patients
- Patient who had been diagnosed within the previous 12 months with HbA1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy
Who cannot join
- The use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months
- Previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks
- The use of insulin within the 3 months prior to screening
- Others
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyunghee University Medical Center
Seoul
Sang Youl Rhee
About this study
Official title: Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function After Early Intensive Diabetes Treatment
All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol.
- All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks.
- Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.
- Conditions
- Diabetes
- Being tested
- NESINA ACT TAB. 25/15mg, AMARYL-M TAB. 2/500mg
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NESINA ACT TAB. 25/15mgDrug
Alogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
AMARYL-M TAB. 2/500mgDrug
Glymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
| Study group | Role | What they receive |
|---|---|---|
| ALO+PIO | Experimental | Group who takes Alogliptin 25mg+Pioglitazone 15mg, once daily. Receives: Drug: NESINA ACT TAB. 25/15mg |
| GMPD+MET | Active comparator | Group who takes Glimepiride 2mg+Metformin 500mg, once daily. Receives: Drug: AMARYL-M TAB. 2/500mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative treatment failure (HbA1c≥7.0%) rate for glycemic control
Measured: 104 weeks from randomization
Secondary outcomes (7)
Change in HbA1c
Measured: 104 weeks from randomization
Change in Fasting Blood Sugar
Measured: 104 weeks from randomization
Change in Glycoalbumin
Measured: 104 weeks from randomization
Change in insulin sensitivity (HOMA2%S)
Measured: 104 weeks from randomization
Change in insulin sensitivity (HOMA2%B)
Measured: 104 weeks from randomization
Change in proinsulin
Measured: 104 weeks from randomization
Change in glucagon
Measured: 104 weeks from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startJul 2017 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, Kyung Hee University Hospital at Gangdong, Bucheon St. Mary's Hospital, Korea University Guro Hospital, Ajou University School of Medicine, Inha University Hospital, Kangbuk Samsung Hospital, Seoul Medical Center
- Responsible party
- Principal investigator, Jeong-taek Woo, Kyunghee University Medical Center
- Investigators
- Jeong-taek Woo, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823808
- Sponsor's protocol ID
- KNDP_IIT_2016_01
- Status last verified
- Jul 2017
- First submitted
- 1 Jul 2016
- Last updated
- 25 Jul 2017
- 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 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function After Early Intensive Diabetes Treatment
- ClinicalTrials.gov ID
- NCT02823808
- Acronym / sponsor ID
- KNDP_IIT_2016_01
- Conditions
- Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Takeda, Kyung Hee University Hospital at Gangdong, Bucheon St. Mary's Hospital, Korea University Guro Hospital, Ajou University School of Medicine, Inha University Hospital, Kangbuk Samsung Hospital, Seoul Medical Center
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Jul 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.
All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol.
- All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks.
- Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALO+PIO | Experimental | Drug: NESINA ACT TAB. 25/15mgGroup who takes Alogliptin 25mg+Pioglitazone 15mg, once daily. |
| GMPD+MET | Active comparator | Drug: AMARYL-M TAB. 2/500mgGroup who takes Glimepiride 2mg+Metformin 500mg, once daily. |
Who may qualify
- Ages
- 26 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 Diabetes Mellitus patients
- Patient who had been diagnosed within the previous 12 months with HbA1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy
Key exclusion criteria (4 listed)
- The use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months
- Previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks
- The use of insulin within the 3 months prior to screening
- Others
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 |
|---|---|---|
| NESINA ACT TAB. 25/15mgAlogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week. | Drug | ALO+PIO |
| AMARYL-M TAB. 2/500mgGlymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week. | Drug | GMPD+MET |
Primary outcome
Cumulative treatment failure (HbA1c≥7.0%) rate for glycemic control
Time frame: 104 weeks from randomization
7 secondary outcomes
Change in HbA1c
Time frame: 104 weeks from randomization
Change in Fasting Blood Sugar
Time frame: 104 weeks from randomization
Change in Glycoalbumin
Time frame: 104 weeks from randomization
Change in insulin sensitivity (HOMA2%S)
Time frame: 104 weeks from randomization
Change in insulin sensitivity (HOMA2%B)
Time frame: 104 weeks from randomization
Change in proinsulin
Time frame: 104 weeks from randomization
Change in glucagon
Time frame: 104 weeks from randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- 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.
Jeong-taek Woo principal investigator
Kyung Hee University Hospital
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 NESINA ACT TAB. 25/15mg and AMARYL-M TAB. 2/500mg in people with Diabetes, run by Kyunghee University 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 2 inclusion and 4 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 25 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeong-taek Woo (822-958-8200, jtwoomd@khmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative treatment failure (HbA1c≥7.0%) rate for glycemic control (time frame: 104 weeks from randomization). 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 25 Jul 2017.