Diabetes Mellitus, Type 2Phase 4PEAK-ENCT02763007
An Extension Study of PEAK Trial
A Phase 4 study testing alogliptin+pioglitazone, alogliptin and pioglitazone in people with Diabetes Mellitus, Type 2, run by Kun-Ho Yoon at 1 site in South Korea.
Trial summary
Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- alogliptin+pioglitazone, alogliptin and pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 May 2016to 28 Feb 2019
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed "ALO-IIT-012(PEAK study)", without major protocol deviations.
- Male, or female, 19 years to 75 years.
- Female with childbearing potential who has a negative urine pregnancy test result at study start and willing to continue practice appropriate birth control during the entire duration of study
- Subjects completed PEAK can be included within 30 days after End Of the Study
- Subjects completed PEAK can be included if their treatment is the same as randomized even after 30 days of End Of the Study.
Who cannot join
- eGFR(Epidermal growth factor receptor) < 50mL/min
- AST(aspartate aminotransferase)/ALT(alanine aminotransaminase) >2.5 upper limit of normal
- Pregnant or lactating women
- Subject who the investigator deems inappropriate to participate in this study
- Patients with a history of bladder cancer or patients with active bladder cancer
- Patients with uninvestigated macroscopic hematuria
- Patients with cardiac failure or a history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4)
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this study drug contains lactose
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St Mary's Hospital, The Catholic University of Korea
Seoul, 137-701
About this study
Official title: An Extension Study of Protocol ALO-IIT(PEAK Study) to Examine the Long-term Efficacy and Safety of Metformin + Alogliptin + Pioglitazone Triple Combination Therapy in the Korean Type 2 Diabetes Patients
Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.
Read the detailed description
PEAK trial is now undergoing (Multicenter, randomized, double blind, three-arm parallel group study to evaluate efficacy and safety of Alogliptin and Pioglitazone combination therapy on glucose control in type 2 diabetes subjects who have inadequate control with Metformin monotherapy in Korea, Takeda No. ALO-IIT-012).
Duration of combination treatment is 24 week in the PEAK trial. Long-term efficacy and safety of alogliptin + pioglitazone + metformin combination therapy is not defined in Korea yet.
Thus, extension of the PEAK trial for the longer treatment upto 1 year has been planned.
PEAK trial will be followed by another 28 week open-label treatment of the same drug as initial randomization (total duration of treatment as randomized 52 week), and followed by 2 year of observation.
During observation period, any antidiabetic medication can be added/changed when HbA1c of the subject is off target 7% with clinician's clinical decision.
After 3 years of initial randomization, durability of glucose control will be assessed between 3 treatment group.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- alogliptin+pioglitazone, alogliptin, pioglitazone
- 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.
alogliptin+pioglitazoneDrug
Also called nesina, actos
alogliptin and pioglitazone add on metformin
alogliptinDrug
Also called nesina
nesina add on metformin
pioglitazoneDrug
Also called actos
actos add on metformin
| Study group | Role | What they receive |
|---|---|---|
| alogliptin+pioglitazone | Experimental | A group who treat with alogliptin+pioglitazone: The Combination of Alogliptin 25 mg and pioglitazone 30 mg daily add on metformin for 28 week as extension and followed by 2 years of observation Receives: Drug: alogliptin+pioglitazone |
| alogliptin | Active comparator | A group who treat with alogliptin: Alogliptin 25 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation Receives: Drug: alogliptin |
| pioglitazone | Active comparator | A group who treat with pioglitazone: Pioglitazone 30 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation Receives: Drug: pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving HbA1c <7% after 36 month treatment
The proportion of subjects achieving HbA1c on target < 7.0% after 36 month.
Measured: 36 months after randomization
Secondary outcomes (5)
Proportion of subjects achieving HbA1c <6.5% after 36 month treatment
The proportion of subjects achieving HbA1c on target < 6.5% after 36 month.
Measured: 36 Months after randomization
Proportion of subjects achieving HbA1c <7% after 12 month treatment
The proportion of subjects achieving HbA1c on target < 7.0% after 12 month.
Measured: 12 Months after randomization
Change in glycated hemoglobin(HbA1c) from baseline to 12 month
Change from baseline in HbA1c after 6 month of double blinded treatment followed by 6 month open treatment
Measured: baseline, 12 months
Change in HOMA-IR(homeostasis model assessment of insulin resistance) from baseline to 36 month
Change from baseline in HOMA-IR(homeostasis model assessment of insulin resistance) after 12 month of randomized treatment followed by 24 month observation.
Measured: baseline, 36 months
change of HOMA-beta(homeostasis model assessment of beta cell) from baseline to 36 month
Change from baseline in HOMA-beta(homeostasis model assessment of beta cell) after 12 month of randomized treatment followed by 24 month observation.
Measured: baseline, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start18 May 2016
- Primary completion19 Dec 2018
- Study completion28 Feb 2019
Why it stopped: difficulty in recruiting patients
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kun-Ho Yoon
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor-investigator, Kun-Ho Yoon, The Catholic University of Korea
- Investigators
- Kun-Ho Yoon, MD, PhD, Principal investigator, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763007
- Sponsor's protocol ID
- PEAK-E
- Acronym
- PEAK-E
- Status last verified
- Jun 2019
- First submitted
- 29 Apr 2016
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of Protocol ALO-IIT(PEAK Study) to Examine the Long-term Efficacy and Safety of Metformin + Alogliptin + Pioglitazone Triple Combination Therapy in the Korean Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT02763007
- Acronym / sponsor ID
- PEAK-E / PEAK-E
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in recruiting patients
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Kun-Ho YoonUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 18 May 2016 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 5 May 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.
Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.
Detailed description
PEAK trial is now undergoing (Multicenter, randomized, double blind, three-arm parallel group study to evaluate efficacy and safety of Alogliptin and Pioglitazone combination therapy on glucose control in type 2 diabetes subjects who have inadequate control with Metformin monotherapy in Korea, Takeda No. ALO-IIT-012).
Duration of combination treatment is 24 week in the PEAK trial. Long-term efficacy and safety of alogliptin + pioglitazone + metformin combination therapy is not defined in Korea yet.
Thus, extension of the PEAK trial for the longer treatment upto 1 year has been planned.
PEAK trial will be followed by another 28 week open-label treatment of the same drug as initial randomization (total duration of treatment as randomized 52 week), and followed by 2 year of observation.
During observation period, any antidiabetic medication can be added/changed when HbA1c of the subject is off target 7% with clinician's clinical decision.
After 3 years of initial randomization, durability of glucose control will be assessed between 3 treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| alogliptin+pioglitazone | Experimental | Drug: alogliptin+pioglitazoneA group who treat with alogliptin+pioglitazone: The Combination of Alogliptin 25 mg and pioglitazone 30 mg daily add on metformin for 28 week as extension and followed by 2 years of observation |
| alogliptin | Active comparator | Drug: alogliptinA group who treat with alogliptin: Alogliptin 25 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation |
| pioglitazone | Active comparator | Drug: pioglitazoneA group who treat with pioglitazone: Pioglitazone 30 mg daily add on metformin for for 28 week as extension and followed by 2 years of observation |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completed "ALO-IIT-012(PEAK study)", without major protocol deviations.
- Male, or female, 19 years to 75 years.
- Female with childbearing potential who has a negative urine pregnancy test result at study start and willing to continue practice appropriate birth control during the entire duration of study
- Subjects completed PEAK can be included within 30 days after End Of the Study
- Subjects completed PEAK can be included if their treatment is the same as randomized even after 30 days of End Of the Study.
Key exclusion criteria (8 listed)
- eGFR(Epidermal growth factor receptor) < 50mL/min
- AST(aspartate aminotransferase)/ALT(alanine aminotransaminase) >2.5 upper limit of normal
- Pregnant or lactating women
- Subject who the investigator deems inappropriate to participate in this study
- Patients with a history of bladder cancer or patients with active bladder cancer
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 |
|---|---|---|
| alogliptin+pioglitazoneAlso: nesina, actosalogliptin and pioglitazone add on metformin | Drug | alogliptin+pioglitazone |
| alogliptinAlso: nesinanesina add on metformin | Drug | alogliptin |
| pioglitazoneAlso: actosactos add on metformin | Drug | pioglitazone |
Primary outcome
Proportion of subjects achieving HbA1c <7% after 36 month treatment
Time frame: 36 months after randomization
The proportion of subjects achieving HbA1c on target < 7.0% after 36 month.
5 secondary outcomes
Proportion of subjects achieving HbA1c <6.5% after 36 month treatment
Time frame: 36 Months after randomization
Proportion of subjects achieving HbA1c <7% after 12 month treatment
Time frame: 12 Months after randomization
Change in glycated hemoglobin(HbA1c) from baseline to 12 month
Time frame: baseline, 12 months
Change in HOMA-IR(homeostasis model assessment of insulin resistance) from baseline to 36 month
Time frame: baseline, 36 months
change of HOMA-beta(homeostasis model assessment of beta cell) from baseline to 36 month
Time frame: baseline, 36 months
Results and safety
The study was stopped early (reason given: difficulty in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- 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.
Kun-Ho Yoon, MD, PhD principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
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 alogliptin+pioglitazone, alogliptin and pioglitazone in people with Diabetes Mellitus, Type 2, run by Kun-Ho Yoon 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 8 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 5 Jun 2019. 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 was stopped early (reason given: difficulty in recruiting patients). 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?
Proportion of subjects achieving HbA1c <7% after 36 month treatment (time frame: 36 months after 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 5 Jun 2019.