Type II Diabetes MellitusPhase 4ADDNCT01972724

Efficacy of Pioglitazone in Participants With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy

A Phase 4 study testing Pioglitazone, Metformin and Sulfonylurea in people with Type II Diabetes Mellitus, run by Takeda at 9 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg on glycemic control when used in participants with inadequately controlled type 2 diabetes mellitus treated with stable combinations of metformin and sulfonylurea. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Type II Diabetes Mellitus
What is being tested?: Pioglitazone, Metformin and Sulfonylurea
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 114 participants
Where: 9 sitesSouth Korea
Study dates: 16 Dec 2013to 17 Oct 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants meeting the following criteria will be considered for inclusion in the study:
Institutional Review Board (IRB)-approved written informed consent form (ICF) must be obtained from the participant or legally authorized representative prior to any trial related procedure (including withdrawal of prohibited medication, if applicable).
Participants with a history of clinical diagnosis of established type 2 diabetes mellitus defined by the American Diabetes Association (ADA) criteria 2012.
Male or female between 18 and 80 years of age.
Participants with stable triple oral therapy of metformin + sulfonylurea + pioglitazone (ACTOS) 15 mg or ACTOSMET(Pioglitazone 15mg/Metformin 850mg) and sulfonylurea for at least 12 weeks at the screening visit.
Participants with glycosylated hemoglobin (HbA1c) ≥7.0% at the screening visit.
Participants with C-peptide ≥1.0 ng/mL at the screening visit.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study, up to 30 days after the last dose of the study medication.

Who cannot join

Participants meeting any of the following criteria will be excluded from enrollment:
Participants with type 1 diabetes mellitus or secondary forms of diabetes.
Participants who have been treated with insulin for ≥7 days within 3 months prior to the screening visit.
Participants with a history of bladder cancer or participants with active bladder cancer.
Participants with a history of acute diabetic complications such as diabetic ketoacidosis.
Participants with a history of acute or chronic metabolic acidosis, including diabetic ketoacidosis.

Show all 22Show fewer

Participants with unstable or rapidly progressive diabetic retinopathy, nephropathy (estimated glomerular filtration rate [eGFR] <60mL/min/1.73m2).
Participants with cardiac insufficiency (e.g., a myocardial infarction, a coronary angioplasty or bypass graft, unstable angina, transient ischemic attacks, or a documented cerebrovascular accident within 6 months prior to the screening visit).
Participants with cardiac failure or history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4).
Participants with a serum alanine transaminase (ALT) level ≥2.5 times the upper limit of normal (ULN), active liver disease, or jaundice.
Participants taking concomitant gemfibrozil or other strong cytochrome P450 (CYP)2C8 inhibitors.
Participants with a history of recurrent or severe hypoglycemia.
Participants with a history of any hemoglobinopathy (such as hemolytic anemias or sickle cell disease) that may affect determination of HbA1c.
Participants with uninvestigated microscopic hematuria
Participants with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, since the study drug contains lactose.
Participants with any other condition judged by the Investigator as unsuitable for the study.
Participants who have used any investigational or experimental drugs or devices within 60 days of the screening visit.
Lactating or pregnant female. A positive pregnancy test before the first administration of investigational medicinal product (IMP) or breastfeeding.
Male participants planning to father during clinical trial conduct or within 3 months after the last planned dose of the IMP.
Participants were previously enrolled into the current clinical trial.
The participants participated in the active treatment phase of another clinical trial where a persisting pharmacodynamic effect of the IMP of that clinical trial cannot be excluded.
Participants are considered unable or unwilling to co-operate adequately, i.e., to follow clinical trial procedures after Investigator has adequately instructed (e.g., language difficulties, etc.) or participants are anticipated not to be available for scheduled clinical trial visits/procedures.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

South Korea9 sites

Study site
Chagwon
Study site
Daegu
Study site
Daejeon
Study site
Gwangju
Study site
Gyeonggi-do
Study site
Jeonju
Study site
Seoul
Study site
Ulsan
Study site
Wŏnju

Other trials in South Korea

About this study

Official title: A 24-Week, Open Label, Phase IV Trial to Evaluate the Efficacy of Pioglitazone 30 mg in Patients With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy of Metformin, Sulfonylurea, and Pioglitazone 15 Mg (ADD Trial)

Read the detailed description

The drug being tested in this study is called pioglitazone. Pioglitazone is being tested to treat glycemic control in adults with inadequately controlled type 2 diabetes mellitus. This study will look at glycemic control in people who take triple oral therapy of metformin, sulfonylurea, and pioglitazone 15 mg.

The study will enroll approximately 114 patients. All participants will be asked to take one pioglitazone tablet at the same time each day throughout the study as well as continuing their previous dose of metformin and sulfonylurea.

This multi-center trial will be conducted in Korea. The overall time to participate in this study is up to 25 weeks. Participants will make 4 visits to the hospital or endocrinologist's office, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment.

Conditions: Type II Diabetes Mellitus
Being tested: Pioglitazone, Metformin, Sulfonylurea
Keywords: Drug therapy
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.

PioglitazoneDrug
Also called ACTOS
Pioglitazone tablets
MetforminDrug
Metformin as prescribed in clinical practice
SulfonylureaDrug
Sulfonylurea as prescribed in clinical practice

Study groups in NCT01972724
Study group	Role	What they receive
Pioglitazone 15 mg (Double-Blind)	Experimental	Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks. Receives: Drug: Pioglitazone; Drug: Metformin; Drug: Sulfonylurea
Pioglitazone 30 mg (Double-Blind)	Experimental	Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks. Receives: Drug: Pioglitazone; Drug: Metformin; Drug: Sulfonylurea
Pioglitazone 30 mg (Open-Label)	Experimental	Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks. Receives: Drug: Pioglitazone; Drug: Metformin; Drug: Sulfonylurea

What is being measured

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

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
The change from baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 24. A negative change from baseline indicates improvement.
Measured: Baseline and Week 24

Secondary outcomes (1)

Change From Baseline in Fasting Plasma Glucose at Week 24
The change between the value of fasting serum glucose collected at Week 24 and fasting serum glucose collected at baseline. A negative change from baseline indicates improvement.
Measured: Baseline and Week 24

Timeline

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

16 Dec 201317 Oct 2016

First posted30 Oct 2013 (estimated)
Study start16 Dec 2013
Primary completion17 Oct 2016
Study completion17 Oct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type II Diabetes MellitusStudies of the same condition, open and under way.
More trials run by TakedaThe 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: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 114 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01972724
Sponsor's protocol ID: PG-9999-301-KR
Other IDs: U1111-1145-8222
Acronym: ADD
Status last verified: Aug 2018
First submitted: 24 Oct 2013
Last updated: 12 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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?

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All Type II Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 24-Week, Open Label, Phase IV Trial to Evaluate the Efficacy of Pioglitazone 30 mg in Patients With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy of Metformin, Sulfonylurea, and Pioglitazone 15 Mg (ADD Trial)
ClinicalTrials.gov ID: NCT01972724
Acronym / sponsor ID: ADD / PG-9999-301-KR
Conditions: Type II Diabetes Mellitus
Keywords: Drug therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 114 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 16 Dec 2013 (actual)
Primary completion: 17 Oct 2016 (actual)
Study completion: 17 Oct 2016 (actual)
First posted: 30 Oct 2013 (estimated)
Results: Posted 24 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Pioglitazone 15 mg (Double-Blind)	Experimental	Drug: Pioglitazone, Drug: Metformin, Drug: SulfonylureaPioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
Pioglitazone 30 mg (Double-Blind)	Experimental	Drug: Pioglitazone, Drug: Metformin, Drug: SulfonylureaPioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
Pioglitazone 30 mg (Open-Label)	Experimental	Drug: Pioglitazone, Drug: Metformin, Drug: SulfonylureaPioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participants meeting the following criteria will be considered for inclusion in the study:
Institutional Review Board (IRB)-approved written informed consent form (ICF) must be obtained from the participant or legally authorized representative prior to any trial related procedure (including withdrawal of prohibited medication, if applicable).
Participants with a history of clinical diagnosis of established type 2 diabetes mellitus defined by the American Diabetes Association (ADA) criteria 2012.
Male or female between 18 and 80 years of age.
Participants with stable triple oral therapy of metformin + sulfonylurea + pioglitazone (ACTOS) 15 mg or ACTOSMET(Pioglitazone 15mg/Metformin 850mg) and sulfonylurea for at least 12 weeks at the screening visit.

Key exclusion criteria (22 listed)

Participants with type 1 diabetes mellitus or secondary forms of diabetes.
Participants who have been treated with insulin for ≥7 days within 3 months prior to the screening visit.
Participants with a history of bladder cancer or participants with active bladder cancer.
Participants with a history of acute diabetic complications such as diabetic ketoacidosis.
Participants with a history of acute or chronic metabolic acidosis, including 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
PioglitazoneAlso: ACTOSPioglitazone tablets	Drug	Pioglitazone 15 mg (Double-Blind), Pioglitazone 30 mg (Double-Blind), Pioglitazone 30 mg (Open-Label)
MetforminMetformin as prescribed in clinical practice	Drug	Pioglitazone 15 mg (Double-Blind), Pioglitazone 30 mg (Double-Blind), Pioglitazone 30 mg (Open-Label)
SulfonylureaSulfonylurea as prescribed in clinical practice	Drug	Pioglitazone 15 mg (Double-Blind), Pioglitazone 30 mg (Double-Blind), Pioglitazone 30 mg (Open-Label)

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Time frame: Baseline and Week 24
The change from baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 24. A negative change from baseline indicates improvement.

1 secondary outcome

Change From Baseline in Fasting Plasma Glucose at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 24 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pioglitazone 15 mg (Double-Blind)	19	10
Pioglitazone 30 mg (Double-Blind)	18	9
Pioglitazone 30 mg (Open-Label)	0	0

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

Time frame: Baseline and Week 24. Mean (Standard Deviation). Unit: percentage of glycosylated hemoglobin

Measure	Pioglitazone 15 mg (Double-Blind) n = 17	Pioglitazone 30 mg (Double-Blind) n = 17	Pioglitazone 30 mg (Open-Label) n = 76
Value	-0.0003 (0.00725)	-0.0030 (0.00894)	-0.0275 (0.21126)

Population analysed: Intent-to-treat population was defined as all participants who took at least 1 dose of the study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone 15 mg (Double-Blind)	1 of 17 (5.9%)	3 of 17 (17.6%)	Not reported
Pioglitazone 30 mg (Double-Blind)	0 of 17 (0%)	7 of 17 (41.2%)	Not reported
Pioglitazone 30 mg (Open-Label)	3 of 77 (3.9%)	0 of 77 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
ACTOS® Package InsertLink provided by the sponsor.

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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 Director study director

Takeda

9 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 Pioglitazone, Metformin and Sulfonylurea in people with Type II Diabetes Mellitus, run by Takeda at 9 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 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 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Yes. Results are posted in the registry (first posted 24 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline and Week 24). 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 NCT01972724.

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 12 Sep 2018.