Type 2 Diabetes MellitusNCT01990300

Alogliptin/Pioglitazone (Liovel) Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus

An observational study of Type 2 Diabetes Mellitus, run by Takeda at 1 site in Japan.

Completed

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

Trial summary

The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Alogliptin/Pioglitazone
Type of treatment: Pill or oral medicine
How many people: 3,281 participants
Where: 1 siteJapan
Study dates: 28 Nov 2011to 31 Mar 2015
Phase: Observational
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients with type 2 diabetes mellitus who have been examined at a medical institution

Who may be able to join

Patients with type 2 diabetes mellitus

Who cannot join

Patients meeting any of the following criteria will be excluded:
Patients with current cardiac failure or a past history of cardiac failure
Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
Patients with serious hepatic dysfunction
Patients with serious renal dysfunction
Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury
Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone
Pregnant or possibly pregnant women

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Someplace

Other trials in Japan

About this study

Official title: Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With Type 2 Diabetes Mellitus

Read the detailed description

This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.

The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.

Conditions: Type 2 Diabetes Mellitus
Being tested: Alogliptin/Pioglitazone
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.

Alogliptin/PioglitazoneDrug
Also called Liovel、SYR-322-4833
Alogliptin/Pioglitazone combination tablets

Study groups in NCT01990300
Study group	Role	What they receive
Alogliptin/Pioglitazone combination tablets		Alogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. Receives: Drug: Alogliptin/Pioglitazone

What is being measured

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

Number of Participants Who Experience at Least One Adverse Events
Measured: Up to 12 Months
Changes From Baseline in Glycosylated Hemoglobin (HbA1c)
Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).
Measured: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)

Secondary outcomes (1)

Changes From Baseline in Fasting Blood Glucose (FBG)
Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).
Measured: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)

Timeline

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

28 Nov 201131 Mar 2015

First posted21 Nov 2013 (estimated)
Study start28 Nov 2011
Primary completion31 Mar 2015
Study completion31 Mar 2015

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 2 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,281 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01990300
Sponsor's protocol ID: 136-011
Other IDs: JapicCTI-132302
Status last verified: Aug 2023
First submitted: 15 Nov 2013
Last updated: 18 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01990300
Acronym / sponsor ID: 136-011
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 3,281 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 28 Nov 2011 (actual)
Primary completion: 31 Mar 2015 (actual)
Study completion: 31 Mar 2015 (actual)
First posted: 21 Nov 2013 (estimated)
Results: Posted 18 Jan 2019

Clinical summary

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

Detailed description

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.

The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Alogliptin/Pioglitazone combination tablets	–	Drug: Alogliptin/PioglitazoneAlogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients with type 2 diabetes mellitus who have been examined at a medical institution

Key inclusion criteria (1 listed)

Patients with type 2 diabetes mellitus

Key exclusion criteria (8 listed)

Patients meeting any of the following criteria will be excluded:

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: Liovel、SYR-322-4833Alogliptin/Pioglitazone combination tablets	Drug	Alogliptin/Pioglitazone combination tablets

Primary outcome

Number of Participants Who Experience at Least One Adverse Events
Time frame: Up to 12 Months
Changes From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)
Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).

1 secondary outcome

Changes From Baseline in Fasting Blood Glucose (FBG)
Time frame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)

Results and safety

Results posted to the registry on 18 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Alogliptin/Pioglitazone	3,281	3,139

Primary outcome: Number of Participants Who Experience at Least One Adverse Events

Time frame: Up to 12 Months. Count of participants. Unit: Participants

Measure	Alogliptin/Pioglitazone n = 3139
Value	206

Population analysed: The safety analysis set was defined as all participants who were enrolled and completed the study.

Primary outcome: Changes From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months). Mean (Standard Deviation). Unit: Percent HbA1c

Measure	Alogliptin/Pioglitazone n = 2830
Change in HbA1c at Month 1	-0.26 (0.651)
Change in HbA1c at Month 3	-0.58 (0.991)
Change in HbA1c at Month 6	-0.66 (1.081)
Change in HbA1c at Month 12	-0.66 (1.098)
Change in HbA1c at Final Assessment	-0.65 (1.121)

Population analysed: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Month 12. Other adverse events reported at 0.1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alogliptin/Pioglitazone	4 of 3,139 (0.1%)	56 of 3,139 (1.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
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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.

Study Director study director

Takeda

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 Type 2 Diabetes Mellitus, run by Takeda 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 1 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: finished, as of the sponsor's last update on 18 Sep 2023. 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?

Yes. Results are posted in the registry (first posted 18 Jan 2019). 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?

Number of Participants Who Experience at Least One Adverse Events (time frame: Up to 12 Months). The study lists 2 primary outcomes in all. 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 NCT01990300.

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 18 Sep 2023.