An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications

An observational study of Diabetes Mellitus, Type 2, run by Takeda.

Completed

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

Trial summary

The purpose of this study was to investigate the mortality and macrovascular morbidity as well as the incidence of malignancies over time, in high-risk diabetic participants who previously received long-term treatment with either pioglitazone or placebo in combination with their usual medication for glycaemic… Read more about this study

Who is it for?: Ages 36 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
How many people: 3,599 participants
Where: No sites listed yet
Study dates: Nov 2004to Nov 2011
How long will I take part?: 10 Years
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 36 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: High-risk T2DM participants previously treated with pioglitazone and placebo in PROactive study (NCT00174993) were included in this study.

Who may be able to join

Completion of the final visit of the PROactive Study (NCT00174993).
Willingness and ability to give written informed consent for the observational study.

Who cannot join

There were no exclusion criteria.

About this study

Official title: An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications.

Read the detailed description

This was a European,multicenter,observational study of participants who were previously treated with pioglitazone or placebo in addition to their existing anti diabetic medication. This 10-year observational study was conducted as a follow-up of PROactive study (NCT00174993) to investigate the CV and macrovascular effects observed with pioglitazone over time during PROactive.In this study,high risk T2DM patients previously enrolled in PROactive were analyzed for long-term incidence,nature, and pattern of all malignancies in pioglitazone and placebo-treated groups.This study enrolled 3599 participants.No treatment was prescribed by this protocol and participants will be managed in accordance with normal medical practice.The planned total duration of the study was 10 years,with data being analyzed and reported every 2 years.Participants were assessed at nominal visits every 6 months and every effort was made to obtain as much of the required information as possible.

Conditions: Diabetes Mellitus, Type 2
Being tested: No Intervention
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.

No InterventionOther
Participants who previously received Pioglitazone in the PROactive study (NCT00174993).
No InterventionOther
Participants who previously received pioglitazone-matching placebo in the PROactive study (NCT00174993).

Study groups in NCT02678676
Study group	Role	What they receive
Pioglitazone		Participants who previously received pioglitazone in the PROactive study (NCT00174993). Receives: Other: No Intervention
Placebo		Participants who previously received Pioglitazone-matching placebo in the PROactive study (NCT00174993). Receives: Other: No Intervention

What is being measured

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

Percentage of Participants With First Occurrence of Macro-vascular Event or Death
The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.
Measured: Up to Year 10

Secondary outcomes (1)

Incidences With Malignancies
Percentage of participants with incidences of at least 1 malignancy was reported. All malignancies included adrenal, biliary, bladder, brain, breast, cervix, colon/rectal, gastric, hematological, hepatic, lung, mesothelioma, metastases, oesophageal, oropharyngeal, ovarian/uterine, pancreas, prostate, renal, skin and others.
Measured: Up to Year 10

Timeline

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

Nov 2004Nov 2011

First posted10 Feb 2016 (estimated)
Study startNov 2004
Primary completionNov 2011
Study completionNov 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies 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: 3,599 participants (actual)
Target duration: 10 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT02678676
Sponsor's protocol ID: AD-4833/EC445
Status last verified: May 2016
First submitted: 7 Feb 2016
Last updated: 7 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Erdmann E, Harding S, Lam H, Perez A. Ten-year observational follow-up of PROactive: a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes. Diabetes Obes Metab. 2016 Mar;18(3):266-73. doi: 10.1111/dom.12608. Epub 2016 Jan 8.
PubMed 26592506

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?

Official record

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study of Patient Cohorts Who Previously Received Long-term Treatment With Pioglitazone or Placebo in Addition to Existing Antidiabetic Medications.
ClinicalTrials.gov ID: NCT02678676
Acronym / sponsor ID: AD-4833/EC445
Conditions: Diabetes Mellitus, Type 2
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 3,599 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Nov 2004
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 10 Feb 2016 (estimated)
Results: Posted 7 Jul 2016

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

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 10 Years
Number of arms: 2

Arm	Type	Receives
Pioglitazone	–	Other: No InterventionParticipants who previously received pioglitazone in the PROactive study (NCT00174993).
Placebo	–	Other: No InterventionParticipants who previously received Pioglitazone-matching placebo in the PROactive study (NCT00174993).

Who may qualify

Ages: 36 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: High-risk T2DM participants previously treated with pioglitazone and placebo in PROactive study (NCT00174993) were included in this study.

Key inclusion criteria (2 listed)

Completion of the final visit of the PROactive Study (NCT00174993).
Willingness and ability to give written informed consent for the observational study.

Key exclusion criteria (1 listed)

There were no exclusion criteria.

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
No InterventionParticipants who previously received Pioglitazone in the PROactive study (NCT00174993).	Other	Pioglitazone
No InterventionParticipants who previously received pioglitazone-matching placebo in the PROactive study (NCT00174993).	Other	Placebo

Primary outcome

Percentage of Participants With First Occurrence of Macro-vascular Event or Death
Time frame: Up to Year 10
The composite macro-vascular event or death included all-cause mortality, non-fatal myocardial infarction, cardiac intervention, stroke, major leg amputation (above the ankle), bypass surgery or revascularization in the leg. The percentage of participants in the observational study population having first occurrence of macro-vascular event or death during the 10-year observational study period was analyzed. The data were analyzed using the Cox regression with respect to time to the first occurrence of macro-vascular event or death.

1 secondary outcome

Incidences With Malignancies
Time frame: Up to Year 10

Results and safety

Results posted to the registry on 7 Jul 2016, 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	1,820	932
Placebo	1,779	907

Primary outcome: Percentage of Participants With First Occurrence of Macro-vascular Event or Death

Time frame: Up to Year 10. Number. Unit: percentage of participants

Measure	Pioglitazone n = 1820	Placebo n = 1779
Value	58 (NA)	60.3 (NA)

Pioglitazone vs Placebo: Hazard Ratio (HR): 0.96 (95% CI 0.88 to 1.04), p = 0.3444, Regression, Cox

Population analysed: The observational study population consisted of participants who enrolled in this study after completing the final visit of PROactive study (NCT00174993).

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone	0 of 0	0 of 0	Not reported
Placebo	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26592506Erdmann E, Harding S, Lam H, Perez A. Ten-year observational follow-up of PROactive: a randomized cardiovascular outcomes trial evaluating pioglitazone in type 2 diabetes. Diabetes Obes Metab. 2016 Mar;18(3):266-73. doi: 10.1111/dom.12608. Epub 2016 Jan 8.

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Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
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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

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Takeda.

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 1 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 7 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

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 7 Jul 2016). 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?

Percentage of Participants With First Occurrence of Macro-vascular Event or Death (time frame: Up to Year 10). 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 NCT02678676, which also lists 1 linked publication.

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 7 Jul 2016.