Type 2 Diabetes MellitusNCT02003014

Pioglitazone Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"

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

Completed

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

Trial summary

To investigate the safety and efficacy of long-term treatment with pioglitazone (Actos tablets) in combination with biguanides (for 12 months after the start of pioglitazone tablets treatment) in patients with type 2 diabetes mellitus. Read more about this study

Who is it for?: Any age
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Pioglitazone
Type of treatment: Pill or oral medicine
How many people: 899 participants
Where: No sites listed yet
Study dates: Feb 2009to Jan 2012
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: Type 2 diabetes mellitus

Who may be able to join

Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy
Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment
Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment

Who cannot join

Patients who have received Actos Tablets within the past 3 months.
Patients who started treatment with biguanides and Actos Tablets simultaneously
Patients who discontinued biguanides and switched to Actos Tablets treatment.
Patients who received additional biguanides after the start of Actos Tablets treatment
Patients with contraindications to Actos Tablets treatment

About this study

Official title: Actos Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"

Read the detailed description

This is a special drug use surveillance with an observation period of 12 months designed to investigate the safety and efficacy of pioglitazone (Actos) in the routine clinical setting in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy (planned sample size, 1000).

The usual adult dosage is 15 to 30 mg of pioglitazone administered orally once daily before or after breakfast. Dose adjustment will be made according to gender, age, and symptoms with an upper limit of 45 mg.

Conditions: Type 2 Diabetes Mellitus
Being tested: 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.

PioglitazoneDrug
Also called Actos
Pioglitazone Tablets

Study groups in NCT02003014
Study group	Role	What they receive
Pioglitazone 15 mg to 30 mg		administered orally once daily Receives: Drug: Pioglitazone

What is being measured

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

Number of Participants Reporting One or More Adverse Drug Reactions
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Measured: Baseline up to 12 months
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline up to 12 months

Secondary outcomes (5)

Change From Baseline in Glycosylated Hemoglobin (HbA1c)
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.
Measured: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
Change From Baseline in Fasting Blood Glucose
The change between the fasting blood glucose value collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.
Measured: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
Change From Baseline in Body Weight
Change relative to baseline in participant's weight measured at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12).
Measured: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
Change From Baseline in Immunoreactive Insulin (IRI)
The change in the value of IRI (portion of insulin in blood measured by immunochemical methods for the hormone; presumed to represent the free [unbound] and biologically active fraction of total blood insulin) collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline.
Measured: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
The change between homeostasis model assessment of insulin resistance collected at 3 months, 6 months, 9 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. Homeostasis Model assessment of insulin resistance Measures insulin resistance, calculated by insulin times glucose, divided by a constant (22.5). A higher score indicates higher insulin resistance.
Measured: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)

Timeline

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

Feb 2009Jan 2012

First posted6 Dec 2013 (estimated)
Study startFeb 2009
Primary completionJan 2012
Study completionJan 2012

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: 899 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02003014
Sponsor's protocol ID: 237-017
Other IDs: JapicCTI-132329, JapicCTI-R160828
Status last verified: Sep 2016
First submitted: 1 Dec 2013
Last updated: 10 Nov 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

Official record

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
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
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Actos Tablets Special Drug Use Surveillance "Combined Use of Biguanides / Long-term Treatment"
ClinicalTrials.gov ID: NCT02003014
Acronym / sponsor ID: 237-017
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug Therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 899 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Posted 10 Nov 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
Number of arms: 1

Arm	Type	Receives
Pioglitazone 15 mg to 30 mg	–	Drug: Pioglitazoneadministered orally once daily

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Type 2 diabetes mellitus

Key inclusion criteria (3 listed)

Patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy
Patients with available HbA1c data within the 1 month prior to the start of Actos Tablets treatment
Patients likely to be available for a 12-month observation after the start of Actos Tablets treatment

Key exclusion criteria (5 listed)

Patients who have received Actos Tablets within the past 3 months.
Patients who started treatment with biguanides and Actos Tablets simultaneously
Patients who discontinued biguanides and switched to Actos Tablets treatment.
Patients who received additional biguanides after the start of Actos Tablets treatment
Patients with contraindications to Actos Tablets treatment

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 to 30 mg

Primary outcome

Number of Participants Reporting One or More Adverse Drug Reactions
Time frame: Baseline up to 12 months
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Time frame: Baseline up to 12 months
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

5 secondary outcomes

Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
Change From Baseline in Body Weight
Time frame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
Change From Baseline in Immunoreactive Insulin (IRI)
Time frame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)
Change From Baseline Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, Months 3, 6, 9, 12 and final assessment (up to Month 12)

Results and safety

Results posted to the registry on 10 Nov 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	899	880

Primary outcome: Number of Participants Reporting One or More Adverse Drug Reactions

Time frame: Baseline up to 12 months. Number. Unit: participants

Measure	Pioglitazone n = 880
Value	79

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

Primary outcome: Number of Participants Reporting One or More Serious Adverse Drug Reactions

Time frame: Baseline up to 12 months. Number. Unit: participants

Measure	Pioglitazone n = 880
Value	1

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

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 12 months. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone	12 of 880 (1.4%)	36 of 880 (4.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
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
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

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.

Postmarketing Group Manager study chair

Takeda

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, 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 3 inclusion and 5 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 10 Nov 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 10 Nov 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?

Number of Participants Reporting One or More Adverse Drug Reactions (time frame: Baseline 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 NCT02003014.

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 10 Nov 2016.