Type 2 Diabetes MellitusPhase 2/3NCT01318122

Long-term Safety Study of Alogliptin Used in Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan

A Phase 2/3 study testing Alogliptin and pioglitazone in people with 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

The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and Thiazolidine administered once daily (QD) for 40 consecutive weeks in participants who completed a phase 2/3 Thiazolidine add on study. Read more about this study

Who is it for?: Ages 33 to 88 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Alogliptin and pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 336 participants
Where: No sites listed yet
Study dates: May 2008to Aug 2009
Phase: Phase 2/3
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 33 to 88 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Had completed the core phase 2/3 thiazolidine add on study.
The subject was capable of understanding and complying with protocol requirements.
Signed a written, informed consent form prior to the initiation of any study procedure.

Who cannot join

With clinical manifestation of hepatic impairment (e.g., an AST or ALT value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 thiazolidine add on study).
With clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of the core phase 2/3 thiazolidine add on study).
With a history or symptoms of cardiac failure.

About this study

Official title: A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR-322 When Used in Combination With Thiazolidine in Subjects With Type 2 Diabetes in Japan

Read the detailed description

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study were enrolled from a core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070).

Conditions: Type 2 Diabetes Mellitus
Being tested: Alogliptin and pioglitazone
Keywords: Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Alogliptin and pioglitazoneDrug
Also called SYR-322, Actos
Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
Alogliptin and pioglitazoneDrug
Also called SYR-322, Actos
Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.

Study groups in NCT01318122
Study group	Role	What they receive
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD	Active comparator	Not described Receives: Drug: Alogliptin and pioglitazone
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD	Active comparator	Not described Receives: Drug: Alogliptin and pioglitazone

What is being measured

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

Number of Participants With Adverse Events.
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
Measured: 52 Weeks.

Secondary outcomes (30)

Change From Baseline in Glycosylated Hemoglobin (Week 8).
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 week 8 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 8.
Change From Baseline in Glycosylated Hemoglobin (Week 12).
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 week 12 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
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 week 16 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
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 week 20 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 20.
Change From Baseline in Glycosylated Hemoglobin (Week 24).
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 week 24 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 24.
Change From Baseline in Glycosylated Hemoglobin (Week 28).
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 week 28 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 28.
Change From Baseline in Glycosylated Hemoglobin (Week 32).
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 week 32 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 32.
Change From Baseline in Glycosylated Hemoglobin (Week 36).
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 week 36 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 36.
Change From Baseline in Glycosylated Hemoglobin (Week 40).
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 week 40 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 40.
Change From Baseline in Glycosylated Hemoglobin (Week 44).
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 week 44 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 44.
Change From Baseline in Glycosylated Hemoglobin (Week 48).
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 week 48 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 48.
Change From Baseline in Glycosylated Hemoglobin (Week 52).
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 week 52 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Week 52.
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
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 week 52 or final visit and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Final Visit (up to Week 52).
Change From Baseline in Fasting Blood Glucose (Week 8).
The change between the value of fasting blood glucose collected at week 8 and baseline.
Measured: Baseline and Week 8.
Change From Baseline in Fasting Blood Glucose (Week 12).
The change between the value of fasting blood glucose collected at week 12 and baseline.
Measured: Baseline and Week 12.
Change From Baseline in Fasting Blood Glucose (Week 16).
The change between the value of fasting blood glucose collected at week 6 and baseline.
Measured: Baseline and Week 16.
Change From Baseline in Fasting Blood Glucose (Week 20).
The change between the value of fasting blood glucose collected at week 20 and baseline.
Measured: Baseline and Week 20.
Change From Baseline in Fasting Blood Glucose (Week 24).
The change between the value of fasting blood glucose collected at week 24 and baseline.
Measured: Baseline and Week 24.
Change From Baseline in Fasting Blood Glucose (Week 28).
The change between the value of fasting blood glucose collected at week 28 and baseline.
Measured: Baseline and Week 28.
Change From Baseline in Fasting Blood Glucose (Week 32).
The change between the value of fasting blood glucose collected at week 32 and baseline.
Measured: Baseline and Week 32.
Change From Baseline in Fasting Blood Glucose (Week 36).
The change between the value of fasting blood glucose collected at week 36 and baseline.
Measured: Baseline and Week 36.
Change From Baseline in Fasting Blood Glucose (Week 40).
The change between the value of fasting blood glucose collected at week 40 and baseline.
Measured: Baseline and Week 40.
Change From Baseline in Fasting Blood Glucose (Week 44).
The change between the value of fasting blood glucose collected at week 44 and baseline.
Measured: Baseline and Week 44.
Change From Baseline in Fasting Blood Glucose (Week 48).
The change between the value of fasting blood glucose collected at week 48 and baseline.
Measured: Baseline and Week 48.
Change From Baseline in Fasting Blood Glucose (Week 52).
The change between the value of fasting blood glucose collected at week 52 and baseline.
Measured: Baseline and Week 52.
Change From Baseline in Fasting Blood Glucose (Final Visit).
The change between the value of fasting blood glucose collected at week 52 or final visit and baseline.
Measured: Baseline and Final Visit (up to Week 52).
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
The change between the value of blood glucose measured by the meal tolerance test collected at week 12 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Measured: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
The change between the value of blood glucose measured by the meal tolerance test collected at week 24 and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Measured: Baseline and Week 24.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or final visit and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Measured: Baseline and Week 52.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
The change between the value of blood glucose measured by the meal tolerance test collected at week 52 or end of study and blood glucose measured by the meal tolerance test collected at baseline. Meal tolerance test measures blood glucose through blood samples drawn before a meal and at 2 hours after the start of the meal.
Measured: Baseline and Final Visit (up to Week 52).

Timeline

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

May 2008Aug 2009

First posted18 Mar 2011 (estimated)
Study startMay 2008
Primary completionAug 2009
Study completionAug 2009

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: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 336 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01318122
Sponsor's protocol ID: SYR-322/OCT-004
Other IDs: U1111-1119-6207
Status last verified: Feb 2012
First submitted: 16 Mar 2011
Last updated: 3 Feb 2012
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

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-Term, Open-Label Extension Study to Investigate the Long-Term Safety of SYR-322 When Used in Combination With Thiazolidine in Subjects With Type 2 Diabetes in Japan
ClinicalTrials.gov ID: NCT01318122
Acronym / sponsor ID: SYR-322/OCT-004
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes Mellitus - Type 2, Diabetes Mellitus, Drug Therapy
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 336 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 18 Mar 2011 (estimated)
Results: Posted 2 Sep 2011

Clinical summary

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

Detailed description

Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus.

To evaluate the long-term safety and efficacy of alogliptin, participants in the present study were enrolled from a core phase 2/3 thiazolidine add on study (SYR-322/CCT-004; NCT01318070).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD	Active comparator	Drug: Alogliptin and pioglitazone
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD	Active comparator	Drug: Alogliptin and pioglitazone

Who may qualify

Ages: 33 to 88 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Had completed the core phase 2/3 thiazolidine add on study.
The subject was capable of understanding and complying with protocol requirements.
Signed a written, informed consent form prior to the initiation of any study procedure.

Key exclusion criteria (3 listed)

With clinical manifestation of hepatic impairment (e.g., an AST or ALT value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 thiazolidine add on study).
With clinical manifestation of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of the core phase 2/3 thiazolidine add on study).
With a history or symptoms of cardiac failure.

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 and pioglitazoneAlso: SYR-322, ActosAlogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.	Drug	Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD
Alogliptin and pioglitazoneAlso: SYR-322, ActosAlogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.	Drug	Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD

Primary outcome

Number of Participants With Adverse Events.
Time frame: 52 Weeks.
Treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.

30 secondary outcomes

Change From Baseline in Glycosylated Hemoglobin (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Glycosylated Hemoglobin (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Glycosylated Hemoglobin (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Glycosylated Hemoglobin (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Glycosylated Hemoglobin (Week 24).
Time frame: Baseline and Week 24.
Change From Baseline in Glycosylated Hemoglobin (Week 28).
Time frame: Baseline and Week 28.
Change From Baseline in Glycosylated Hemoglobin (Week 32).
Time frame: Baseline and Week 32.
Change From Baseline in Glycosylated Hemoglobin (Week 36).
Time frame: Baseline and Week 36.
Change From Baseline in Glycosylated Hemoglobin (Week 40).
Time frame: Baseline and Week 40.
Change From Baseline in Glycosylated Hemoglobin (Week 44).
Time frame: Baseline and Week 44.
Change From Baseline in Glycosylated Hemoglobin (Week 48).
Time frame: Baseline and Week 48.
Change From Baseline in Glycosylated Hemoglobin (Week 52).
Time frame: Baseline and Week 52.
Change From Baseline in Glycosylated Hemoglobin (Final Visit).
Time frame: Baseline and Final Visit (up to Week 52).
Change From Baseline in Fasting Blood Glucose (Week 8).
Time frame: Baseline and Week 8.
Change From Baseline in Fasting Blood Glucose (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Fasting Blood Glucose (Week 16).
Time frame: Baseline and Week 16.
Change From Baseline in Fasting Blood Glucose (Week 20).
Time frame: Baseline and Week 20.
Change From Baseline in Fasting Blood Glucose (Week 24).
Time frame: Baseline and Week 24.
Change From Baseline in Fasting Blood Glucose (Week 28).
Time frame: Baseline and Week 28.
Change From Baseline in Fasting Blood Glucose (Week 32).
Time frame: Baseline and Week 32.
Change From Baseline in Fasting Blood Glucose (Week 36).
Time frame: Baseline and Week 36.
Change From Baseline in Fasting Blood Glucose (Week 40).
Time frame: Baseline and Week 40.
Change From Baseline in Fasting Blood Glucose (Week 44).
Time frame: Baseline and Week 44.
Change From Baseline in Fasting Blood Glucose (Week 48).
Time frame: Baseline and Week 48.
Change From Baseline in Fasting Blood Glucose (Week 52).
Time frame: Baseline and Week 52.
Change From Baseline in Fasting Blood Glucose (Final Visit).
Time frame: Baseline and Final Visit (up to Week 52).
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 12).
Time frame: Baseline and Week 12.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 24).
Time frame: Baseline and Week 24.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Week 52).
Time frame: Baseline and Week 52.
Change From Baseline in Blood Glucose Measured by the Meal Tolerance Test (Final Visit).
Time frame: Baseline and Final Visit (up to Week 52).

Results and safety

Results posted to the registry on 2 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group	106	105
CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group	110	110
Pioglitazone Monotherapy Group* → 12.5 mg Combination Group	57	55
Pioglitazone Monotherapy Group* → 25 mg Combination Group	53	52

Primary outcome: Number of Participants With Adverse Events.

Time frame: 52 Weeks.. Number. Unit: participants

Measure	Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD n = 166	Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD n = 165
Number of Participants with Serious Adverse Event	14	11
Number of Participants with Other Adverse Event	143	146

Population analysed: Full Analysis Set was defined as the population of participants randomized in the core phase 2/3 thiazolidine add on study (SYR-322/CCT-004 study; NCT01318070) and received at least 1 dose of the investigational products (SYR-322DB in combination with pioglitazone) for the treatment period.

30 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through receiving the last dose of study drug.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD	14 of 166 (8.4%)	143 of 166 (86.1%)	Not reported
Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD	11 of 165 (6.7%)	146 of 165 (88.5%)	Not reported

Limitations and caveats (from the sponsor): 331 participants were randomized in the core phase 2/3 thiazolidine (CCT-004) study and included in the Full Analysis Set in this study. 5 participants from CCT-004 study did not enter this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Professor, Department of Medicine study director

Department of Medicine, Kawasaki Medical School

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Alogliptin and pioglitazone in people with 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 3 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 3 Feb 2012. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 2 Sep 2011). 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 With Adverse Events. (time frame: 52 Weeks.). 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 NCT01318122.

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 3 Feb 2012.