Safety and Efficacy Study of Alogliptin on Glycemic Control in Subjects With Type 2 Diabetes.

A Phase 2 study testing Alogliptin in people with 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 is to determine the safety and efficacy of alogliptin, once daily (QD), compared to diet and exercise, sulfonylurea, metformin and a combination of sulfonylurea and metformin for treating subjects with type 2 diabetes. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Alogliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 265 participants
Where: No sites listed yet
Study dates: Mar 2005to Oct 2005
Phase: Phase 2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has type 2 diabetes mellitus and were either receiving no current treatment or currently treated with a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin but experiencing inadequate glycemic control. Subjects qualified as receiving no current treatment if 1 of the following conditions applied:
Subject was newly diagnosed (ie, had not received any treatment).
Subject was treated with diet and exercise alone for the 3 months prior to Screening
Subject had received <7 continuous days of any antidiabetic therapy within the 3 months prior to Screening.
Subject had a diagnosis of type 2 diabetes mellitus based on current American Diabetes Association criteria: fasting plasma glucose ≥126 mg/dL, oral glucose tolerance test at 2 hours after administration of the glucose load must have been ≥200 mg/dL, or symptoms of diabetes plus casual plasma glucose ≥200 mg/dL.
Body mass index ≥23 kg/m2 and ≤40 kg/m2.

Show all 22Show fewer

Fasting C-peptide concentration ≥0.8 ng/mL.
Glycosylated hemoglobin concentration between 6.8% and 11.0%.
Fasting plasma glucose >126 mg/dL at Screening.
No treatment within the 3 months prior to Screening with any other agents known to have effects on glucose (other than as described above, a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin in subjects on antidiabetics), including but not limited to the following:
Other antidiabetic agents
Investigational antidiabetic agents
Niacin
Regular use of systemic glucocorticoids.
No treatment within the 3 months prior to Screening with weight-loss drugs
If taking other non-excluded medications, must have been on a stable dose of medication for at least 4 weeks.
Diastolic blood pressure ≤110 mm Hg and a systolic pressure of ≤180 mm Hg.
Female subjects could neither be pregnant (confirmed by laboratory testing) nor lactating, and if of childbearing potential must have been practicing adequate contraception.
Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
No major illness or debility that in the investigator's opinion prohibited the subject from completing the study.
Hemoglobin ≥12 g/dL for males and ≥10 g/dL for females.
Hepatic transaminase ≤2 x upper limit of normal.

Who cannot join

History of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 1 year prior to Screening.
History of proteinuria >1000 mg/day on a 12- or 24-hour urine collection OR a urine albumin/creatinine ratio >1000 μg/mg at Screening. If elevated, the subject was to be rescreened within 1 week.
Serum creatinine ≥2.0 mg/dL.
History of proliferative diabetic retinopathy OR any history of laser-treated retinopathy.
History of treated peripheral or autonomic neuropathy.
History of systolic dysfunction congestive heart failure.

Show all 15Show fewer

History of myocardial infarction within 1 year prior to Screening.
History of ulcerative colitis or Crohn's disease.
History of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
History of a psychiatric disorder that would affect the subject's ability to participate in the study.
History of anaphylactic reaction(s) to any drug.
History of angioedema.
History of alcohol or substance abuse within the last 2 years.
History of any surgery that could potentially affect the absorption of the study drug.
Receipt of any investigational drug within the preceding 30 days or a history of receipt of an investigational antidiabetic drug within the preceding 90 days.

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparison Study to Determine the Efficacy and Safety of SYR110322 in Patients With Type 2 Diabetes, Who Are Either Receiving No Current Treatment or Currently Treated With Diet and Exercise, Sulfonylurea, Metformin or a Combination of Sulfonylurea and Metformin

Read the detailed description

Of the approximately 19 million people in the United States who have been diagnosed with diabetes mellitus, 90% to 95% have type 2 diabetes mellitus. The prevalence of type 2 diabetes mellitus varies among racial and ethnic populations and has been shown to increase with age, obesity, family history, history of gestational diabetes, and physical inactivity. Over the next decade, a disproportionate increase in the elderly population will result in a marked increase in diabetic patients, placing an ever-increasing burden on families and the health care system.

In response to this problem, Takeda Global Research \& Development Center, Inc. is developing SYR-322 (alogliptin), a selective, orally available inhibitor of the enzyme dipeptidyl peptidase IV. Dipeptidyl peptidase IV is thought to be primarily responsible for the in vivo degradation of 2 peptide hormones released in response to nutrient ingestion, namely glucagon-like peptide-1 and glucose-dependent insulinotropic peptide.

Individuals who want to participate in this study will be required to provide written informed consent. Study participation is anticipated to be about 14 Weeks. Multiple procedures will occur at each visit which may include blood collection, urine collection, vital signs including sitting and standing blood pressure and pulse, body height and weight, physical examinations and electrocardiograms.

Conditions: Diabetes Mellitus
Being tested: Alogliptin, Placebo
Keywords: Diabetes Mellitus, Drug Therapy, Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus, Hyperinsulinism, Insulin Resistance
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2, Hyperinsulinism, Insulin Resistance

What participants receive

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

AlogliptinDrug
Also called SYR-322, SYR110322
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
AlogliptinDrug
Also called SYR-322, SYR110322
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
AlogliptinDrug
Also called SYR-322, SYR110322
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
AlogliptinDrug
Also called SYR-322, SYR110322
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
AlogliptinDrug
Also called SYR-322, SYR110322
Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
PlaceboDrug
Alogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.

Study groups in NCT00755846
Study group	Role	What they receive
Alogliptin 6.25 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Alogliptin 12.5 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Alogliptin 25 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Alogliptin 50 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Alogliptin 100 mg QD	Experimental	Not described Receives: Drug: Alogliptin
Placebo QD	Placebo comparator	Not described Receives: Drug: Placebo

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 Day 85.
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 day 85 or final visit and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Day 85.

Secondary outcomes (14)

Change From Baseline in Glycosylated Hemoglobin at Day 43.
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 day 43 and glycosylated hemoglobin collected at baseline.
Measured: Baseline and Day 43.
Change From Baseline in Fasting Plasma Glucose (Day 43).
The change between the value of fasting plasma glucose collected at day 43 and fasting plasma glucose collected at baseline.
Measured: Baseline and Day 43
Change From Baseline in Fasting Plasma Glucose (Day 85).
The change between the value of fasting plasma glucose collected at day 85 or final visit and fasting plasma glucose collected at baseline.
Measured: Baseline and Day 85.
Change From Baseline in Fasting Fructosamine (Day 43).
The change between the value of fasting fructosamine collected at day 43 and fasting fructosamine collected at baseline.
Measured: Baseline and Day 43.
Change From Baseline in Fasting Fructosamine (Day 85).
The change between the value of fasting fructosamine collected at day 85 or final visit and fasting fructosamine collected at baseline.
Measured: Baseline and Day 85.
Change From Baseline in Total Cholesterol (Day 43).
The change between the value of cholesterol collected at day 43 and cholesterol collected at baseline.
Measured: Baseline and Day 43
Change From Baseline in Total Cholesterol (Day 85).
The change between the value of cholesterol collected at day 85 or final visit and cholesterol collected at baseline.
Measured: Baseline and Day 85.
Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).
The change between high-density lipoprotein cholesterol collected at day 43 and high-density lipoprotein cholesterol collected at baseline.
Measured: Baseline and Day 43.
Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).
The change between high-density lipoprotein cholesterol collected at day 85 or final visit and high-density lipoprotein cholesterol collected at baseline.
Measured: Baseline and Day 85.
Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).
The change between low-density lipoprotein cholesterol collected at day 43 and low-density lipoprotein cholesterol collected at baseline.
Measured: Baseline and Day 43.
Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).
The change between low-density lipoprotein cholesterol collected at day 85 or final visit and low-density lipoprotein cholesterol collected at baseline.
Measured: Baseline and Day 85.
Change From Baseline in Triglycerides (Day 43).
The change between triglycerides collected at day 43 and triglycerides collected at baseline.
Measured: Baseline and Day 43.
Change From Baseline in Triglycerides (Day 85).
The change between triglycerides collected at day 85 or final visit and triglycerides collected at baseline.
Measured: Baseline and Day 85.
Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).
The incidence of marked hyperglycemia occurring in participants with a fasting plasma glucose value greater than or equal to 200 mg per dL during study. Overall mean obtained by weighting the hyperglycemia percent incidence values at each time point by number of days in between visits. Mean percent incidence of marked hyperglycemia at each time point is the percent of self-monitored blood glucose measurements greater than or equal to 200 mg per dL, calculated per participant and then averaged across population.
Measured: 85 Days.

Timeline

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

Mar 2005Oct 2005

First posted19 Sep 2008 (estimated)
Study startMar 2005
Primary completionOct 2005
Study completionOct 2005

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 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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 265 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00755846
Sponsor's protocol ID: SYR-322-003
Other IDs: U1111-1113-8352
Status last verified: Feb 2012
First submitted: 17 Sep 2008
Last updated: 3 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.
PubMed 19793357

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 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 Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparison Study to Determine the Efficacy and Safety of SYR110322 in Patients With Type 2 Diabetes, Who Are Either Receiving No Current Treatment or Currently Treated With Diet and Exercise, Sulfonylurea, Metformin or a Combination of Sulfonylurea and Metformin
ClinicalTrials.gov ID: NCT00755846
Acronym / sponsor ID: SYR-322-003
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus, Drug Therapy, Diabetes Mellitus, Type II, Type 2 Diabetes Mellitus, Hyperinsulinism, Insulin Resistance
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 265 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Mar 2005
Primary completion: Oct 2005 (actual)
Study completion: Oct 2005 (actual)
First posted: 19 Sep 2008 (estimated)
Results: Posted 29 Aug 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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Alogliptin 6.25 mg QD	Experimental	Drug: Alogliptin
Alogliptin 12.5 mg QD	Experimental	Drug: Alogliptin
Alogliptin 25 mg QD	Experimental	Drug: Alogliptin
Alogliptin 50 mg QD	Experimental	Drug: Alogliptin
Alogliptin 100 mg QD	Experimental	Drug: Alogliptin
Placebo QD	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (22 listed)

Has type 2 diabetes mellitus and were either receiving no current treatment or currently treated with a sulfonylurea, metformin, or a combination of a sulfonylurea and metformin but experiencing inadequate glycemic control. Subjects qualified as receiving no current treatment if 1 of the following conditions applied:
Body mass index ≥23 kg/m2 and ≤40 kg/m2.
Fasting C-peptide concentration ≥0.8 ng/mL.
Glycosylated hemoglobin concentration between 6.8% and 11.0%.
Fasting plasma glucose >126 mg/dL at Screening.

Key exclusion criteria (15 listed)

History of cancer, other than squamous cell or basal cell carcinoma of the skin, that had not been in full remission for at least 1 year prior to Screening.
History of proteinuria >1000 mg/day on a 12- or 24-hour urine collection OR a urine albumin/creatinine ratio >1000 μg/mg at Screening. If elevated, the subject was to be rescreened within 1 week.
Serum creatinine ≥2.0 mg/dL.
History of proliferative diabetic retinopathy OR any history of laser-treated retinopathy.
History of treated peripheral or autonomic neuropathy.

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
AlogliptinAlso: SYR-322, SYR110322Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks	Drug	Alogliptin 6.25 mg QD
AlogliptinAlso: SYR-322, SYR110322Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.	Drug	Alogliptin 12.5 mg QD
AlogliptinAlso: SYR-322, SYR110322Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.	Drug	Alogliptin 25 mg QD
AlogliptinAlso: SYR-322, SYR110322Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.	Drug	Alogliptin 50 mg QD
AlogliptinAlso: SYR-322, SYR110322Alogliptin 100 mg, tablets, orally, once daily for up to 12 weeks.	Drug	Alogliptin 100 mg QD
PlaceboAlogliptin placebo-matching tablets, orally, once daily for up to 12 weeks.	Drug	Placebo QD

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.
Time frame: Baseline and Day 85.
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 day 85 or final visit and glycosylated hemoglobin collected at baseline.

14 secondary outcomes

Change From Baseline in Glycosylated Hemoglobin at Day 43.
Time frame: Baseline and Day 43.
Change From Baseline in Fasting Plasma Glucose (Day 43).
Time frame: Baseline and Day 43
Change From Baseline in Fasting Plasma Glucose (Day 85).
Time frame: Baseline and Day 85.
Change From Baseline in Fasting Fructosamine (Day 43).
Time frame: Baseline and Day 43.
Change From Baseline in Fasting Fructosamine (Day 85).
Time frame: Baseline and Day 85.
Change From Baseline in Total Cholesterol (Day 43).
Time frame: Baseline and Day 43
Change From Baseline in Total Cholesterol (Day 85).
Time frame: Baseline and Day 85.
Change From Baseline in High-Density Lipoprotein Cholesterol (Day 43).
Time frame: Baseline and Day 43.
Change From Baseline in High-Density Lipoprotein Cholesterol (Day 85).
Time frame: Baseline and Day 85.
Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 43).
Time frame: Baseline and Day 43.
Change From Baseline in Low-Density Lipoprotein Cholesterol (Day 85).
Time frame: Baseline and Day 85.
Change From Baseline in Triglycerides (Day 43).
Time frame: Baseline and Day 43.
Change From Baseline in Triglycerides (Day 85).
Time frame: Baseline and Day 85.
Mean Percent Incidence of Marked Hyperglycemia (Fasting Plasma Glucose ≥ 200 mg/dL).
Time frame: 85 Days.

Results and safety

Results posted to the registry on 29 Aug 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
Placebo QD	43	18
Alogliptin 6.25 mg QD	44	27
Alogliptin 12.5 mg QD	44	32
Alogliptin 25 mg QD	45	32
Alogliptin 50 mg QD	44	27
Alogliptin 100 mg QD	45	31

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85.

Time frame: Baseline and Day 85.. Least squares mean (Standard Error). Unit: percentage of Glycosylated Hemoglobin

Measure	Placebo QD n = 41	Alogliptin 6.25 mg QD n = 42	Alogliptin 12.5 mg QD n = 42	Alogliptin 25 mg QD n = 45	Alogliptin 50 mg QD n = 43	Alogliptin 100 mg QD n = 44
Value	-0.01 (0.135)	-0.19 (0.121)	-0.54 (0.122)	-0.56 (0.117)	-0.44 (0.124)	-0.51 (0.119)

Placebo QD vs Alogliptin 6.25 mg QD vs Alogliptin 12.5 mg QD vs Alogliptin 25 mg QD vs Alogliptin 50 mg QD vs Alogliptin 100 mg QD: Mean Difference (Final Values): -0.43, p = 0.001, ANCOVA
Placebo QD vs Alogliptin 100 mg QD: Mean Difference (Final Values): -0.50, p = 0.004, ANCOVA
Placebo QD vs Alogliptin 50 mg QD: Mean Difference (Net): -0.42, p = 0.017, ANCOVA

Population analysed: Randomized subjects who received at least 1 dose of study drug (Intent to Treat), and who had measurements at baseline and at Day 85. Missing data are imputed using last observation carried forward (LOCF).

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and no more than 14 days after the last dose of double-blind drug.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo QD	2 of 41 (4.9%)	14 of 41 (34.1%)	Not reported
Alogliptin 6.25 mg QD	1 of 42 (2.4%)	12 of 42 (28.6%)	Not reported
Alogliptin 12.5 mg QD	0 of 44 (0%)	18 of 44 (40.9%)	Not reported
Alogliptin 25 mg QD	1 of 45 (2.2%)	19 of 45 (42.2%)	Not reported
Alogliptin 50 mg QD	0 of 43 (0%)	15 of 43 (34.9%)	Not reported
Alogliptin 100 mg QD	0 of 44 (0%)	22 of 44 (50%)	Not reported

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.
Results publication: PubMed 19793357Pratley RE, McCall T, Fleck PR, Wilson CA, Mekki Q. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x. Epub 2009 Sep 30.

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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.

VP Biological Sciences study director

Takeda

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Alogliptin in people with 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 22 inclusion and 15 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 29 Aug 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?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Day 85. (time frame: Baseline and Day 85.). 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 NCT00755846, 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 3 Feb 2012.