Type 2 Diabetes MellitusPhase 3NCT00103857

MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)

A Phase 3 study testing Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily), Comparator: MK0431 100 mg q.d. (q.d. = once daily) and Comparator: Metformin 500 mg b.i.d. in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes). Read more about this study

Who is it for?: Ages 18 to 78 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily), Comparator: MK0431 100 mg q.d. (q.d. = once daily) and Comparator: Metformin 500 mg b.i.d.
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,208 participants
Where: No sites listed yet
Study dates: 17 Mar 2005to 21 Feb 2008
Phase: Phase 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 18 to 78 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

54-Week Base Study:
Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)
50-Week Extension Study:
Patients who complete the 54-week base study are eligible to enter the 50-week extension study

Who cannot join

Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)

About this study

Official title: A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).

Conditions: Type 2 Diabetes Mellitus
Being tested: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily), Comparator: MK0431 100 mg q.d. (q.d. = once daily), Comparator: Placebo (Phase A)/Metformin (Phase B), Comparator: Metformin 500 mg b.i.d., Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.
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.

Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)Drug
Also called MK0431
MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
Comparator: MK0431 100 mg q.d. (q.d. = once daily)Drug
MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
Comparator: Placebo (Phase A)/Metformin (Phase B)Drug
During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks.
Comparator: Metformin 500 mg b.i.d.Drug
Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.Drug
MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks.
Comparator: Metformin 1000 mg b.i.d.Drug
Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.

Study groups in NCT00103857
Study group	Role	What they receive
1	Experimental	MK0431 100 mg q.d. Receives: Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily)
2	Active comparator	Metformin 500 mg b.i.d. Receives: Drug: Comparator: Metformin 500 mg b.i.d.
3	Active comparator	Metformin 1000 mg b.i.d. Receives: Drug: Comparator: Metformin 1000 mg b.i.d.
4	Experimental	Coadministration of MK0431 and Metformin 50/500 mg b.i.d. Receives: Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily); Drug: Comparator: Metformin 500 mg b.i.d.
5	Experimental	Coadministration of MK0431 and Metformin 50/1000 mg b.i.d. Receives: Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily); Drug: Comparator: Metformin 1000 mg b.i.d.
6	Placebo comparator	Placebo/Metformin 1000 mg b.i.d. Receives: Drug: Comparator: Placebo (Phase A)/Metformin (Phase B)
7	Experimental	Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d. Receives: Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.

What is being measured

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

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Measured: Week 24

Secondary outcomes (8)

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Measured: Week 24
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24
Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Measured: Week 24
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54
HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
Measured: Week 54
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54
Change from baseline at Week 54 is defined as Week 54 minus Week 0.
Measured: Week 54
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54
Change from baseline at Week 54 is defined as Week 54 minus Week 0.
Measured: Week 54
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104
HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
Measured: Week 104
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Measured: Week 104
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104
Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Measured: Week 104

Timeline

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

17 Mar 200521 Feb 2008

First posted16 Feb 2005 (estimated)
Study start17 Mar 2005
Primary completion25 Jul 2006
Study completion21 Feb 2008

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 (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00103857
Sponsor's protocol ID: 0431-036
Other IDs: MK0431-036, 2005_003
Status last verified: Mar 2017
First submitted: 15 Feb 2005
Last updated: 5 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007 Aug;30(8):1979-87. doi: 10.2337/dc07-0627. Epub 2007 May 7.
PubMed 17485570
Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
PubMed 32501595

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 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
ClinicalTrials.gov ID: NCT00103857
Acronym / sponsor ID: 0431-036
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,208 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 17 Mar 2005 (actual)
Primary completion: 25 Jul 2006 (actual)
Study completion: 21 Feb 2008 (actual)
First posted: 16 Feb 2005 (estimated)
Results: Posted 19 May 2009

Clinical summary

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

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
1	Experimental	Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily)MK0431 100 mg q.d.
2	Active comparator	Drug: Comparator: Metformin 500 mg b.i.d.Metformin 500 mg b.i.d.
3	Active comparator	Drug: Comparator: Metformin 1000 mg b.i.d.Metformin 1000 mg b.i.d.
4	Experimental	Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily), Drug: Comparator: Metformin 500 mg b.i.d.Coadministration of MK0431 and Metformin 50/500 mg b.i.d.
5	Experimental	Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily), Drug: Comparator: Metformin 1000 mg b.i.d.Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.
6	Placebo comparator	Drug: Comparator: Placebo (Phase A)/Metformin (Phase B)Placebo/Metformin 1000 mg b.i.d.
7	Experimental	Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.

Who may qualify

Ages: 18 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)
Patients who complete the 54-week base study are eligible to enter the 50-week extension study

Key exclusion criteria (1 listed)

Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)

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
Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)Also: MK0431MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.	Drug	4, 5
Comparator: MK0431 100 mg q.d. (q.d. = once daily)MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.	Drug	1
Comparator: Placebo (Phase A)/Metformin (Phase B)During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks.	Drug	6
Comparator: Metformin 500 mg b.i.d.Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.	Drug	2, 4
Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks.	Drug	7
Comparator: Metformin 1000 mg b.i.d.Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.	Drug	3, 5

Primary outcome

Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
Time frame: Week 24
HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

8 secondary outcomes

Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
Time frame: Week 24
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24
Time frame: Week 24
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54
Time frame: Week 54
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54
Time frame: Week 54
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54
Time frame: Week 54
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104
Time frame: Week 104
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104
Time frame: Week 104
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104
Time frame: Week 104

Results and safety

Results posted to the registry on 19 May 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitagliptin 100 mg q.d.	179	122
Metformin 500 mg b.i.d.	182	126
Metformin 1000 mg b.i.d.	182	135
Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.	190	148
Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.	182	141
Placebo/Metformin 1000 mg b.i.d.	176	115
Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC	117	79

Primary outcome: Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24

Time frame: Week 24. Least squares mean (95% Confidence Interval). Unit: Percent

Measure	Sitagliptin 100 mg q.d. n = 175	Metformin 500 mg b.i.d. n = 178	Metformin 1000 mg b.i.d. n = 177	Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. n = 183	Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. n = 178	Placebo/Metformin 1000 mg b.i.d. n = 165
Value	-0.66 (-0.83 to -0.50)	-0.82 (-0.98 to -0.66)	-1.13 (-1.29 to -0.97)	-1.40 (-1.56 to -1.24)	-1.90 (-2.06 to -1.74)	0.17 (0.00 to 0.33)

Population analysed: The Full Analysis Set (FAS) included all patients with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. For FAS patients with no data at Week 24, the last observed measurement was carried forward to Week 24. The Open-label Cohort group was excluded from the FAS.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin 100 mg q.d.	15 of ?	71 of ?	Not reported
Metformin 500 mg b.i.d.	10 of ?	74 of ?	Not reported
Metformin 1000 mg b.i.d.	14 of ?	99 of ?	Not reported
Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.	17 of ?	87 of ?	Not reported
Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.	13 of ?	94 of ?	Not reported
Placebo/Metformin 1000 mg b.i.d.	23 of ?	73 of ?	Not reported
Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC	3 of ?	40 of ?	Not reported

Limitations and caveats (from the sponsor): Non-serious adverse experience results represent those events included in the primary safety analysis for this study (i.e., events that occurred prior to the initiation of glycemic rescue therapy).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17485570Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007 Aug;30(8):1979-87. doi: 10.2337/dc07-0627. Epub 2007 May 7.
Derived from this study: PubMed 32501595Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.

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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 Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

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 4 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 5 May 2017. 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 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 19 May 2009). 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 HbA1c (Hemoglobin A1C) at Week 24 (time frame: Week 24). 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 NCT00103857, which also lists 2 linked publications.

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 5 May 2017.