Type 2 Diabetes MellitusPhase 3NCT01703221

Omarigliptin (MK-3102) Clinical Trial - Placebo- and Sitagliptin-Controlled Monotherapy Study in Japanese Patients With Type 2 Diabetes Mellitus (MK-3102-020)

A Phase 3 study testing Omarigliptin and Sitagliptin 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

Search all trials

Trial summary

Who is it for?: Ages 20 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Omarigliptin and Sitagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 414 participants
Where: No sites listed yet
Study dates: 24 Oct 2012to 25 Apr 2014
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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has type 2 diabetes mellitus

Who cannot join

History of type 1 diabetes mellitus or a history of ketoacidosis
History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime

About this study

Official title: A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy

The purpose of this study is to assess the efficacy of omarigliptin 25 mg weekly (as monotherapy) compared with sitagliptin 50 mg daily and placebo, and the long term safety (up to 52 weeks) of omarigliptin 25 mg weekly. The primary hypotheses are that after 24 weeks: 1) Omarigliptin 25 mg weekly provides a greater reduction from baseline in glycosylated hemoglobin (HbA1c) compared with placebo, and 2) The mean change from baseline in HbA1c in participants treated with omarigliptin 25 mg weekly is non-inferior compared with that in participants treated with sitagliptin 50 mg daily.

Read the detailed description

The treatment period is composed of a 24-week double-blind period (Phase A) and a 28-week open-label period (Phase B). Participants will receive in Phase A: omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo and in Phase B: omarigliptin 25 mg once weekly.

Conditions: Type 2 Diabetes Mellitus
Being tested: Omarigliptin, Sitagliptin, Placebo to omarigliptin, Placebo to sitagliptin
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.

OmarigliptinDrug
Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
SitagliptinDrug
Also called Januvia®
Sitagliptin 50 mg tablet administered orally once daily
Placebo to omarigliptinDrug
Placebo to omarigliptin 25 mg capsule administered orally once weekly
Placebo to sitagliptinDrug
Placebo to sitagliptin 50 mg tablet administered orally once daily

Study groups in NCT01703221
Study group	Role	What they receive
Omarigliptin 25 mg (Phase A+B)	Experimental	Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B) Receives: Drug: Omarigliptin; Drug: Placebo to sitagliptin
Sitagliptin (Phase A) switching to Omarigliptin (Phase B)	Active comparator	Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) Receives: Drug: Omarigliptin; Drug: Sitagliptin; Drug: Placebo to omarigliptin
Placebo (Phase A) switching to Omarigliptin (Phase B)	Placebo comparator	Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B) Receives: Drug: Omarigliptin; Drug: Placebo to omarigliptin; Drug: Placebo to sitagliptin

What is being measured

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

Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
Measured: Baseline and Week 24
Percentage of Participants Who Experienced at Least One Adverse Event During Phase A
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to 24 weeks
Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
Measured: Up to 52 weeks
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Measured: Up to 24 weeks
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
Measured: Up to 52 weeks

Secondary outcomes (2)

Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24
Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
Measured: Baseline and Week 24
Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24
Blood glucose was measured on a fasting basis. FPG is expressed as mg/dL. Blood was drawn at predose on Day 1 and after 24 weeks of treatment to determine change in plasma glucose levels (i.e., FPG at Week 24 minus FPG at baseline).
Measured: Baseline and Week 24

Timeline

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

24 Oct 201225 Apr 2014

First posted10 Oct 2012 (estimated)
Study start24 Oct 2012
Primary completion25 Apr 2014
Study completion25 Apr 2014

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 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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 414 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01703221
Sponsor's protocol ID: 3102-020
Other IDs: 132239
Status last verified: Aug 2019
First submitted: 5 Oct 2012
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Gantz I, Okamoto T, Ito Y, Okuyama K, O'Neill EA, Kaufman KD, Engel SS, Lai E; the Omarigliptin Study 020 Group. A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1602-1609. doi: 10.1111/dom.12988. Epub 2017 Jul 6.
PubMed 28449368

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 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Multicenter, Randomized, Placebo- and Sitagliptin-controlled, Parallel-group, Double-blinded Study and Subsequent Open-label, Extension Study to Assess the Safety and Efficacy of MK-3102 in Japanese Patients With Type 2 Diabetes Mellitis Who Have Inadequate Glycemic Control on Diet/Exercise Therapy
ClinicalTrials.gov ID: NCT01703221
Acronym / sponsor ID: 3102-020
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 414 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 24 Oct 2012 (actual)
Primary completion: 25 Apr 2014 (actual)
Study completion: 25 Apr 2014 (actual)
First posted: 10 Oct 2012 (estimated)
Results: Posted 29 Oct 2015

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Omarigliptin 25 mg (Phase A+B)	Experimental	Drug: Omarigliptin, Drug: Placebo to sitagliptinOmarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
Sitagliptin (Phase A) switching to Omarigliptin (Phase B)	Active comparator	Drug: Omarigliptin, Drug: Sitagliptin, Drug: Placebo to omarigliptinSitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
Placebo (Phase A) switching to Omarigliptin (Phase B)	Placebo comparator	Drug: Omarigliptin, Drug: Placebo to omarigliptin, Drug: Placebo to sitagliptinPlacebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Has type 2 diabetes mellitus

Key exclusion criteria (2 listed)

History of type 1 diabetes mellitus or a history of ketoacidosis
History of any of the following medications: thiazolidinediones and/or insulin within 12 weeks prior to study participation, omarigliptin and/or sitagliptin anytime

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
OmarigliptinOmarigliptin (MK-3102) 25 mg capsule administered orally once weekly	Drug	Omarigliptin 25 mg (Phase A+B), Placebo (Phase A) switching to Omarigliptin (Phase B), Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
SitagliptinAlso: Januvia®Sitagliptin 50 mg tablet administered orally once daily	Drug	Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
Placebo to omarigliptinPlacebo to omarigliptin 25 mg capsule administered orally once weekly	Drug	Placebo (Phase A) switching to Omarigliptin (Phase B), Sitagliptin (Phase A) switching to Omarigliptin (Phase B)
Placebo to sitagliptinPlacebo to sitagliptin 50 mg tablet administered orally once daily	Drug	Omarigliptin 25 mg (Phase A+B), Placebo (Phase A) switching to Omarigliptin (Phase B)

Primary outcome

Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24
Time frame: Baseline and Week 24
HbA1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline).
Percentage of Participants Who Experienced at Least One Adverse Event During Phase A
Time frame: Up to 24 weeks
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study
Time frame: Up to 52 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A
Time frame: Up to 24 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During the Overall Study
Time frame: Up to 52 weeks
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. These results represent the accrual of events over different treatment intervals: 52 weeks, omarigliptin (Phase A+B) defined as the double-blind period and open label extension period versus 28 weeks for the Sitagliptin (Phase A)→Omarigliptin (Phase B) and placebo (Phase A)→Omarigliptin (Phase B) group defined as the open-label extension period only.

2 secondary outcomes

Change From Baseline for 2-hour Post Meal Glucose (PMG) at Week 24
Time frame: Baseline and Week 24
Change From Baseline for Fasting Plasma Glucose (FPG) at Week 24
Time frame: Baseline and Week 24

Results and safety

Results posted to the registry on 29 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omarigliptin (Phase A+B)	166	159
Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)	165	161
Placebo (Phase A) Switching to Omarigliptin (Phase B)	83	80

Primary outcome: Change From Baseline for Hemoglobin A1c (HbA1c) at Week 24

Time frame: Baseline and Week 24. Least squares mean (95% Confidence Interval). Unit: Percent HbA1c

Measure	Omarigliptin (Phase A) n = 166	Sitagliptin (Phase A) n = 164	Placebo (Phase A) n = 82
Value	-0.66 (-0.76 to -0.57)	-0.65 (-0.74 to -0.55)	0.13 (-0.00 to 0.27)

Omarigliptin (Phase A) vs Placebo (Phase A): Difference in the least squares means: -0.80 (95% CI -0.96 to -0.63), p <0.001, Constrained longitudinal analysis
Sitagliptin (Phase A) vs Placebo (Phase A): Difference in the least squares means: -0.78 (95% CI -0.94 to -0.61), p <0.001, Constrained longitudinal analysis
Omarigliptin (Phase A) vs Sitagliptin (Phase A): Difference in the least squares means: -0.02 (95% CI -0.15 to 0.12), p = 0.792, Constrained longitudinal analysis

Population analysed: The Full Analysis Set (FAS) consisted of all randomized participants who had at least one study drug and had a baseline or post-randomization measurement for this outcome measure.

Primary outcome: Percentage of Participants Who Experienced at Least One Adverse Event During Phase A

Time frame: Up to 24 weeks. Number. Unit: Percentage of participants

Measure	Omarigliptin (Phase A) n = 166	Sitagliptin (Phase A) n = 164	Placebo (Phase A) n = 82
Value	50.0	49.4	65.9

Population analysed: All Subjects as Treated (ASaT) population consisted of all randomized participants who received at least one study drug.

Primary outcome: Percentage of Participants Who Experienced at Least One Adverse Event During the Overall Study

Time frame: Up to 52 weeks. Number. Unit: Percentage of Participants

Measure	Omarigliptin (Phase A+B) n = 166	Omarigliptin (Phase B)-S n = 161	Omarigliptin (Phase B)-P n = 80
Value	69.9	47.2	56.3

Population analysed: The ASaT Population included all randomized participants who received at least one study drug. Data was unavailable for 7 participants who discontinued the study in sitagliptin and placebo arms in Phase A.

Primary outcome: Percentage of Participants Who Discontinued From the Study Due to an Adverse Event During Phase A

Time frame: Up to 24 weeks. Number. Unit: Percentage of participants

Measure	Omarigliptin (Phase A) n = 166	Sitagliptin (Phase A) n = 164	Placebo (Phase A) n = 82
Value	0.6	1.2	0

Population analysed: The ASaT Population consisted of all randomized participants who received at least one study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Phase A (up to 24 weeks), Phase B (Up to 28 weeks [Week 25 to 52]), Phase A+B (up to 52 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omarigliptin (Phase A)	3 of 166 (1.8%)	21 of 166 (12.7%)	Not reported
Sitagliptin (Phase A)	3 of 164 (1.8%)	18 of 164 (11%)	Not reported
Placebo (Phase A)	0 of 82 (0%)	25 of 82 (30.5%)	Not reported
Omarigliptin (Phase A + B)	6 of 166 (3.6%)	45 of 166 (27.1%)	Not reported
Omarigliptin (Phase B)-S	2 of 161 (1.2%)	22 of 161 (13.7%)	Not reported
Omarigliptin (Phase B)-P	0 of 80 (0%)	17 of 80 (21.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28449368Gantz I, Okamoto T, Ito Y, Okuyama K, O'Neill EA, Kaufman KD, Engel SS, Lai E; the Omarigliptin Study 020 Group. A randomized, placebo- and sitagliptin-controlled trial of the safety and efficacy of omarigliptin, a once-weekly dipeptidyl peptidase-4 inhibitor, in Japanese patients with type 2 diabetes. Diabetes Obes Metab. 2017 Nov;19(11):1602-1609. doi: 10.1111/dom.12988. Epub 2017 Jul 6.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omarigliptin and Sitagliptin in people with Type 2 Diabetes Mellitus, run by Merck Sharp & Dohme LLC.

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 1 inclusion and 2 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 28 Aug 2019. 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 29 Oct 2015). 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 for Hemoglobin A1c (HbA1c) at Week 24 (time frame: Baseline and Week 24). The study lists 5 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 NCT01703221, 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 28 Aug 2019.