Diabetes Mellitus, Type 2Phase 3NCT01289119

Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes

A Phase 3 study testing Alogliptin, Metformin and Pioglitazone in people with Diabetes Mellitus, Type 2, run by Takeda at 21 sites in 3 countries.

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

The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Alogliptin, Metformin and Pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 506 participants
Where: 21 sitesin 3 countries
Study dates: Dec 2010to Dec 2011
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Has a historical diagnosis of Type 2 Diabetes Mellitus.
Has a body mass index between acceptable range.
Is experiencing inadequate glycemic control.
Body weight keeps constant.
Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.

Who cannot join

Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
Has a systolic blood pressure beyond the acceptable range at Screening visit.
Has New York Heart Association Class III or IV heart failure regardless of therapy.
Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.

Trial locations and contacts

21 sites in 3 countries.

Country

City, postcode or hospital

21 sites in 3 countries

China19 sites

Study site
Beijing, Beijing Municipality
Study site
Changchun, Jilin
Study site
Changsha, Hunan
Study site
Fuzhou, Fujian
Study site
Guangzhou, Guangdong
Study site
Haikou, Hainan
Study site
Hangzhou, Zhejiang
Study site
Harbin, Heilongjiang
Study site
Jinan, Shandong
Study site
Jingzhou, Hubei
Study site
Kunming, Yunnan
Study site
Nanchang, Jiangxi
Study site
Shanghai, Shanghai Municipality
Study site
Shenyang, Liaoning
Study site
Shiyan, Hubei
Study site
Tianjin, Tianjin Municipality
Study site
Wuxi, Jiangsu
Study site
Xi’an, Shanxi
Study site
Xiamen, Fujian

Other trials in China

Hong Kong1 site

Study site
Hong Kong, Hong Kong

Other trials in Hong Kong

Taiwan1 site

Study site
Taipei County

Other trials in Taiwan

About this study

Official title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Determine the Efficacy and Safety of SYR-322 When Used in Subjects With Type 2 Diabetes

The purpose of the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

Read the detailed description

Diabetes is a chronic illness associated with microvascular complications such as nephropathy (kidney disease), retinopathy (eye damage) and neuropathy (nervous system damage). Diabetes is also associated with macrovascular complications including cardiovascular disease (heart disease), stroke and peripheral vascular disease (narrowing or blockage of blood vessels). These complications are associated with reduced quality of life and increased morbidity and mortality.

Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients with Type 2 diabetes mellitus.

Evaluations of alogliptin and its clinical efficacy have been conducted in multiple countries including the United States and Japan. This study will be conducted as a multi-center clinical trial in order to validate the efficacy and safety of alogliptin on type 2 diabetes population within Asia.

Participants who qualified for the study were stratified into 1 of the 3 therapy groups based upon their background antidiabetic therapy before being randomized 1:1 to receive either alogliptin 25 mg once daily or matching placebo once daily.

Monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening.
Add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening.
Add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.

Conditions: Diabetes Mellitus, Type 2
Being tested: Alogliptin, Placebo to alogliptin, Metformin, Pioglitazone
Keywords: Type 2 Diabetes Mellitus, Drug Therapy
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

AlogliptinDrug
Also called SYR-322
Alogliptin tablets
Placebo to alogliptinDrug
Alogliptin placebo-matching tablets.
MetforminDrug
Also called Fortamet, Glucophage, Glumetza
Stable metformin dose
PioglitazoneDrug
Also called Actos
Stable pioglitazone dose

Study groups in NCT01289119
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. Receives: Drug: Placebo to alogliptin
Alogliptin Monotherapy	Experimental	Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. Receives: Drug: Alogliptin
Metformin	Other	Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. Receives: Drug: Placebo to alogliptin; Drug: Metformin
Metformin + Alogliptin Add-on Therapy	Experimental	Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks. Receives: Drug: Alogliptin; Drug: Metformin
Pioglitazone	Other	Participants continued to receive their stable dose of pioglitazone with or without metformin, and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks. Receives: Drug: Placebo to alogliptin; Drug: Pioglitazone
Pioglitazone + Alogliptin Add-on Therapy	Experimental	Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks. Receives: Drug: Alogliptin; Drug: Pioglitazone

What is being measured

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

Change From Baseline in Glycosylated Hemoglobin (HbA1c)
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.
Measured: Baseline and Week 16.

Secondary outcomes (11)

Change From Baseline in HbA1c Over Time
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Weeks 4, 8 and 12. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.
Measured: Baseline and Weeks 4, 8 and 12.
Change From Baseline in Fasting Plasma Glucose Over Time
The change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 8, 12 and 16. Least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline FPG as a covariate for the monotherapy, baseline FPG with baseline metformin dose as covariates for the metformin therapy, baseline FPG with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.
Measured: Baseline and Weeks 4, 8, 12 and 16.
Percentage of Participants With Marked Hyperglycemia
Marked Hyperglycemia was defined as fasting plasma glucose greater than or equal to 200 mg/dL (11.1 mmol/L).
Measured: Randomization to Week 16.
Change From Baseline in Body Weight
The change between body weight measured at Baseline and body weight measured at Weeks 8 and 16. The least squares means are derived from an ANCOVA model with treatment as a fixed effect, and baseline body weight as a covariate for the monotherapy, baseline body weight with baseline metformin dose as covariates for the add-on to metformin therapy, baseline body weight with baseline metformin therapy status and baseline pioglitazone dose as covariates for the add-on to pioglitazone therapy.
Measured: Baseline and Weeks 8 and 16.
Percentage of Participants With HbA1c ≤6.5% at Week 16
Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 6.5% at Week 16.
Measured: Week 16
Percentage of Participants With HbA1c ≤7.0% at Week 16
Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.0% at Week 16.
Measured: Week 16
Percentage of Participants With HbA1c ≤7.5% at Week 16
Clinical response was assessed by the percentage of participants with HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) less than or equal to 7.5% at Week 16.
Measured: Week 16
Percentage of Participants With a Decrease in HbA1c ≥ 0.5%
Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 0.5% at Week 16.
Measured: Baseline and Week 16
Percentage of Participants With a Decrease in HbA1c ≥1.0%
Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.0% at Week 16.
Measured: Baseline and Week 16
Percentage of Participants With a Decrease in HbA1c ≥1.5%
Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 1.5% at Week 16.
Measured: Baseline and Week 16.
Percentage of Participants With a Decrease in HbA1c ≥2.0%
Clinical response was assessed by the percentage of participants with a decrease from Baseline in HbA1c of greater than or equal to 2.0% at Week 16.
Measured: Baseline and Week 16.

Timeline

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

Dec 2010Dec 2011

First posted3 Feb 2011 (estimated)
Study startDec 2010
Primary completionDec 2011
Study completionDec 2011

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 Mellitus, Type 2Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 506 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01289119
Sponsor's protocol ID: SYR-322_02
Other IDs: U1111-1118-3681, SYR-322_308
Status last verified: Feb 2013
First submitted: 1 Feb 2011
Last updated: 22 Mar 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.pub2.
PubMed 38837240

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?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Determine the Efficacy and Safety of SYR-322 When Used in Subjects With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01289119
Acronym / sponsor ID: SYR-322_02
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus, Drug Therapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 506 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 3 Feb 2011 (estimated)
Results: Posted 22 Mar 2013

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 the study is to determine the efficacy of alogliptin compared to placebo when given alone or as add-on therapy to metformin or add-on to pioglitazone (with or without metformin).

Detailed description

Takeda is developing SYR-322 (alogliptin) for improvement of glycemic control in patients with Type 2 diabetes mellitus.

Monotherapy group - patients who had been treated with diet and exercise for at least 2 months prior to screening.
Add-on to metformin therapy group - patients who had been treated with metformin for at least 3 months and at a stable dose (≥1000 mg/day) for at least 8 weeks prior to screening.
Add-on to pioglitazone therapy group - patients who had been treated with a stable dose of pioglitazone alone or in combination with metformin at a stable dose for at least 8 weeks prior to screening.

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
Placebo	Placebo comparator	Drug: Placebo to alogliptinParticipants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Alogliptin Monotherapy	Experimental	Drug: AlogliptinParticipants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
Metformin	Other	Drug: Placebo to alogliptin, Drug: MetforminParticipants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Metformin + Alogliptin Add-on Therapy	Experimental	Drug: Alogliptin, Drug: MetforminParticipants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
Pioglitazone	Other	Drug: Placebo to alogliptin, Drug: PioglitazoneParticipants continued to receive their stable dose of pioglitazone with or without metformin, and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
Pioglitazone + Alogliptin Add-on Therapy	Experimental	Drug: Alogliptin, Drug: PioglitazoneParticipants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.

Who may qualify

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

Key inclusion criteria (5 listed)

Has a historical diagnosis of Type 2 Diabetes Mellitus.
Has a body mass index between acceptable range.
Is experiencing inadequate glycemic control.
Body weight keeps constant.
Females of childbearing potential and males who are sexually active agree to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.

Key exclusion criteria (5 listed)

Has participated in another clinical study within the past 90 days or has received any investigational compound within 30 days prior to randomization.
Has a systolic blood pressure beyond the acceptable range at Screening visit.
Has New York Heart Association Class III or IV heart failure regardless of therapy.
Has any major illness or debility that in the investigator's opinion prohibits the subject from completing the study.
Has a history of hypersensitivity or allergies to any DPP-4 inhibitor.

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-322Alogliptin tablets	Drug	Alogliptin Monotherapy, Metformin + Alogliptin Add-on Therapy, Pioglitazone + Alogliptin Add-on Therapy
Placebo to alogliptinAlogliptin placebo-matching tablets.	Drug	Metformin, Pioglitazone, Placebo
MetforminAlso: Fortamet, Glucophage, GlumetzaStable metformin dose	Drug	Metformin, Metformin + Alogliptin Add-on Therapy
PioglitazoneAlso: ActosStable pioglitazone dose	Drug	Pioglitazone, Pioglitazone + Alogliptin Add-on Therapy

Primary outcome

Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline and Week 16.
The change from Baseline in HbA1c (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Week 16. Least squares means are derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect, and baseline HbA1c as a covariate for the monotherapy, baseline HbA1c with baseline metformin dose as covariates for the metformin therapy, baseline HbA1c with baseline metformin therapy status and baseline pioglitazone dose as covariates for the pioglitazone therapy.

11 secondary outcomes

Change From Baseline in HbA1c Over Time
Time frame: Baseline and Weeks 4, 8 and 12.
Change From Baseline in Fasting Plasma Glucose Over Time
Time frame: Baseline and Weeks 4, 8, 12 and 16.
Percentage of Participants With Marked Hyperglycemia
Time frame: Randomization to Week 16.
Change From Baseline in Body Weight
Time frame: Baseline and Weeks 8 and 16.
Percentage of Participants With HbA1c ≤6.5% at Week 16
Time frame: Week 16
Percentage of Participants With HbA1c ≤7.0% at Week 16
Time frame: Week 16
Percentage of Participants With HbA1c ≤7.5% at Week 16
Time frame: Week 16
Percentage of Participants With a Decrease in HbA1c ≥ 0.5%
Time frame: Baseline and Week 16
Percentage of Participants With a Decrease in HbA1c ≥1.0%
Time frame: Baseline and Week 16
Percentage of Participants With a Decrease in HbA1c ≥1.5%
Time frame: Baseline and Week 16.
Percentage of Participants With a Decrease in HbA1c ≥2.0%
Time frame: Baseline and Week 16.

Results and safety

Results posted to the registry on 22 Mar 2013, 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	93	84
Alogliptin Monotherapy	92	83
Metformin	98	89
Metformin + Alogliptin Add-on Therapy	99	93
Pioglitazone	63	58
Pioglitazone + Alogliptin Add-on Therapy	61	57

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c)

Time frame: Baseline and Week 16.. Least squares mean (Standard Error). Unit: percentage glycosylated hemoglobin

Measure	Placebo n = 90	Alogliptin Monotherapy n = 90	Metformin n = 97	Metformin + Alogliptin Add-on Therapy n = 98	Pioglitazone n = 63	Pioglitazone + Alogliptin Add-on Therapy n = 60
Value	-0.42 (0.074)	-0.99 (0.074)	-0.22 (0.065)	-0.91 (0.065)	-0.25 (0.097)	-0.76 (0.101)

Placebo vs Alogliptin Monotherapy: LS Mean Difference: -0.58 (95% CI -0.78 to -0.37), p <0.001, ANCOVA
Metformin vs Metformin + Alogliptin Add-on Therapy: LS Mean Difference: -0.69 (95% CI -0.87 to -0.51), p <0.001, ANCOVA
Pioglitazone vs Pioglitazone + Alogliptin Add-on Therapy: LS Mean Difference: -0.52 (95% CI -0.75 to -0.28), p <0.001, ANCOVA

Population analysed: The full analysis set, consisting of all patients who received at least one dose of double-blind study drug and who had a baseline assessment and at least one post-baseline HbA1c assessment. Last observation carried forward was utilized.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events (TEAE) were defined as any adverse events that started on or after the date of the first dose of double-blind study drug and within 14 days after the date of the last dose of double-blind study drug.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 92 (2.2%)	11 of 92 (12%)	Not reported
Alogliptin Monotherapy	2 of 92 (2.2%)	12 of 92 (13%)	Not reported
Metformin	3 of 98 (3.1%)	8 of 98 (8.2%)	Not reported
Metformin + Alogliptin Add-on Therapy	0 of 99 (0%)	7 of 99 (7.1%)	Not reported
Pioglitazone	0 of 63 (0%)	14 of 63 (22.2%)	Not reported
Pioglitazone + Alogliptin Add-on Therapy	1 of 61 (1.6%)	18 of 61 (29.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38837240El-Damanawi R, Stanley IK, Staatz C, Pascoe EM, Craig JC, Johnson DW, Mallett AJ, Hawley CM, Milanzi E, Hiemstra TF, Viecelli AK. Metformin for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2024 Jun 4;6(6):CD013414. doi: 10.1002/14651858.CD013414.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.

Professor Study Chair study chair

Takeda

21 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alogliptin, Metformin and Pioglitazone in people with Diabetes Mellitus, Type 2, run by Takeda at 21 sites in 3 countries.

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 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in China, Hong Kong, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 22 Mar 2013). 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) (time frame: Baseline and Week 16.). 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 NCT01289119, 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 22 Mar 2013.