Diabetes Mellitus, Type 2Phase 3NCT01194830

Efficacy and Safety of Linagliptin (BI 1356) in Black/African Americans With Type 2 Diabetes With a MTT Sub-study

A Phase 3 study testing Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 93 sites in United States.

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

Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Linagliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 234 participants
Where: 93 sitesUnited States
Study dates: Sep 2010to Oct 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Dated written informed consent that is in accordance with GCP and local legislation.
Male and female Black / African American patients
Diagnosis of type 2 diabetes at least 3 months prior to the informed consent.
HbA1c more than or equal to 7.5% and less than or equal to 11% at Visit 1.
Patients are currently treatment-naive or being treated with up to one oral antidiabetic medication. Antidiabetic medication is to be unchanged for at least 10 weeks prior to the informed consent.
Age more than 18 and less than 80 years at Visit 1 (Screening).
BMI (Body Mass Index) less than 45 kg/m2 at Visit 1.

Who cannot join

Myocardial infarction (MI), stroke or transient ischemic attack (TIA) within 3 months of informed consent.
Type 1 diabetes.
Impaired hepatic function, defined by serum levels of either alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1.
Known prior hypersensitivity or allergy to the investigational product or its excipients.
Treatment with insulin within 3 months prior to informed consent.
Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within three months prior to informed consent or initiating therapy during the study.

Show all 18Show fewer

Any prior use of dipeptidyl peptidase-4 (DPP-4) inhibitors.
Glucagon-like peptide-1 (GLP-1) agonists are excluded 3 months prior to informed consent.
History of alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation as assessed by the Investigator.
Participation in another trial with an investigational drug within 3 months prior to informed consent or during the study.
Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who:
are nursing or pregnant
are not surgically sterile
or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intrauterine devices/systems (IUDs / IUSs), oral, implantable or injectable contraceptives, and vasectomised partners. No exceptions will be made.
Hormonal birth control should have been in use for at least three months prior to signing informed consent and continue at least until the next menstrual period after completing the study.
Current treatment with chronic use of systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent.
History of bariatric surgery.
Patients who have demonstrated an inability to be compliant (80-120%) with the dosing regimen during the placebo run-in period.

Trial locations and contacts

93 sites in 1 country.

City, postcode or hospital

93 sites in 1 country

United States93 sites

1218.75.096 Boehringer Ingelheim Investigational Site
Akron, Ohio
1218.75.071 Boehringer Ingelheim Investigational Site
Anaheim, California
1218.75.091 Boehringer Ingelheim Investigational Site
Anderson, South Carolina
1218.75.038 Boehringer Ingelheim Investigational Site
Asheboro, North Carolina
1218.75.006 Boehringer Ingelheim Investigational Site
Atco, New Jersey
1218.75.049 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1218.75.106 Boehringer Ingelheim Investigational Site
Bartow, Florida
1218.75.044 Boehringer Ingelheim Investigational Site
Baton Rouge, Louisiana
1218.75.099 Boehringer Ingelheim Investigational Site
Biloxi, Mississippi
1218.75.059 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1218.75.098 Boehringer Ingelheim Investigational Site
Bradenton, Florida
1218.75.024 Boehringer Ingelheim Investigational Site
Brentwood, Tennessee
1218.75.086 Boehringer Ingelheim Investigational Site
Brockton, Massachusetts
1218.75.031 Boehringer Ingelheim Investigational Site
Brooklyn, New York
1218.75.095 Boehringer Ingelheim Investigational Site
Brooklyn, New York
1218.75.067 Boehringer Ingelheim Investigational Site
Calhoun, Georgia
1218.75.004 Boehringer Ingelheim Investigational Site
Camden, New Jersey
1218.75.009 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1218.75.023 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1218.75.060 Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
1218.75.001 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1218.75.055 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1218.75.036 Boehringer Ingelheim Investigational Site
Chiefland, Florida
1218.75.018 Boehringer Ingelheim Investigational Site
Chino, California
1218.75.025 Boehringer Ingelheim Investigational Site
Collierville, Tennessee
1218.75.040 Boehringer Ingelheim Investigational Site
Colorado Springs, Colorado
1218.75.072 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
1218.75.090 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1218.75.053 Boehringer Ingelheim Investigational Site
Dallas, Texas
1218.75.078 Boehringer Ingelheim Investigational Site
Dayton, Ohio
1218.75.047 Boehringer Ingelheim Investigational Site
Denver, Colorado
1218.75.051 Boehringer Ingelheim Investigational Site
Detroit, Michigan
1218.75.016 Boehringer Ingelheim Investigational Site
Dunwoody, Georgia
1218.75.108 Boehringer Ingelheim Investigational Site
Essex, Maryland
1218.75.088 Boehringer Ingelheim Investigational Site
Flint, Michigan
1218.75.105 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1218.75.083 Boehringer Ingelheim Investigational Site
Fort Myers, Florida
1218.75.081 Boehringer Ingelheim Investigational Site
Garden Grove, California
1218.75.011 Boehringer Ingelheim Investigational Site
Germantown, Tennessee
1218.75.005 Boehringer Ingelheim Investigational Site
Greensboro, North Carolina
1218.75.068 Boehringer Ingelheim Investigational Site
Greenwood, South Carolina
1218.75.097 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1218.75.002 Boehringer Ingelheim Investigational Site
Hialeah, Florida
1218.75.107 Boehringer Ingelheim Investigational Site
High Point, North Carolina
1218.75.057 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.75.064 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.75.104 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.75.043 Boehringer Ingelheim Investigational Site
Houton, Texas
1218.75.042 Boehringer Ingelheim Investigational Site
Humboldt, Tennessee
1218.75.054 Boehringer Ingelheim Investigational Site
Huntsville, Alabama
1218.75.080 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
1218.75.020 Boehringer Ingelheim Investigational Site
Jacksonville, North Carolina
1218.75.065 Boehringer Ingelheim Investigational Site
Jupiter, Florida
1218.75.063 Boehringer Ingelheim Investigational Site
Lawrenceville, Georgia
1218.75.066 Boehringer Ingelheim Investigational Site
Little Rock, Alaska
1218.75.109 Boehringer Ingelheim Investigational Site
Los Angeles, California
1218.75.056 Boehringer Ingelheim Investigational Site
Marietta, Georgia
1218.75.030 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1218.75.050 Boehringer Ingelheim Investigational Site
Memphis, Tennessee
1218.75.007 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.75.029 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.75.045 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.75.084 Boehringer Ingelheim Investigational Site
Miami, Florida
1218.75.035 Boehringer Ingelheim Investigational Site
Mobile, Alabama
1218.75.017 Boehringer Ingelheim Investigational Site
Ocala, Florida
1218.75.069 Boehringer Ingelheim Investigational Site
Owensboro, Kentucky
1218.75.008 Boehringer Ingelheim Investigational Site
Pell City, Alaska
1218.75.037 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1218.75.082 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1218.75.012 Boehringer Ingelheim Investigational Site
Pinellas Park, Florida
1218.75.074 Boehringer Ingelheim Investigational Site
Port Orange, Florida
1218.75.026 Boehringer Ingelheim Investigational Site
Rosswell, Georgia
1218.75.022 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1218.75.079 Boehringer Ingelheim Investigational Site
Sandy Springs, Georgia
1218.75.034 Boehringer Ingelheim Investigational Site
Snellville, Georgia
1218.75.076 Boehringer Ingelheim Investigational Site
South Miami, Florida
1218.75.003 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
1218.75.039 Boehringer Ingelheim Investigational Site
St. Petersburg, Florida
1218.75.058 Boehringer Ingelheim Investigational Site
Sugar Land, Texas
1218.75.075 Boehringer Ingelheim Investigational Site
Tallahassee, Florida
1218.75.100 Boehringer Ingelheim Investigational Site
Tamarac, Florida
1218.75.015 Boehringer Ingelheim Investigational Site
Tampa, Florida
1218.75.033 Boehringer Ingelheim Investigational Site
Tomball, Texas
1218.75.102 Boehringer Ingelheim Investigational Site
Tomball, Texas
1218.75.101 Boehringer Ingelheim Investigational Site
Toney, Alabama
1218.75.010 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania
1218.75.028 Boehringer Ingelheim Investigational Site
Uniontown, Pennsylvania
1218.75.019 Boehringer Ingelheim Investigational Site
Virgnia Beach, Virginia
1218.75.094 Boehringer Ingelheim Investigational Site
Waco, Texas
1218.75.087 Boehringer Ingelheim Investigational Site
Watertown, Massachusetts
1218.75.103 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida
1218.75.092 Boehringer Ingelheim Investigational Site
Whitney, Texas
1218.75.027 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina

Other trials in United States

About this study

Official title: A Phase IIIb, 24-week, Randomised, Placebo-controlled, Double-blinded, Efficacy and Safety Study of Linagliptin (BI 1356) in Black/African American Patients With Type 2 Diabetes With a MTT Sub-study

Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study

Conditions: Diabetes Mellitus, Type 2
Being tested: Linagliptin, Placebo
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.

LinagliptinDrug
Active drug 1 tablet PO QD
PlaceboDrug
1 Tablet PO QD

Study groups in NCT01194830
Study group	Role	What they receive
Linagliptin	Active comparator	1 Tablet PO QD Receives: Drug: Linagliptin
Placebo	Placebo comparator	1 Tablet PO QD Receives: Drug: Placebo

What is being measured

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

Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Measured: baseline, 24 weeks

Secondary outcomes (8)

Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Measured: baseline, 6 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Measured: baseline, 12 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Measured: baseline, 18 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Measured: 24 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Measured: 24 weeks
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
Measured: 24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks
Measured: baseline, 24 weeks
Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks
Measured: baseline, 24 weeks

Timeline

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

Sep 2010Oct 2011

First posted3 Sep 2010 (estimated)
Study startSep 2010
Primary completionOct 2011
Study completionOct 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 (2)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 Boehringer IngelheimThe 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: Double blind
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01194830
Sponsor's protocol ID: 1218.75
Status last verified: Dec 2013
First submitted: 2 Sep 2010
Last updated: 29 Jan 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Lajara R, Aguilar R, Hehnke U, Woerle HJ, von Eynatten M. Efficacy and safety of linagliptin in subjects with long-standing type 2 diabetes mellitus (>10 years): evidence from pooled data of randomized, double-blind, placebo-controlled, phase III trials. Clin Ther. 2014 Nov 1;36(11):1595-605. doi: 10.1016/j.clinthera.2014.07.020. Epub 2014 Sep 16.
PubMed 25236917
Thrasher J, Daniels K, Patel S, Whetteckey J. Black/African American patients with type 2 diabetes mellitus: study design and baseline patient characteristics from a randomized clinical trial of linagliptin. Expert Opin Pharmacother. 2012 Dec;13(17):2443-52. doi: 10.1517/14656566.2012.740459. Epub 2012 Nov 8.
PubMed 23134211

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIIb, 24-week, Randomised, Placebo-controlled, Double-blinded, Efficacy and Safety Study of Linagliptin (BI 1356) in Black/African American Patients With Type 2 Diabetes With a MTT Sub-study
ClinicalTrials.gov ID: NCT01194830
Acronym / sponsor ID: 1218.75
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: Sep 2010
Primary completion: Oct 2011 (actual)
Study completion: Oct 2011 (actual)
First posted: 3 Sep 2010 (estimated)
Results: Posted 26 Oct 2012

Clinical summary

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

Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Linagliptin	Active comparator	Drug: Linagliptin1 Tablet PO QD
Placebo	Placebo comparator	Drug: Placebo1 Tablet PO QD

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Dated written informed consent that is in accordance with GCP and local legislation.
Male and female Black / African American patients
Diagnosis of type 2 diabetes at least 3 months prior to the informed consent.
HbA1c more than or equal to 7.5% and less than or equal to 11% at Visit 1.
Patients are currently treatment-naive or being treated with up to one oral antidiabetic medication. Antidiabetic medication is to be unchanged for at least 10 weeks prior to the informed consent.

Key exclusion criteria (18 listed)

Myocardial infarction (MI), stroke or transient ischemic attack (TIA) within 3 months of informed consent.
Type 1 diabetes.
Impaired hepatic function, defined by serum levels of either alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1.
Known prior hypersensitivity or allergy to the investigational product or its excipients.
Treatment with insulin within 3 months prior to informed consent.

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
LinagliptinActive drug 1 tablet PO QD	Drug	Linagliptin
Placebo1 Tablet PO QD	Drug	Placebo

Primary outcome

Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks
Time frame: baseline, 24 weeks
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin

8 secondary outcomes

Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks
Time frame: baseline, 6 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks
Time frame: baseline, 12 weeks
Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks
Time frame: baseline, 18 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks
Time frame: 24 weeks
Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks
Time frame: 24 weeks
Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks
Time frame: 24 weeks
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks
Time frame: baseline, 24 weeks
Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks
Time frame: baseline, 24 weeks

Results and safety

Results posted to the registry on 26 Oct 2012, 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 Tablet	124	88
Linagliptin 5 mg Tablet	110	83

Primary outcome: Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks

Time frame: baseline, 24 weeks. Least squares mean (Standard Error). Unit: Percentage

Measure	Placebo Tablet n = 105	Linagliptin 5 mg Tablet n = 93
Value	-0.25 (0.16)	-0.84 (0.15)

Placebo Tablet vs Linagliptin 5 mg Tablet: Least Squares Mean Difference: -0.58 (95% CI -0.91 to -0.26), p = 0.0005, ANCOVA

Population analysed: Full Analysis Set (FAS) includes all randomized patients who received study medication and had both a baseline HbA1c value and an on-treatment HbA1c value. Four subjects in each arm excluded for site non-compliance.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 weeks (from day of first dose until 7 days after last dose). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Tablet	2 of 120 (1.7%)	15 of 120 (12.5%)	Not reported
Linagliptin 5 mg Tablet	1 of 106 (0.9%)	9 of 106 (8.5%)	Not reported

Limitations and caveats (from the sponsor): Eight randomized subjects were excluded from all analysis due to overall data integrity issues at the site

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25236917Lajara R, Aguilar R, Hehnke U, Woerle HJ, von Eynatten M. Efficacy and safety of linagliptin in subjects with long-standing type 2 diabetes mellitus (>10 years): evidence from pooled data of randomized, double-blind, placebo-controlled, phase III trials. Clin Ther. 2014 Nov 1;36(11):1595-605. doi: 10.1016/j.clinthera.2014.07.020. Epub 2014 Sep 16.
Derived from this study: PubMed 23134211Thrasher J, Daniels K, Patel S, Whetteckey J. Black/African American patients with type 2 diabetes mellitus: study design and baseline patient characteristics from a randomized clinical trial of linagliptin. Expert Opin Pharmacother. 2012 Dec;13(17):2443-52. doi: 10.1517/14656566.2012.740459. Epub 2012 Nov 8.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

93 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 93 sites in United States.

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 7 inclusion and 18 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States. 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 26 Oct 2012). 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 (Glycosylated Hemoglobin) After 24 Weeks (time frame: baseline, 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01194830, 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 29 Jan 2014.