Diabetes Mellitus, Type 2Phase 4NCT01512979
Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes
A Phase 4 study testing metformin and linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 82 sites in 12 countries.
Trial summary
The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- metformin and linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 316 participants
- Where
- 82 sitesin 12 countries
- Study dates
- Jan 2012to Apr 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation / Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial.
- Male and female patients, 18 years of age or older at Visit 1 (Screen), with newly diagnosed (less than 12 months prior to Screen) Type 2 Diabetes Mellitus.
- Patients who are treatment-naïve, defined as absence of any oral antidiabetic therapy, injectable glucagon-like peptide-1 agonist/analogue, or insulin, and uncontrolled for the 12 weeks prior to randomisation.
- Patients must have an glycated (or glycosylated) haemoglobin (HbA1c) between 8.5% [69 millimoles per mole (mmol/mol)] and 12.0% (108 mmol/mol) at Visit 1 (Screen).
- Patients must have a Body Mass Index (BMI) of 45 kg/m2 or less at Visit 1 (Screen).
- In the investigators opinion, patients must be reliable, honest, compliant, and agree to cooperate with all planned future trial evaluations as explained in detail during the informed consent process and to be able to perform them.
Who cannot join
- Patients with, who are, who have, or who have had:
- Acute coronary syndrome (non-ST Elevation Myocardial Infarction (STEMI), STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent.
- Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal (ULN) in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase. Gilbert-Meulengracht syndrome (also known as conjugated hyperbilirubinemia, constitutional hepatic dysfunction, or familial nonhemolytic jaundice) will be permitted.
- Impaired renal function, defined as calculated creatinine clearance of less than 60 milliliters per minute (< 60 mL/min), by the Cockcroft-Gault Equation, as determined during Screen and/or Run-In Period.
- Bariatric, gastric bypass, and other gastrointestinal surgeries (including all types of gastric banding and/or LapBand) within the past two years.
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
Show all 17Show fewer
- Medical history of pancreatitis.
- Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, haemolytic anaemia).
- Any contraindication to metformin and/or linagliptin therapies, according to local labels.
- Treatment with anti-obesity drugs, including over-the-counter drugs such as Alli (orlistat), 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight.
- Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except Type 2 Diabetes Mellitus.
- Pre-menopausal women (last menstruation of 1 year or less prior to informed consent) who are nursing or pregnant, 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 trial and do not agree to submit to periodic pregnancy testing during participation in the trial.
- Note: Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems, oral, implantable, intra-vaginal, or injectable contraceptives, Essure micro-inserts placed more than six months prior to Screen Visit, complete sexual abstinence (if acceptable by local authorities), double barrier method (e.g., diaphragm or condom and spermicide), and vasectomised partner.
- Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance to trial procedures or study medication intake in the opinion of the investigator.
- Participation in another trial with an investigational drug within 2 months prior to informed consent.
- Any other clinical condition that would jeopardize patient safety while participating in this clinical trial in the opinion of the Investigator.
- Inability to commit to regular overnight fasting of at least 10 hours duration and attendance to study site visits between 07:00 and 11:00 ante meridiem (a.m.).
Trial locations and contacts
82 sites in 12 countries.
82 sites in 12 countries
United States29 sites
1218.83.11004 Boehringer Ingelheim Investigational Site
Bristol, Tennessee
1218.83.11017 Boehringer Ingelheim Investigational Site
Chattanooga, Tennessee
1218.83.11011 Boehringer Ingelheim Investigational Site
Chino, California
1218.83.11018 Boehringer Ingelheim Investigational Site
Columbia, South Carolina
1218.83.11005 Boehringer Ingelheim Investigational Site
Edison, New Jersey
1218.83.11008 Boehringer Ingelheim Investigational Site
Elkton, Maryland
1218.83.11022 Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
1218.83.11003 Boehringer Ingelheim Investigational Site
Franklin, Ohio
1218.83.11027 Boehringer Ingelheim Investigational Site
Freemont, Nebraska
1218.83.11024 Boehringer Ingelheim Investigational Site
Gallipolis, Ohio
1218.83.11032 Boehringer Ingelheim Investigational Site
Grand Prairie, Texas
1218.83.11030 Boehringer Ingelheim Investigational Site
Houston, Texas
1218.83.11001 Boehringer Ingelheim Investigational Site
Huntington Beach, California
1218.83.11019 Boehringer Ingelheim Investigational Site
Huntington Park, California
1218.83.11013 Boehringer Ingelheim Investigational Site
Jacksonville, North Carolina
1218.83.11036 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
1218.83.11015 Boehringer Ingelheim Investigational Site
Lomita, California
1218.83.11023 Boehringer Ingelheim Investigational Site
Norwalk, California
1218.83.11029 Boehringer Ingelheim Investigational Site
Oakwood, Georgia
1218.83.11025 Boehringer Ingelheim Investigational Site
Orlando, Florida
1218.83.11026 Boehringer Ingelheim Investigational Site
Owensboro, Kentucky
1218.83.11002 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1218.83.11014 Boehringer Ingelheim Investigational Site
Roseville, California
1218.83.11028 Boehringer Ingelheim Investigational Site
Salisbury, North Carolina
1218.83.11034 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1218.83.11031 Boehringer Ingelheim Investigational Site
San Diego, California
1218.83.11033 Boehringer Ingelheim Investigational Site
Sanford, Florida
1218.83.11009 Boehringer Ingelheim Investigational Site
Shelby, North Carolina
1218.83.11021 Boehringer Ingelheim Investigational Site
Tomball, Texas
Canada10 sites
1218.83.12011 Boehringer Ingelheim Investigational Site
Calgary, Alberta
1218.83.12007 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1218.83.12010 Boehringer Ingelheim Investigational Site
Greater Sudbury, Ontario
1218.83.12005 Boehringer Ingelheim Investigational Site
Kitchener, Ontario
1218.83.12006 Boehringer Ingelheim Investigational Site
London, Ontario
1218.83.12002 Boehringer Ingelheim Investigational Site
Paradise, Newfoundland and Labrador
1218.83.12001 Boehringer Ingelheim Investigational Site
Red Deer, Alberta
1218.83.12003 Boehringer Ingelheim Investigational Site
Smiths Falls, Ontario
1218.83.12009 Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
1218.83.12012 Boehringer Ingelheim Investigational Site
Winnipeg, Ontario
Philippines7 sites
1218.83.63001 Boehringer Ingelheim Investigational Site
Cebu
1218.83.63007 Boehringer Ingelheim Investigational Site
Cebu City
1218.83.63003 Boehringer Ingelheim Investigational Site
Iloilo City
1218.83.63008 Boehringer Ingelheim Investigational Site
Iloilo City
1218.83.63002 Boehringer Ingelheim Investigational Site
Marikina City
1218.83.63006 Boehringer Ingelheim Investigational Site
Marikina City
1218.83.63004 Boehringer Ingelheim Investigational Site
Quezon
Russia7 sites
1218.83.07001 Boehringer Ingelheim Investigational Site
Kazan'
1218.83.07002 Boehringer Ingelheim Investigational Site
Petrozavodsk
1218.83.07003 Boehringer Ingelheim Investigational Site
Saint Petersburg
1218.83.07007 Boehringer Ingelheim Investigational Site
Saint Petersburg
1218.83.07004 Boehringer Ingelheim Investigational Site
Samara
1218.83.07006 Boehringer Ingelheim Investigational Site
Smolensk
1218.83.07005 Boehringer Ingelheim Investigational Site
Yaroslavl
Ukraine7 sites
1218.83.38007 Boehringer Ingelheim Investigational Site
Dnipro
1218.83.38001 Boehringer Ingelheim Investigational Site
Ivano-Frankivsk
1218.83.38006 Boehringer Ingelheim Investigational Site
Kharkiv
1218.83.38004 Boehringer Ingelheim Investigational Site
Odesa
1218.83.38008 Boehringer Ingelheim Investigational Site
Vinnitsa
1218.83.38003 Boehringer Ingelheim Investigational Site
Vinnytsia
1218.83.38005 Boehringer Ingelheim Investigational Site
Vinnytsia
Mexico5 sites
1218.83.52004 Boehringer Ingelheim Investigational Site
Cuautla
1218.83.52001 Boehringer Ingelheim Investigational Site
Guadalajara
1218.83.52002 Boehringer Ingelheim Investigational Site
Guadalajara
1218.83.52005 Boehringer Ingelheim Investigational Site
Mérida
1218.83.52003 Boehringer Ingelheim Investigational Site
Tampico
Sri Lanka4 sites
1218.83.94004 Boehringer Ingelheim Investigational Site
Dehiwala
1218.83.94002 Boehringer Ingelheim Investigational Site
Galle, Sri Lanka
1218.83.94003 Boehringer Ingelheim Investigational Site
Kandy
1218.83.94001 Boehringer Ingelheim Investigational Site
Ragama
India3 sites
1218.83.91003 Boehringer Ingelheim Investigational Site
Bangalore
1218.83.91005 Boehringer Ingelheim Investigational Site
Chennai
1218.83.91001 Boehringer Ingelheim Investigational Site
Mumbai
Israel3 sites
1218.83.97004 Boehringer Ingelheim Investigational Site
Haifa
1218.83.97005 Boehringer Ingelheim Investigational Site
Haifa
1218.83.97007 Boehringer Ingelheim Investigational Site
Holon
Malaysia3 sites
1218.83.60001 Boehringer Ingelheim Investigational Site
Kelantan
1218.83.60002 Boehringer Ingelheim Investigational Site
Perak
1218.83.60003 Boehringer Ingelheim Investigational Site
Selangor, Malaysia
Thailand3 sites
1218.83.66002 Boehringer Ingelheim Investigational Site
Bangkok
1218.83.66003 Boehringer Ingelheim Investigational Site
Bangkok
1218.83.66001 Boehringer Ingelheim Investigational Site
Muang, Khonkaen
Puerto Rico1 site
1218.83.11037 Boehringer Ingelheim Investigational Site
San Juan
About this study
Official title: A 24-week, Randomized, Double-blind, Active-controlled, Parallel Group Trial to Assess the Superiority of Oral Linagliptin and Metformin Compared to Linagliptin Monotherapy in Newly Diagnosed, Treatment-naïve, Uncontrolled Type 2 Diabetes Mellitus Patients
The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- metformin, linagliptin, metformin 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.
metforminDrug
1000 mg to 2000 mg per day
linagliptinDrug
5 mg daily
metformin placeboDrug
0 to 2 tablets daily
metformin placeboDrug
4 tablets daily
| Study group | Role | What they receive |
|---|---|---|
| linagliptin | Experimental | patients receive linagliptin tablet once daily Receives: Drug: linagliptin; Drug: metformin placebo |
| linagliptin plus metformin | Experimental | patients receive linagliptin tablet once daily and metformin tablets twice daily Receives: Drug: metformin; Drug: linagliptin; Drug: metformin placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c After 24 Weeks
HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c
Measured: Baseline and 24 weeks
Secondary outcomes (6)
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment
The change from baseline is the FPG after 24 weeks minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c and continuous baseline fasting plasma glucose.
Measured: Baseline and 24 weeks
Change From Baseline in HbA1c by Visit Over Time
HbA1c is measured as a percentage. The change from baseline is the HbA1c over time minus the baseline HbA1c. The model includes treatment, continuous baseline HbA1c in addition to week repeated within patient, week by baseline HbA1c interaction and week by treatment interaction.
Measured: Baseline, 6, 12, 18 and 24 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)
The proportion of patients who achieved HbA1c lowering by at least 0.5% after 24 weeks of treatment.The model includes treatment, and continuous baseline HbA1c.
Measured: Baseline and 24 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)
The proportion of patients who achieved HbA1c lowering by at least 1.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.
Measured: Baseline and 24 weeks
Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment
The proportion of patients who achieved HbA1c below 7.0% after 24 weeks of treatment. The model includes treatment, and continuous baseline HbA1c.
Measured: Baseline and 24 weeks
Change From Baseline in FPG by Visit Over Time
The change from baseline is the FPG over time minus the baseline FPG. Means are adjusted for treatment, continuous baseline HbA1c, continuous baseline FPG in addition to week repeated within patient, week by baseline FPG interaction and week by treatment interaction.
Measured: Baseline, 6, 12, 18 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionApr 2013
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512979
- Sponsor's protocol ID
- 1218.83
- Other IDs
- 2011-004158-24
- Status last verified
- May 2014
- First submitted
- 16 Jan 2012
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ross SA, Caballero AE, Del Prato S, Gallwitz B, Lewis-D'Agostino D, Bailes Z, Thiemann S, Patel S, Woerle HJ, von Eynatten M. Linagliptin plus metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycemia. Postgrad Med. 2016 Nov;128(8):747-754. doi: 10.1080/00325481.2016.1238280. Epub 2016 Sep 29.
PubMed 27684308
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week, Randomized, Double-blind, Active-controlled, Parallel Group Trial to Assess the Superiority of Oral Linagliptin and Metformin Compared to Linagliptin Monotherapy in Newly Diagnosed, Treatment-naïve, Uncontrolled Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT01512979
- Acronym / sponsor ID
- 1218.83
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 20 Jan 2012 (estimated)
- Results
- Posted 9 May 2014
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 trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| linagliptin | Experimental | Drug: linagliptin, Drug: metformin placebopatients receive linagliptin tablet once daily |
| linagliptin plus metformin | Experimental | Drug: metformin, Drug: linagliptin, Drug: metformin placebopatients receive linagliptin tablet once daily and metformin tablets twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must sign and date an Informed Consent consistent with International Conference on Harmonisation / Good Clinical Practice guidelines and local regulations prior to any evaluation and participation in the trial.
- Male and female patients, 18 years of age or older at Visit 1 (Screen), with newly diagnosed (less than 12 months prior to Screen) Type 2 Diabetes Mellitus.
- Patients who are treatment-naïve, defined as absence of any oral antidiabetic therapy, injectable glucagon-like peptide-1 agonist/analogue, or insulin, and uncontrolled for the 12 weeks prior to randomisation.
- Patients must have an glycated (or glycosylated) haemoglobin (HbA1c) between 8.5% [69 millimoles per mole (mmol/mol)] and 12.0% (108 mmol/mol) at Visit 1 (Screen).
- Patients must have a Body Mass Index (BMI) of 45 kg/m2 or less at Visit 1 (Screen).
Key exclusion criteria (17 listed)
- Acute coronary syndrome (non-ST Elevation Myocardial Infarction (STEMI), STEMI, and unstable angina pectoris), stroke or transient ischemic attack within 3 months prior to informed consent.
- Indication of liver disease determined during Screen and/or Run-In Period, defined by a serum level above 3 times the upper limit of normal (ULN) in any of the following: alanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase. Gilbert-Meulengracht syndrome (also known as conjugated hyperbilirubinemia, constitutional hepatic dysfunction, or familial nonhemolytic jaundice) will be permitted.
- Impaired renal function, defined as calculated creatinine clearance of less than 60 milliliters per minute (< 60 mL/min), by the Cockcroft-Gault Equation, as determined during Screen and/or Run-In Period.
- Bariatric, gastric bypass, and other gastrointestinal surgeries (including all types of gastric banding and/or LapBand) within the past two years.
- Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
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 |
|---|---|---|
| metformin1000 mg to 2000 mg per day | Drug | linagliptin plus metformin |
| linagliptin5 mg daily | Drug | linagliptin, linagliptin plus metformin |
| metformin placebo0 to 2 tablets daily | Drug | linagliptin plus metformin |
| metformin placebo4 tablets daily | Drug | linagliptin |
Primary outcome
Change From Baseline in HbA1c After 24 Weeks
Time frame: Baseline and 24 weeks
HbA1c is measured as a percentage. The change from baseline is the Week 24 HbA1c minus the baseline HbA1c. Means are adjusted for treatment and continuous baseline HbA1c
6 secondary outcomes
Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks of Treatment
Time frame: Baseline and 24 weeks
Change From Baseline in HbA1c by Visit Over Time
Time frame: Baseline, 6, 12, 18 and 24 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 0.5% After 24 Weeks of Treatment)
Time frame: Baseline and 24 weeks
Occurrence of Relative Efficacy Response (HbA1c Lowering by at Least 1.0% After 24 Weeks of Treatment)
Time frame: Baseline and 24 weeks
Occurrence of Treat to Target Efficacy Response (HbA1c <7.0%) After 24 Weeks of Treatment
Time frame: Baseline and 24 weeks
Change From Baseline in FPG by Visit Over Time
Time frame: Baseline, 6, 12, 18 and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27684308Ross SA, Caballero AE, Del Prato S, Gallwitz B, Lewis-D'Agostino D, Bailes Z, Thiemann S, Patel S, Woerle HJ, von Eynatten M. Linagliptin plus metformin in patients with newly diagnosed type 2 diabetes and marked hyperglycemia. Postgrad Med. 2016 Nov;128(8):747-754. doi: 10.1080/00325481.2016.1238280. Epub 2016 Sep 29.
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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
82 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing metformin and linagliptin in people with Diabetes Mellitus, Type 2, run by Boehringer Ingelheim at 82 sites in 12 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 6 inclusion and 17 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in United States, Canada, Philippines, Russia, Ukraine and 7 more countries. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 9 May 2014). 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 After 24 Weeks (time frame: Baseline and 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 NCT01512979, 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 20 May 2014.