Diabetes Mellitus, Type 2Phase 1NCT01408888
A Study of LY2189265 and Sitagliptin in Participants With Type 2 Diabetes
A Phase 1 study testing LY2189265 and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
The purpose of this study is to study the effect of LY2189265 on how the body absorbs and processes a Type 2 Diabetes Mellitus (T2DM) drug (sitagliptin) and how sitagliptin affects LY2189265 when they are taken together. The duration of participation in this study is expected to be approximately 61 days. 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?
- LY2189265 and Sitagliptin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2011to Apr 2012
- Phase
- Phase 1
- 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
- are males or females, diagnosed with T2DM (Type 2 Diabetes Mellitus) for ≥3 months prior to screening
- male participants with female partners of child-bearing potential, or partners who are pregnant or breastfeeding, agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator. The method may be one of the following:
- condom with spermicidal agent
- male participant sterilization
- true abstinence (which is in line with the participant's usual lifestyle choice; withdrawal or calendar methods are not considered acceptable)
- female participants not of child-bearing potential (that is, are postmenopausal or permanently sterilized [such as, tubal occlusion, hysterectomy, bilateral salpingectomy]). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrollment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) or at least 1 year of spontaneous amenorrhea, with follicle stimulating hormone (FSH) ≥40 milli-international units/milliliter (mIU/mL)
Show all 15Show fewer
- female participants who have undergone sterilization by tubal ligation: agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such participants must also test negative for pregnancy at the time of enrollment
- have a body mass index (BMI) of between 23.0 and 40.0 kilograms/meter squared (kg/m^2), inclusive, at the time of screening
- have T2DM controlled with diet and exercise alone, or are on a stable dose of metformin Immediate Release (IR) for at least 4 weeks prior to screening, or are on metformin Extended Release (ER) and are capable/willing to be switched onto metformin IR or washed out prior to the first dose of investigational product, or are on sulfonylureas, acarbose (or other disaccharidase inhibitors), thiazolidinediones, or meglitinides and are capable/willing to be washed out prior to the first dose of investigational product
- have a fasting blood glucose value at screening ≤15.3 millimoles/liter (mmol/L) (275 milligrams/deciliter [mg/dL])
- have a glycosylated hemoglobin A1c (HbA1c) value at screening (or within 4 weeks prior to screening) of 6.5% to 10%
- have clinical laboratory test results within normal reference range for the population or within normal reference range for the investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable.
- have creatinine clearance (CrCl) of greater than 50 milliliters/minute (mL/min) at screening estimated by the Cockcroft-Gault formula
- have venous access sufficient to allow for blood sampling as per the protocol
- are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Who cannot join
- are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- have known allergies to glucagon-like-peptide 1 (GLP-1)-related compounds, including LY2189265 or to sitagliptin-related compounds or any components of either formulation
- are persons who have previously completed or withdrawn from this study or any other study investigating LY2189265 in the 3 months prior to screening or have received glucagon-like peptides or incretin mimetics in the 3 months prior to screening
- have taken insulin, chlorpropamide, or alpha-glucosidase inhibitors within 30 days prior to screening
- have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
- have poorly controlled hypertension (systolic blood pressure [BP] >160 millimeters of mercury [mmHg] and/or diastolic BP >100 mmHg) and/or evidence of labile BP including symptomatic postural hypotension
Show all 23Show fewer
- have a history or presence of respiratory, hepatic, renal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- have a history or presence of cardiovascular disorder (including myocardial infarction, cerebrovascular accident, venous thromboembolism, arrhythmia [judged by the investigator to be clinically significant], or angina) within the last year, have symptoms or signs of congestive heart failure, or are expected to require coronary artery bypass surgery or angioplasty
- have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or gastrointestinal disorder, for example relevant esophageal reflux or gall bladder disease, or any gastrointestinal disease which impacts gastric emptying (GE) (such as, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs or dipeptidyl peptidase-4 (DPP-4) inhibitors. Participants with dyslipidemia, and participants who had cholecystolithiasis (removal of gall stones) and/or cholecystectomy (removal of gall bladder) in the past, with no further sequelae, may be included in the study at the discretion of the screening physician
- have any existing medical condition that might interfere with interpretation of the data, including a history of gastrointestinal surgery (with the exception of appendectomy performed more than 12 months ago), peptic ulceration, gastrointestinal bleeding, diabetic gastroparesis, ulcerative colitis, Crohn's disease, Irritable Bowel Syndrome (IBS), gastric bypass, or laparoscopic gastric banding
- show evidence of significant active neuropsychiatric disease
- have had 2 or more episodes of severe hypoglycemia within the last 6 months prior to screening
- have personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
- regularly uses known drugs of abuse and/or show positive findings on urinary drug screening
- intend to start new concomitant medication during the study, including over-the-counter and herbal medication, regularly use drugs that directly reduce gastrointestinal motility and/or regularly use systemic corticosteroids by oral, intravenous, or intramuscular route, or potent, inhaled, or intranasal steroids known to have a high rate of systemic absorption
- show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- show evidence of hepatitis C and/or positive hepatitis C antibody
- show evidence of hepatitis B and/or positive hepatitis B surface antigen
- have donated blood of more than 500 milliliters (mL) within the last month prior to screening
- have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption from Day -3 of each period until after the last pharmacokinetic (PK) sample has been taken for that period, or to limit alcohol intake to a maximum of 2 units/day on all other days from screening through to follow-up. (1 unit = 12 ounces [oz] or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
- smoke more than 10 cigarettes (or equivalent in nicotine) per day, and are unwilling to refrain from smoking on the day of LY2189265/sitagliptin administration or are unable to abide by Clinical Research Unit (CRU) restrictions on other inpatient days
- are participants who, in the opinion of the investigator, are in any way unsuitable to participate in the study
- have any medical conditions, medical history or are taking any medication which are contraindicated
Trial locations and contacts
3 sites in 1 country.
United States3 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dallas, Texas, 75247
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Daytona Beach, Florida, 32117
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Honolulu, Hawaii, 96814
About this study
Official title: Study to Evaluate the Effect of LY2189265 on Sitagliptin Pharmacokinetics in Patients With Type 2 Diabetes Mellitus
The purpose of this study is to study the effect of LY2189265 on how the body absorbs and processes a Type 2 Diabetes Mellitus (T2DM) drug (sitagliptin) and how sitagliptin affects LY2189265 when they are taken together.
The duration of participation in this study is expected to be approximately 61 days. The study requires 2 clinic confinements (one of 2 nights and one of 19 nights duration).
The study involves 3 injections, subcutaneous, of 1.5 milligrams (mg) LY2189265 and 18 daily doses of 100 mg sitagliptin tablets administered orally.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2189265, 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.
LY2189265Biological
Also called Dulaglutide
Administered subcutaneously
SitagliptinDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY2189265, Sitagliptin + LY2189265 | Experimental | A single 1.5-milligram (mg) dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Receives: Biological: LY2189265; Drug: Sitagliptin |
| Sitagliptin + LY2189265, LY2189265 | Experimental | 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). There was a washout of at least 21 days before crossing over and receiving a single 1.5 mg dose of LY2189265 administered subcutaneously (Treatment 1). Receives: Biological: LY2189265; Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin
Area under the sitagliptin pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (24 hours) is summarized.
Measured: Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Sitagliptin
Measured: Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2
Secondary outcomes (4)
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Sitagliptin
Measured: Predose and up to 24 hours post dose on Day 4, Day 6, and Day 13 of Treatment 2
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2189265
Area under the LY2189265 pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (168 hours) is summarized.
Measured: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2189265
Measured: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2189265
Measured: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2012
- Study completionApr 2012
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.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408888
- Sponsor's protocol ID
- 14361
- Other IDs
- H9X-MC-GBDW
- Status last verified
- Oct 2014
- First submitted
- 2 Aug 2011
- Last updated
- 7 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Effect of LY2189265 on Sitagliptin Pharmacokinetics in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01408888
- Acronym / sponsor ID
- 14361
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Posted 7 Oct 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 study is to study the effect of LY2189265 on how the body absorbs and processes a Type 2 Diabetes Mellitus (T2DM) drug (sitagliptin) and how sitagliptin affects LY2189265 when they are taken together.
The duration of participation in this study is expected to be approximately 61 days. The study requires 2 clinic confinements (one of 2 nights and one of 19 nights duration).
The study involves 3 injections, subcutaneous, of 1.5 milligrams (mg) LY2189265 and 18 daily doses of 100 mg sitagliptin tablets administered orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY2189265, Sitagliptin + LY2189265 | Experimental | Biological: LY2189265, Drug: SitagliptinA single 1.5-milligram (mg) dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). |
| Sitagliptin + LY2189265, LY2189265 | Experimental | Biological: LY2189265, Drug: Sitagliptin100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). There was a washout of at least 21 days before crossing over and receiving a single 1.5 mg dose of LY2189265 administered subcutaneously (Treatment 1). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- are males or females, diagnosed with T2DM (Type 2 Diabetes Mellitus) for ≥3 months prior to screening
- male participants with female partners of child-bearing potential, or partners who are pregnant or breastfeeding, agree to use a reliable method of contraception from the time of the first dose until 3 months after the last dose of investigational product, as determined by the investigator. The method may be one of the following:
- female participants not of child-bearing potential (that is, are postmenopausal or permanently sterilized [such as, tubal occlusion, hysterectomy, bilateral salpingectomy]). Such participants will not be required to use contraception but must test negative for pregnancy at the time of enrollment. Postmenopausal is defined as at least 1 year post cessation of menses (without an alternative medical cause) or at least 1 year of spontaneous amenorrhea, with follicle stimulating hormone (FSH) ≥40 milli-international units/milliliter (mIU/mL)
- female participants who have undergone sterilization by tubal ligation: agree to use a condom in conjunction with spermicidal gel, foam, cream, film or suppository from the time of screening until 3 months after the last dose of investigational product. Such participants must also test negative for pregnancy at the time of enrollment
- have a body mass index (BMI) of between 23.0 and 40.0 kilograms/meter squared (kg/m^2), inclusive, at the time of screening
Key exclusion criteria (23 listed)
- are currently enrolled in, have completed or discontinued within the last 30 days from, a clinical trial involving an investigational product, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- have known allergies to glucagon-like-peptide 1 (GLP-1)-related compounds, including LY2189265 or to sitagliptin-related compounds or any components of either formulation
- are persons who have previously completed or withdrawn from this study or any other study investigating LY2189265 in the 3 months prior to screening or have received glucagon-like peptides or incretin mimetics in the 3 months prior to screening
- have taken insulin, chlorpropamide, or alpha-glucosidase inhibitors within 30 days prior to screening
- have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
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 |
|---|---|---|
| LY2189265Also: DulaglutideAdministered subcutaneously | Biological | LY2189265, Sitagliptin + LY2189265, Sitagliptin + LY2189265, LY2189265 |
| SitagliptinAdministered orally | Drug | LY2189265, Sitagliptin + LY2189265, Sitagliptin + LY2189265, LY2189265 |
Primary outcome
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin
Time frame: Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2
Area under the sitagliptin pharmacokinetic (PK) concentration versus time curve (AUC [0-tau]) during one dosing interval (24 hours) is summarized.
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of Sitagliptin
Time frame: Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2
4 secondary outcomes
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Sitagliptin
Time frame: Predose and up to 24 hours post dose on Day 4, Day 6, and Day 13 of Treatment 2
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY2189265
Time frame: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2
Pharmacokinetics: Maximum Observed Drug Concentration (Cmax) of LY2189265
Time frame: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2
Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of LY2189265
Time frame: Predose and up to 168 hours postdose on Day 1 of Treatment 1 and on Day 5 and Day 12 of Treatment 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetes Mellitus, Type 2
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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2189265 and Sitagliptin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 3 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 15 inclusion and 23 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 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 7 Oct 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?
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of Sitagliptin (time frame: Predose and up to 24 hours postdose on Day 4, Day 6, and Day 13 of Treatment 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2014.