Diabetes Mellitus, Type 2Phase 1NCT02660736
Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
A Phase 1 study testing Albiglutide Liquid Auto-injector and Albiglutide Lyophilized DCC Pen Injector in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
Trial summary
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen injector, requiring reconstitution prior to use. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Albiglutide Liquid Auto-injector and Albiglutide Lyophilized DCC Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18 and 65 years of age.
- Healthy.
- Subject is a nonsmoker.
- Subject's body mass index (BMI) is >=18 kilogram/meter square (kg/m^2) and <=30 kg/m^2
- Male or
- Female
Who cannot join
- Alanine aminotransferase (ALT) >1.5 x upper limit of normal range (ULN)
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 millisecond (msec).
- Systolic blood pressure is >=140 millimeter of mercury (mmHg) at Screening;
- Diastolic blood pressure is >=90 mmHg at Screening;
Show all 26Show fewer
- Heart rate is >100 beats/min at Screening.
- estimated glomerular filtration rate (eGFR) <=80 milliliter per minute per 1.73 meter square (mL/min/1.73 m^2) (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) at Screening.
- Fasting triglyceride level >300 milligram per deciliter (mg/dL) at Screening.
- History of significant cardiovascular or pulmonary dysfunction prior to Screening.
- History of thyroid dysfunction or an abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at Screening.
- History of gastrointestinal surgery that could influence gastric emptying (e.g., gastrectomy, gastric bypass).
- History of pancreatitis.
- Personal or family history of multiple endocrine neoplasia type 2.
- Personal or family history of medullary carcinoma of the thyroid.
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days.
- History of regular alcohol consumption within 6 months of the study.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 3 months prior to screening.
- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy.
- Subject has previously received any GLP-1 mimetic compound (eg., exenatide, liraglutide, lixisenatide, dulaglutide).
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Subject has donated blood in excess of 500 mL within 56 days prior to dosing or intention of donating in the month after completing the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Single-dose, Crossover Study to Compare Two Albiglutide Drug Products for Bioequivalence in Healthy Adult Subjects
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will enable the use of a liquid product in a ready-to-use single dose auto-injector. To support the development of the liquid auto-injector product, this healthy volunteer bioequivalence study will be conducted to compare the liquid drug product to the currently available lyophilized product. This is Phase I, randomized, double-blind, double dummy, single-dose, 2-period crossover study in healthy volunteers. This study will compare the pharmacokinetics and safety of the albiglutide 50 mg liquid drug product with the albiglutide 50 mg commercial lyophilized drug product.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Albiglutide Liquid Auto-injector, Albiglutide Lyophilized DCC Pen Injector, Placebo Liquid Auto-injector, Placebo Lyophilized DCC Pen injector
- Keywords
- Albiglutide, Randomized, Pharmacokinetics, GSK716155, Bioequivalence study
- 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.
Albiglutide Liquid Auto-injectorDrug
Albiglutide liquid is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid (50 mg). The auto-injector delivers the study treatment in an injection volume of 1.0 mL for the 50 mg dose
Albiglutide Lyophilized DCC Pen InjectorDrug
Albiglutide is supplied as prefilled DCC Pen Injector. Each DCC contains lyophilized albiglutide 50 mg. When the injector pen product is reconstituted a neutral, isotonic solution is produced. The pen delivers albiglutide in an injection volume of 0.5 mL
Placebo Liquid Auto-injectorDrug
Liquid albiglutide matching placebo is provided as a fixed-dose, disposable autoinjector containing placebo liquid. The auto-injector delivers the placebo in an injection volume of 1.0 mL for the 50 mg placebo dose.
Placebo Lyophilized DCC Pen injectorDrug
Placebo is supplied as prefilled DCC Pen Injector. Each DCC contains matching placebo. When the injector pen product is reconstituted a neutral, isotonic placebo solution is produced. The pen delivers the placebo in an injection volume of 0.5 mL.
| Study group | Role | What they receive |
|---|---|---|
| Regimen AB | Experimental | Subjects will be receive Regimen A treatment in Session 1 followed by Regimen B treatment in Session 2.
Regimen A: 50 mg Albiglutide Liquid Auto-injector + Placebo lyophilized DCC Pen injector.
Regimen B: 50 mg Albiglutide lyophilized DCC Pen injector + Placebo Liquid Auto-injector.
A minimum of an 8-week washout period between study treatment administration of Session 1 and Session 2. Receives: Drug: Albiglutide Liquid Auto-injector; Drug: Albiglutide Lyophilized DCC Pen Injector; Drug: Placebo Liquid Auto-injector; Drug: Placebo Lyophilized DCC Pen injector |
| Regimen BA | Experimental | Subjects will be receive Regimen B treatment in Session 1 followed by Regimen A treatment in Session 2.
Regimen A: 50 mg Albiglutide Liquid Auto-injector + Placebo lyophilized DCC Pen injector.
Regimen B: 50 mg Albiglutide lyophilized DCC Pen injector + Placebo Liquid Auto-injector.
A minimum of an 8-week washout period between study treatment administration of Session 1 and Session 2. Receives: Drug: Albiglutide Liquid Auto-injector; Drug: Albiglutide Lyophilized DCC Pen Injector; Drug: Placebo Liquid Auto-injector; Drug: Placebo Lyophilized DCC Pen injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) from 0 to the last measurable concentration (AUC 0-t) for albiglutide in session 1 and 2
PK blood samples will be collected for determination of albiglutide plasma concentrations and (AUC 0-t).
Measured: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
AUC from 0 to infinity (AUC [0-inf]) for albiglutide in session 1 and 2
PK blood samples will be collected for determination of albiglutide plasma concentrations AUC(0-inf).
Measured: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Peak plasma concentration (Cmax) for albiglutide in session 1 and 2
PK blood samples will be collected for determination of albiglutide Cmax.
Measured: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Secondary outcomes (11)
Time to maximal concentration (Tmax) for albiglutide in session 1 and 2
PK blood samples will be collected for determination of albiglutide Tmax.
Measured: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Clearance (CL/F) for albiglutide in session 1 and 2.
PK blood samples will be collected for determination of albiglutide CL/F
Measured: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Volume of distribution (V/F) for albiglutide in session 1 and 2
PK blood samples will be collected for determination of albiglutide V/F
Measured: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Number of subjects with adverse events (AE) and clinical observations as a measure of safety and tolerability
AE will be collected during the study. Intensity of AE will be captured
Measured: Up to 21 weeks
Safety as assessed by 12-lead electrocardiogram (ECG)
Single 12-lead ECGs will be obtained at the specified time points during the study using an ECG machine that automatically calculates the heart rate and other measures.
Measured: Screening, Day -1, Day 4, and Day 35 in both sessions 1 and 2
Safety as assessed by systolic, diastolic blood pressure, and pulse rate measurements
Systolic and diastolic pressure and pulse rate will be measured at specified time point
Measured: Up to 21 weeks
Immunogenicity as assessed by enzyme-linked immunosorbent assay (ELISA) and hypersensitivity reactions.
Immunogenicity serum samples will be collected at specified time points to assess the presence of anti-drug antibodies through enzyme-linked immunosorbent assay (ELISA) method.
Measured: Day 1 in both sessions and Day 13 in session 1 and follow-up visit
Half-life (T1/2) for albiglutide in session 1 and 2
PK blood samples will be collected for determination of albiglutide T1/2.
Measured: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2.
Composite of hematology parameters as a measure of safety
The following hematology parameters will be measured: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, Reticulocyte count, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), MCH Concentration, white blood cell (WBC) count, neutrophils, lymphocytes, monocytes, eosinophils, and basophils.
Measured: Up to 21 weeks
Composite of clinical chemistry parameters as a measure of safety
The following clinical chemistry parameters will be measured: blood urea nitrogen (BUN), creatinine, fasting glucose, uric acid, thyroid-stimulating hormone (TSH), potassium, sodium, calcium, phosphorus, magnesium, aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase, gamma glutamyl transferase (GGT), chloride, total and direct bilirubin, total protein, albumin, total carbon dioxide, and fasting triglycerides.
Measured: Up to 21 weeks
Composite of urinalysis parameters as a measure of safety
The following urinalysis parameters will be measured: specific gravity, power of hydrogen (pH), glucose, protein, blood and ketones by dipstick; microscopic examination (if blood or protein is abnormal), microalbumin, creatinine, albumin/creatinine ratio, blood, leukocyte esterase, and nitrites.
Measured: Up to 21 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 GlaxoSmithKlineThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660736
- Sponsor's protocol ID
- 201287
- Status last verified
- Nov 2016
- First submitted
- 11 Jan 2016
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shaddinger BC, Vlasakakis G, Soffer J, Thorpe KM, Hatch D, Nino AJ. A Randomized, Double-Blind, Single-Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants. Clin Pharmacol Drug Dev. 2019 Apr;8(3):361-370. doi: 10.1002/cpdd.606. Epub 2018 Jul 31.
PubMed 30063297
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, Crossover Study to Compare Two Albiglutide Drug Products for Bioequivalence in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02660736
- Acronym / sponsor ID
- 201287
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Albiglutide, Randomized, Pharmacokinetics, GSK716155, Bioequivalence study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed and approved for the treatment of type 2 diabetes mellitus. Currently, lyophilized albiglutide and the diluent are provided in a dual chamber Cartridge (DCC) single-dose pen injector, requiring reconstitution prior to use. A liquid formulation of albiglutide will enable the use of a liquid product in a ready-to-use single dose auto-injector. To support the development of the liquid auto-injector product, this healthy volunteer bioequivalence study will be conducted to compare the liquid drug product to the currently available lyophilized product. This is Phase I, randomized, double-blind, double dummy, single-dose, 2-period crossover study in healthy volunteers. This study will compare the pharmacokinetics and safety of the albiglutide 50 mg liquid drug product with the albiglutide 50 mg commercial lyophilized drug product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regimen AB | Experimental | Drug: Albiglutide Liquid Auto-injector, Drug: Albiglutide Lyophilized DCC Pen Injector, Drug: Placebo Liquid Auto-injector, Drug: Placebo Lyophilized DCC Pen injectorSubjects will be receive Regimen A treatment in Session 1 followed by Regimen B treatment in Session 2. Regimen A: 50 mg Albiglutide Liquid Auto-injector + Placebo lyophilized DCC Pen injector. Regimen B: 50 mg Albiglutide lyophilized DCC Pen injector + Placebo Liquid Auto-injector. A minimum of an 8-week washout period between study treatment administration of Session 1 and Session 2. |
| Regimen BA | Experimental | Drug: Albiglutide Liquid Auto-injector, Drug: Albiglutide Lyophilized DCC Pen Injector, Drug: Placebo Liquid Auto-injector, Drug: Placebo Lyophilized DCC Pen injectorSubjects will be receive Regimen B treatment in Session 1 followed by Regimen A treatment in Session 2. Regimen A: 50 mg Albiglutide Liquid Auto-injector + Placebo lyophilized DCC Pen injector. Regimen B: 50 mg Albiglutide lyophilized DCC Pen injector + Placebo Liquid Auto-injector. A minimum of an 8-week washout period between study treatment administration of Session 1 and Session 2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 18 and 65 years of age.
- Healthy.
- Subject is a nonsmoker.
- Subject's body mass index (BMI) is >=18 kilogram/meter square (kg/m^2) and <=30 kg/m^2
- Male or
Key exclusion criteria (26 listed)
- Alanine aminotransferase (ALT) >1.5 x upper limit of normal range (ULN)
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent [%]).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) > 450 millisecond (msec).
- Systolic blood pressure is >=140 millimeter of mercury (mmHg) at Screening;
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 |
|---|---|---|
| Albiglutide Liquid Auto-injectorAlbiglutide liquid is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid (50 mg). The auto-injector delivers the study treatment in an injection volume of 1.0 mL for the 50 mg dose | Drug | Regimen AB, Regimen BA |
| Albiglutide Lyophilized DCC Pen InjectorAlbiglutide is supplied as prefilled DCC Pen Injector. Each DCC contains lyophilized albiglutide 50 mg. When the injector pen product is reconstituted a neutral, isotonic solution is produced. The pen delivers albiglutide in an injection volume of 0.5 mL | Drug | Regimen AB, Regimen BA |
| Placebo Liquid Auto-injectorLiquid albiglutide matching placebo is provided as a fixed-dose, disposable autoinjector containing placebo liquid. The auto-injector delivers the placebo in an injection volume of 1.0 mL for the 50 mg placebo dose. | Drug | Regimen AB, Regimen BA |
| Placebo Lyophilized DCC Pen injectorPlacebo is supplied as prefilled DCC Pen Injector. Each DCC contains matching placebo. When the injector pen product is reconstituted a neutral, isotonic placebo solution is produced. The pen delivers the placebo in an injection volume of 0.5 mL. | Drug | Regimen AB, Regimen BA |
Primary outcome
Area under the plasma concentration-time curve (AUC) from 0 to the last measurable concentration (AUC 0-t) for albiglutide in session 1 and 2
Time frame: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
PK blood samples will be collected for determination of albiglutide plasma concentrations and (AUC 0-t).
AUC from 0 to infinity (AUC [0-inf]) for albiglutide in session 1 and 2
Time frame: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
PK blood samples will be collected for determination of albiglutide plasma concentrations AUC(0-inf).
Peak plasma concentration (Cmax) for albiglutide in session 1 and 2
Time frame: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
PK blood samples will be collected for determination of albiglutide Cmax.
11 secondary outcomes
Time to maximal concentration (Tmax) for albiglutide in session 1 and 2
Time frame: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Clearance (CL/F) for albiglutide in session 1 and 2.
Time frame: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Volume of distribution (V/F) for albiglutide in session 1 and 2
Time frame: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2
Number of subjects with adverse events (AE) and clinical observations as a measure of safety and tolerability
Time frame: Up to 21 weeks
Safety as assessed by 12-lead electrocardiogram (ECG)
Time frame: Screening, Day -1, Day 4, and Day 35 in both sessions 1 and 2
Safety as assessed by systolic, diastolic blood pressure, and pulse rate measurements
Time frame: Up to 21 weeks
Immunogenicity as assessed by enzyme-linked immunosorbent assay (ELISA) and hypersensitivity reactions.
Time frame: Day 1 in both sessions and Day 13 in session 1 and follow-up visit
Half-life (T1/2) for albiglutide in session 1 and 2
Time frame: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2.
Composite of hematology parameters as a measure of safety
Time frame: Up to 21 weeks
Composite of clinical chemistry parameters as a measure of safety
Time frame: Up to 21 weeks
Composite of urinalysis parameters as a measure of safety
Time frame: Up to 21 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Derived from this study: PubMed 30063297Shaddinger BC, Vlasakakis G, Soffer J, Thorpe KM, Hatch D, Nino AJ. A Randomized, Double-Blind, Single-Dose, Crossover Study to Demonstrate the Bioequivalence of 2 Formulations of Albiglutide in Healthy Adult Participants. Clin Pharmacol Drug Dev. 2019 Apr;8(3):361-370. doi: 10.1002/cpdd.606. Epub 2018 Jul 31.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Albiglutide Liquid Auto-injector and Albiglutide Lyophilized DCC Pen Injector in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site 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 6 inclusion and 26 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 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the plasma concentration-time curve (AUC) from 0 to the last measurable concentration (AUC 0-t) for albiglutide in session 1 and 2 (time frame: Predose (0), 24, 48, 72, 96, 120, 216, 312, 480, 672, and 840 hours post-dose in both sessions 1 and 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660736, 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 9 Nov 2016.