Diabetes Mellitus, Type 2Phase 4NCT02496221
A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
A Phase 4 study testing Albiglutide 50 mg and CCK (Kinevac) in people with Diabetes Mellitus, Type 2, run by GlaxoSmithKline at 1 site in United States.
Trial summary
Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and approved for the treatment of type 2 diabetes mellitus. The primary objective of this study is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder emptying. 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 50 mg and CCK (Kinevac)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2015to 13 Oct 2015
- 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 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
- Have venous access sufficient to allow for intravenous (IV) infusion and blood sampling as per protocol
- Subject's body mass index (BMI) is >=18 kilogram (kg)/meter(m)^2 and <=30 kg/m^2
- Male or
- Female: if she is not pregnant (as confirmed by a test at screening and at other timepoints), not lactating, and at least one of the following conditions applies: a) cannot bear children OR b) agrees to follow contraception requirements defined in the protocol
- Capable of giving signed informed consent
Who cannot join
- Alanine aminotransferase (ALT) >1.5x Upper limit of normal (ULN)
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- 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 milliseconds (msec)
- Systolic blood pressure is >=140 millimetre (mm) mercury (Hg) at Screening
- Diastolic blood pressure is >=90 mm Hg at Screening
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- Heart rate is >100 beats/min at Screening
- Fasting triglyceride level >300 milligram/decilitre at Screening
- History of cholecystitis or other gallbladder disease
- History of gallstones, biliary motility dysfunction, or any condition rendering the subject unsuitable for ultrasonography assessments
- Prior cholecystectomy or any other gallbladder or biliary ducts procedure, prior ileal or gastric surgery, or any other medical procedure that precluded gallbladder emptying
- History of significant cardiovascular or pulmonary dysfunction prior to screening
- History of thyroid dysfunction
- History of intestinal obstruction, ileus, lap-band, gastrointestinal surgery or any other procedures that in the opinion of the investigator could influence gastric emptying (e.g., gastrectomy, gastric bypass)
- History of acute or chronic pancreatitis
- History of abdominal pain of unknown cause
- History of severe gastrointestinal disease, including gastroparesis, inflammatory bowel disease, Crohn's disease, or irritable bowel syndrome
- 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
- Current or past use of medications that may have significantly affected gastrointestinal and/or gallbladder motility or pancreatic or hepatobiliary systems
- History of regular alcohol consumption within 6 months of the study
- Urinary cotinine levels indicative of smoking or history of regular use of tobacco- or nicotine-containing products within 3 months prior to screening
- Subject has a history of significant weight loss or is currently attempting weight loss
- History of sensitivity or contraindication 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 (e.g., exenatide, liraglutide, lixisenatide, dulaglutide)
- A biliary pathology as assessed by ultrasound
- An abnormal (i.e., outside the normal reference range) thyroid function test assessed by thyroid stimulating hormone at screening
- An abnormal amylase or lipase test at screening
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result
- A positive pre-study drug/alcohol screen
- A positive test for Human immunodeficiency virus (HIV) antibody
- A screening ultrasound which demonstrates inadequate imaging of gallbladder, main pancreatic duct, or common duct
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56-day period
- The subject participated in a clinical trial and received an investigational product within 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, Placebo Controlled, 2-way Cross-over Study Evaluating Effect of Albiglutide on Cholecystokinin-induced Gallbladder Emptying in Fasting Healthy Subjects
Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and approved for the treatment of type 2 diabetes mellitus. The primary objective of this study is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder emptying. To make this assessment, each study participant will receive a dose of albiglutide and a dose of placebo followed by cholecystokinin (CCK) infusion and ultrasound measurement of the gallbladder.
The study will be comprised of two periods and 20 subjects. The screening visit will occur within 42 days of the start of Treatment Period 1. The Treatment Periods will be separated by a washout period of a minimum of 42 days. Subjects will return for a follow-up visit after 28 days following the last dose of albiglutide or placebo. The total duration of a subject's participation from Screening to Follow-up will be approximately 17.5 weeks.
This study is a post marketing commitment to the United States Food and Drug Administration (USFDA).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Albiglutide 50 mg, Placebo, CCK (Kinevac)
- Keywords
- Cholecystokinin, ultrasonography, Albiglutide, Gallbladder ejection fraction
- 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 50 mgDrug
Albiglutide 50 mg pen is a single-use fixed dose, fully disposable pen injector system for SC delivery in the abdomen containing 67 mg lyophilized albiglutide and 0.65 mL diluents designed to deliver a dose of 50 mg in a volume of 0.5 mL after reconstitution
PlaceboDrug
Placebo is a single-use fixed dose, fully disposable pen injector system for SC delivery of 0.5 mL injector volume in the abdomen
CCK (Kinevac)Drug
CCK (Kinevac) will be infused intravenously. Kinevac is supplied in vials containing 5 microgram (mcg)/vial. Infusion prepared aseptically by adding 5 mL of Sterile Water for Injection United States Pharmacopeia (USP) to the vial to create a solution of 1 mcg/mL. Infuse 0.003 mcg/kg dose in 100 mL of Sodium Chloride Injection USP, 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Albiglutide / Placebo or Placebo / Albiglutide | Experimental | In treatment period 1, subjects will receive Albiglutide 50 mg or Placebo subcutaneously (SC) after fasting overnight for at least 10 hours according to randomization schedule on Day 1. Subject will also receive CCK (Kinevac) infusion intravenously for a period of 50 minutes after fasting overnight for at least 10 hours on Day 4. After washout period of a minimum of 42 days in treatment period 2, subjects will receive same treatment according to randomization schedule in a cross-over fashion Receives: Drug: Albiglutide 50 mg; Drug: Placebo; Drug: CCK (Kinevac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect
Gallbladder ejection fraction (EF) is defined as the reduction in gallbladder volume at any time point from Baseline divided by baseline gallbladder volume and multiplied by 100. Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.
Measured: Day 4 in each treatment period
Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF)
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.
Measured: Day 4 in each treatment period
Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).
Measured: Day 4 in each treatment period
Maximum Gallbladder Ejection Fraction Value During CCK Infusion
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).
Measured: Day 1 and Day 4 in each treatment period
Area Under the Effect Curve for Gallbladder Volume (AUEC VL)
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error is presented.
Measured: Day 4 in each treatment period
Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Adjusted mean and its standard error are presented.
Measured: Day 4 in each treatment period
Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).
Measured: Day 4 in each treatment period
Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion
Pancreatic duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error are presented. Baseline was calculated as the value at the indicated time point minus the Baseline value. Only those participants available at the indicated time points were analyzed.
Measured: Day 4 in each treatment period
Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion
Common bile duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error have been presented.
Measured: Day 4 in each treatment period
Secondary outcomes (6)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Baseline is defined as Day 1 (pre-dose) visit. SBP and DBP were measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 1 (pre-dose), Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.
Measured: Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (assessed up to a total of approximately 12 weeks)
Change From Baseline in Heart Rate
Baseline is defined as Day 1 (pre-dose) visit. Heart rate was measured in a semi-supine position after 5 minutes of rest, at each indicated time point. Assessments were performed on Day -1, Day 2, Day 3 and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4. Change from Baseline was calculated as value at indicated time point minus Baseline value. Only those participants available at the indicated time points (represented by n=X,X in the category titles) were analyzed.
Measured: Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (a total of approximately 12 weeks)
Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance
The following parameters were measured through blood sampling. Hematology: Hematocrit, Hemoglobin, Lymphocytes, Neutrophil Count, Platelet Count, While Blood Cell Count (WBC); Clinical Chemistry: Albumin, Calcium, Creatinine, Glucose, Magnesium, Phosphorus, Potassium, Sodium, Total carbon dioxide; Liver Function Tests: Alanine transaminase (ALT), Aspartate transaminase, Alkaline Phosphatase, Total Bilirubin, Total Bilirubin + ALT. Values were considered to be of potential clinical importance if they had a 'low' or 'high' flag with respect to a pre-defined clinical concern range. Only participants starting each period (represented by n=X) with a particular treatment were analyzed. The follow-up time point is not restricted to a treatment or treatment period.
Measured: Day -1 in each treatment period and Follow-up (at approximately Week 12)
Change From Baseline in Electrocardiogram (ECG) Parameters
Single 12-lead ECG was obtained in a semi-supine position after 5 minutes of rest at each indicated time point using an ECG machine that automatically calculated the heart rate and measured the PR, QRS, QT, and QT corrected by Fridericia's formula (QTcF) intervals. Change from Baseline was calculated as value at indicated time point minus Baseline value.
Measured: Baseline (Day -1) and Day 4 in each treatment period, and at Follow-up (at approximately Week 12)
Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, associated with liver injury and impaired liver function defined as alanine aminotransferase >=3 x upper limit of normal (ULN), and total bilirubin >=2 x ULN or international normalised ratio >1.5. AEs were classified as potentially drug-related, based on the investigator's judgement. Refer to the general AE/SAE module for a list of AEs and SAEs.
Measured: From Day -1 in treatment period 1 and up to Follow-up Visit (a total of approximately 12 weeks)
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Urine dipstick test was carried out on Day -1 and at Follow-up. Urinalysis parameters assessed were glucose, ketones, nitrite and protein. Dipstick results were categorized as Normal (glucose), Negative or Trace (ketones), and Negative (nitrite and protein). Only participants available at the indicated time points (as represented by n=X, X, X in the category titles) were analyzed. The resultant fields with no available data have been represented by 'NA'.
Measured: Day -1 and Follow-up (assessed up to a total of approximately 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study start11 Jun 2015
- Primary completion13 Oct 2015
- Study completion13 Oct 2015
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 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
- NCT02496221
- Sponsor's protocol ID
- 201834
- Status last verified
- Mar 2018
- First submitted
- 18 May 2015
- Last updated
- 5 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Shaddinger BC, Young MA, Billiard J, Collins DA, Hussaini A, Nino A. Effect of Albiglutide on Cholecystokinin-Induced Gallbladder Emptying in Healthy Individuals: A Randomized Crossover Study. J Clin Pharmacol. 2017 Oct;57(10):1322-1329. doi: 10.1002/jcph.940. Epub 2017 May 19.
PubMed 28543352
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Single-dose, Placebo Controlled, 2-way Cross-over Study Evaluating Effect of Albiglutide on Cholecystokinin-induced Gallbladder Emptying in Fasting Healthy Subjects
- ClinicalTrials.gov ID
- NCT02496221
- Acronym / sponsor ID
- 201834
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Cholecystokinin, ultrasonography, Albiglutide, Gallbladder ejection fraction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2015 (actual)
- Primary completion
- 13 Oct 2015 (actual)
- Study completion
- 13 Oct 2015 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Posted 21 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Albiglutide, a novel analogue of glucagon-like peptide-1 (GLP-1), has been developed and approved for the treatment of type 2 diabetes mellitus. The primary objective of this study is to assess if a single dose of albiglutide can affect cholecystokinin-induced gallbladder emptying. To make this assessment, each study participant will receive a dose of albiglutide and a dose of placebo followed by cholecystokinin (CCK) infusion and ultrasound measurement of the gallbladder.
The study will be comprised of two periods and 20 subjects. The screening visit will occur within 42 days of the start of Treatment Period 1. The Treatment Periods will be separated by a washout period of a minimum of 42 days. Subjects will return for a follow-up visit after 28 days following the last dose of albiglutide or placebo. The total duration of a subject's participation from Screening to Follow-up will be approximately 17.5 weeks.
This study is a post marketing commitment to the United States Food and Drug Administration (USFDA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Albiglutide / Placebo or Placebo / Albiglutide | Experimental | Drug: Albiglutide 50 mg, Drug: Placebo, Drug: CCK (Kinevac)In treatment period 1, subjects will receive Albiglutide 50 mg or Placebo subcutaneously (SC) after fasting overnight for at least 10 hours according to randomization schedule on Day 1. Subject will also receive CCK (Kinevac) infusion intravenously for a period of 50 minutes after fasting overnight for at least 10 hours on Day 4. After washout period of a minimum of 42 days in treatment period 2, subjects will receive same treatment according to randomization schedule in a cross-over fashion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between 18 and 65 years of age
- Healthy
- Have venous access sufficient to allow for intravenous (IV) infusion and blood sampling as per protocol
- Subject's body mass index (BMI) is >=18 kilogram (kg)/meter(m)^2 and <=30 kg/m^2
- Male or
Key exclusion criteria (36 listed)
- Alanine aminotransferase (ALT) >1.5x Upper limit of normal (ULN)
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- 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 milliseconds (msec)
- Systolic blood pressure is >=140 millimetre (mm) mercury (Hg) 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 50 mgAlbiglutide 50 mg pen is a single-use fixed dose, fully disposable pen injector system for SC delivery in the abdomen containing 67 mg lyophilized albiglutide and 0.65 mL diluents designed to deliver a dose of 50 mg in a volume of 0.5 mL after reconstitution | Drug | Albiglutide / Placebo or Placebo / Albiglutide |
| PlaceboPlacebo is a single-use fixed dose, fully disposable pen injector system for SC delivery of 0.5 mL injector volume in the abdomen | Drug | Albiglutide / Placebo or Placebo / Albiglutide |
| CCK (Kinevac)CCK (Kinevac) will be infused intravenously. Kinevac is supplied in vials containing 5 microgram (mcg)/vial. Infusion prepared aseptically by adding 5 mL of Sterile Water for Injection United States Pharmacopeia (USP) to the vial to create a solution of 1 mcg/mL. Infuse 0.003 mcg/kg dose in 100 mL of Sodium Chloride Injection USP, 0.9% | Drug | Albiglutide / Placebo or Placebo / Albiglutide |
Primary outcome
Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect
Time frame: Day 4 in each treatment period
Gallbladder ejection fraction (EF) is defined as the reduction in gallbladder volume at any time point from Baseline divided by baseline gallbladder volume and multiplied by 100. Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.
Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF)
Time frame: Day 4 in each treatment period
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error have been presented.
Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion
Time frame: Day 4 in each treatment period
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).
Maximum Gallbladder Ejection Fraction Value During CCK Infusion
Time frame: Day 1 and Day 4 in each treatment period
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).
Area Under the Effect Curve for Gallbladder Volume (AUEC VL)
Time frame: Day 4 in each treatment period
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Adjusted mean and its standard error is presented.
Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect
Time frame: Day 4 in each treatment period
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline gallbladder volume is the average of the 3 gallbladder volume measurements prior to CCK infusion on Day 4, for each treatment period. Adjusted mean and its standard error are presented.
Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion
Time frame: Day 4 in each treatment period
Gallbladder ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion).
Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion
Time frame: Day 4 in each treatment period
Pancreatic duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error are presented. Baseline was calculated as the value at the indicated time point minus the Baseline value. Only those participants available at the indicated time points were analyzed.
Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion
Time frame: Day 4 in each treatment period
Common bile duct ultrasonography was done at Day 1 (-15, -10, and -5 minutes [min] relative to start of albiglutide/placebo injection) and Day 4 ([prior to CCK infusion] -15, -10, -5 min, followed by [during CCK infusion] every 5 min between 0 and 50 min, then [after CCK infusion] at 60, 70, and 80 min, relative to the start of CCK infusion). Baseline is the average of the three diameter assessments at -15, -10, and -5 minutes relative to start of CCK infusion on Day 4. Change from Baseline was calculated as the value at the indicated time point minus the Baseline value. Adjusted mean and its standard error have been presented.
6 secondary outcomes
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (assessed up to a total of approximately 12 weeks)
Change From Baseline in Heart Rate
Time frame: Day -1, Baseline Day 1(Pre-dose), Day 2, Day 3, and 15 minutes (-15 min) prior to dosing and 80 min post dosing on Day 4 in each treatment period and Follow-up (a total of approximately 12 weeks)
Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance
Time frame: Day -1 in each treatment period and Follow-up (at approximately Week 12)
Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline (Day -1) and Day 4 in each treatment period, and at Follow-up (at approximately Week 12)
Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event
Time frame: From Day -1 in treatment period 1 and up to Follow-up Visit (a total of approximately 12 weeks)
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick
Time frame: Day -1 and Follow-up (assessed up to a total of approximately 12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28543352Shaddinger BC, Young MA, Billiard J, Collins DA, Hussaini A, Nino A. Effect of Albiglutide on Cholecystokinin-Induced Gallbladder Emptying in Healthy Individuals: A Randomized Crossover Study. J Clin Pharmacol. 2017 Oct;57(10):1322-1329. doi: 10.1002/jcph.940. Epub 2017 May 19.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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 4 study testing Albiglutide 50 mg and CCK (Kinevac) 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 7 inclusion and 36 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 5 Apr 2018. 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 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 21 Jul 2016). 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?
Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect (time frame: Day 4 in each treatment period). The study lists 9 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 NCT02496221, 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 5 Apr 2018.