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Clinical Trial Details

Trial ID: L4681
Source ID: NCT02496221
Associated Drug: Albiglutide 50 Mg
Title: A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02496221/results
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Albiglutide 50 mg|DRUG: Placebo|DRUG: CCK (Kinevac)
Outcome Measures: Primary: 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., 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., 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)., 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)., 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., 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., 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)., 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., 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., Day 4 in each treatment period | Secondary: 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., 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., 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., 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., 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., 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'., Day -1 and Follow-up (assessed up to a total of approximately 12 weeks)
Sponsor/Collaborators: Sponsor: GlaxoSmithKline
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 20
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2015-06-11
Completion Date: 2015-10-13
Results First Posted: 2016-07-21
Last Update Posted: 2018-04-05
Locations: GSK Investigational Site, Baltimore, Maryland, 21225, United States
URL: https://clinicaltrials.gov/show/NCT02496221