Phase 4
N=20
A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT02496221 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect — 47.4352; 38.4331 Percent of gallbladder EF — p=0.1229
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Albiglutide 50 mg (Drug); Placebo (Drug); CCK (Kinevac) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Absolute Value of Gallbladder Ejection Fraction (Emax GEF) During Cholecystokinin (CCK) Infusion, as a Measure of Maximum Effect |
47.4352; 38.4331 | 0.1229 |
| PRIMARY Area Under the Effect Curve for Gallbladder Ejection Fraction (AUEC GEF) |
1004.2510; 458.2926 | 0.1291 |
| PRIMARY Time at Which the Maximum Effect (Emax GEF) Occurred (TEMAXEF) During the CCK Infusion |
37.64706; 32.94118 | — |
| PRIMARY Maximum Gallbladder Ejection Fraction Value During CCK Infusion |
44.5989; 28.2997 | 0.0317 sig |
| PRIMARY Area Under the Effect Curve for Gallbladder Volume (AUEC VL) |
610.5642; 863.1741 | 0.0291 sig |
| PRIMARY Maximum Absolute Change From Baseline in Value of Gallbladder Volume (Emax VL) During CCK Infusion, as a Measure of Maximum Effect |
8.8385; 8.4637 | 0.7961 |
| PRIMARY Time at Which the Maximum Effect (Emax VL) Occurred (TEmax VL) During the CCK Infusion |
37.64706; 32.94118 | — |
| PRIMARY Maximum Change From Baseline in Main Pancreatic Duct Diameter During CCK Infusion |
0.04359; 0.04511 | 0.9424 |
| PRIMARY Maximum Change From Baseline in Common Bile Duct Diameter During CCK Infusion |
0.08814; 0.07358 | 0.0733 |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) |
2.5; 2.5; 4.2; 4.3; 4.8; 0.4 | — |
| SECONDARY Change From Baseline in Heart Rate |
2.4; 4.3; 4.7; 7.9; 3.8; 8.5 | — |
| SECONDARY Number of Participants With Clinical Chemistry and Hematology Abnormalities of Potential Clinical Importance |
1; 2; 1; 1; 1 | — |
| SECONDARY Change From Baseline in Electrocardiogram (ECG) Parameters |
2.1; 2.2; -1.8; -0.7; -5.0; -19.9 | — |
| SECONDARY Part A: Number of Participants With at Least One Non-serious Adverse Event (AE), Serious Adverse Event (SAE), or Drug-related Adverse Event |
8; 9; 0; 0; 5; 6 | — |
| SECONDARY Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick |
18; 20; NA; NA; NA; 19 | — |
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. 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).
Eligibility Criteria
Inclusion Criteria
- 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 1.5x Upper limit of normal (ULN)
- Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 450 milliseconds (msec)
- Systolic blood pressure is >=140 millimetre (mm) mercury (Hg) at Screening
- Diastolic blood pressure is >=90 mm Hg at Screening
- 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
Data sourced from ClinicalTrials.gov (NCT02496221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.