A Study to Evaluate Pharmacokinetics, Safety and Efficacy of Albiglutide in Pediatric Subjects With Type 2 Diabetes Mellitus
NCT03015519
Withdrawn
The incidence of Type 2 Diabetes Mellitus (T2DM) is increasing day by day but the treatment options are limited in children and adolescents. Albiglutide, approved for the treatment of T2DM in adult population, is a novel analogue of glucagon-like peptide-1 (GLP-1) with a sufficiently long half-life to permit once a week injection. The study will be conducted in 2 parts: Part A is a single dose pharmacokinetic (PK) study to confirm the dose and safety of albiglutide in pediatric subjects aged 10... Read More
Gender:
ALL
Ages:
Between 10 years and 17 years
Trial Updated:
01/16/2019
Locations: GSK Investigational Site, Chicago, Illinois +2 locations
Conditions: Diabetes Mellitus, Type 2
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A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
NCT03492580
Completed
The primary purpose of study is to estimate the incidence and comparative effect on health outcomes: 1) hospitalization for heart failure, 2) below knee lower extremity amputation. The date of first exposure to the particular drug(s) in the database, where the exposure start is between 1-April-2013 to 15-May-2017 and outcome data for these participants will be analyzed and reported in this study.
Gender:
ALL
Ages:
All
Trial Updated:
08/24/2018
Locations: Janssen Investigative Site, Titusville, New Jersey
Conditions: Diabetes Mellitus, Type 2, Cardiovascular Diseases
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A Study Evaluating the Effect of Albiglutide on Gallbladder Emptying in Healthy Subjects
NCT02496221
Completed
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 com... Read More
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
03/09/2018
Locations: GSK Investigational Site, Baltimore, Maryland
Conditions: Diabetes Mellitus, Type 2
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Cardiovascular Outcomes in Participants With Type 2 Diabetes Mellitus (T2DM)
NCT03249506
Completed
The purpose of this study is to identify and evaluate the event rate of the composite endpoint of all-cause mortality (ACM) or hospitalization for heart failure (HF) for participants with Type 2 Diabetes mellitus (T2DM) and established cardiovascular (CV) disease among new users of sodium-glucose co-transporter 2 inhibitor (SGLT2i) as compared with new users of non-SGLT2i anti-hyperglycemic agent (AHA).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
11/17/2017
Locations: Health ResearchTx, LLC, Trevose, Pennsylvania
Conditions: Diabetes Mellitus, Type 2
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A Study of the Pharmacokinetics of Albiglutide in Normal and Renally Impaired Subjects.
NCT00938158
Completed
The purpose of this study is to assess the pharmacokinetics and safety of a single subcutaneously injected dose of albiglutide in subjects with type 2 diabetes mellitus with varying degrees of renal function, including subjects requiring hemodialysis.
Gender:
ALL
Ages:
Between 30 years and 75 years
Trial Updated:
07/18/2017
Locations: GSK Investigational Site, Anniston, Alabama +6 locations
Conditions: Diabetes Mellitus, Type 2
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A Drug Interaction Study With Albiglutide and Warfarin
NCT01147731
Completed
This open-label study evaluates the pharmacokinetics of warfarin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of warfarin.
Gender:
MALE
Ages:
Between 18 years and 55 years
Trial Updated:
06/21/2017
Locations: GSK Investigational Site, Austin, Texas
Conditions: Diabetes Mellitus, Type 2
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An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .
NCT01077505
Completed
This study will be an open-label study to evaluate the effect of albiglutide on the pharmacokinetics and pharmacodynamics of a standard oral contraceptive regimen (Brevicon). The primary objective of this study is to demonstrate the lack of effect of albiglutide doses on the pharmacokinetics of norethindrone and ethinyl estradiol in healthy female subjects.
Gender:
FEMALE
Ages:
Between 18 years and 40 years
Trial Updated:
06/13/2017
Locations: GSK Investigational Site, Austin, Texas
Conditions: Diabetes Mellitus, Type 2
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A Drug Interaction Study of Albiglutide and Digoxin
NCT01147718
Completed
This Phase I, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.
Gender:
ALL
Ages:
Between 18 years and 55 years
Trial Updated:
06/09/2017
Locations: GSK Investigational Site, Austin, Texas
Conditions: Diabetes Mellitus, Type 2
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A Drug Interaction Study of Simvastatin and Albiglutide
NCT01147692
Completed
This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. The primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.
Gender:
ALL
Ages:
Between 18 years and 55 years
Trial Updated:
06/07/2017
Locations: GSK Investigational Site, Austin, Texas
Conditions: Diabetes Mellitus, Type 2
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Incretin Regulation of Insulin Secretion in Monogenic Diabetes
NCT01795144
Completed
The purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications.
Gender:
ALL
Ages:
Between 18 years and 89 years
Trial Updated:
04/06/2017
Locations: University of Chicago, Chicago, Illinois
Conditions: Monogenic Diabetes
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A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
NCT01098539
Completed
This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
01/16/2017
Locations: GSK Investigational Site, Birmingham, Alabama +217 locations
Conditions: Diabetes Mellitus, Type 2
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A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
NCT01128894
Completed
This open-label study examines the efficacy and safety of albiglutide as compared with liraglutide in subjects with type 2 diabetes.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
01/09/2017
Locations: GSK Investigational Site, Birmingham, Alabama +173 locations
Conditions: Diabetes Mellitus, Type 2
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