Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period
Completed
Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 \[SGLT2\] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
03/15/2022
Locations: Investigational Site Number 8400139, Austin, Texas +11 locations
Conditions: Type 2 Diabetes Mellitus
Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus
Completed
This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment grou... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
11/13/2020
Locations: GSK Investigational Site, Austin, Texas +7 locations
Conditions: Diabetes Mellitus, Type 2
Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
Completed
Albiglutide is an analogue of glucagon-like peptide-1 (GLP-1), used to treat type 2 diabetes This study will test whether albiglutide affects the occurrence of major cardiovascular events such as heart attacks or strokes and other important medical outcomes in persons with type 2 diabetes, when used alone or added to other diabetes treatments.
Gender:
ALL
Ages:
40 years and above
Trial Updated:
02/11/2019
Locations: GSK Investigational Site, Arlington, Texas +17 locations
Conditions: Diabetes Mellitus
A Drug Interaction Study With Albiglutide and Warfarin
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
An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .
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
A Drug Interaction Study of Albiglutide and Digoxin
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
A Drug Interaction Study of Simvastatin and Albiglutide
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
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
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, Arlington, Texas +31 locations
Conditions: Diabetes Mellitus, Type 2
Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
Completed
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,... Read More
Gender:
ALL
Ages:
Between 18 years and 65 years
Trial Updated:
11/08/2016
Locations: GSK Investigational Site, Austin, Texas
Conditions: Diabetes Mellitus, Type 2