Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study
NCT05220917
Unknown
To perform an observational analysis to emulate a target trial (i.e., a hypothetical pragmatic trial that would have answered the causal question of interest) comparing the effectiveness and safety of sodium-glucose cotransporter-2 inhibitors (SGLT2i), glucagon-like peptide 1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors (DPP-4i), and sulfonylureas (SU), at the class and individual agent level, in head-to-head comparisons in patients with type 2 diabetes (T2D).
Gender:
ALL
Ages:
18 years and above
Trial Updated:
02/17/2022
Locations: Brigham and Women's Hospital, Boston, Massachusetts
Conditions: Cardiovascular Events, Type2 Diabetes, Renal Disease
Register for Updates
Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus
NCT02229227
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, Searcy, Arkansas +157 locations
Conditions: Diabetes Mellitus, Type 2
Register for Updates
Stepping-down Approach in Patients With Chronic Poorly-controlled Diabetes on Advanced Insulin Therapy?
NCT02846233
Completed
In traditional step-up approach, the patients with poorly-controlled type 2 diabetes are instructed to take up to 4 insulin injections daily or multiple daily injections (MDI) as the most advanced therapy. However, a significant number of these patients continue to have poor diabetes control. The most common reason is the noncompliance with multiple injections and the patient's reluctance to accept insulin-induced weight gain. More recently, the algorithm in diabetes management has significantly... Read More
Gender:
ALL
Ages:
21 years and above
Trial Updated:
10/20/2020
Locations: UCSF Fresno, Fresno, California
Conditions: Type 2 Diabetes Mellitus
Register for Updates
An Exploratory Study on the Effects of Repeat Doses of Albiglutide Compared to Exenatide on Gastric Myoelectrical Activity and Gastric Emptying in Type 2 Diabetes Mellitus Subjects
NCT02793154
Terminated
The primary objective of this study is to compare the effect of albiglutide and exenatide on gastric myoelectrical activity (GMA), gastric emptying (GE) and nausea (as measured by visual analogue scale \[VAS\]) in subjects with type 2 diabetes mellitus (T2DM). The study is divided in two parts. Part A will characterize the GMA, GE and nausea response to exenatide and confirm exenatide as a positive control for Part B. Part B will compare the effects of albiglutide and exenatide on GMA, GE and na... Read More
Gender:
ALL
Ages:
Between 18 years and 60 years
Trial Updated:
10/08/2020
Locations: GSK Investigational Site, Louisville, Kentucky +1 locations
Conditions: Diabetes Mellitus, Type 2
Register for Updates
A Study Comparing the Effect of Albiglutide With Exenatide on Regional Brain Activity Related to Nausea in Healthy Subjects
NCT02802514
Terminated
The drug effects will be studied after a single dose of 50 milligram (mg) albiglutide and a single dose of 10 microgram exenatide, to gain insight into the central mechanisms of nausea associated with Glucagon-like peptide-1 receptor (GLP-1R) agonists. This study will explore the potential differences at the expected time of maximum concentration (Cmax) between a long-acting (albiglutide) and short-acting (exenatide) GLP-1R agonist in brain activation of healthy volunteers assessed by magnetic r... Read More
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
10/08/2020
Locations: GSK Investigational Site, Boston, Massachusetts
Conditions: Diabetes Mellitus
Register for Updates
Cardiovascular Outcomes and HbA1c Among Patients With Type 2 Diabetes Newly Initiating GLP1RAs vs Basal Insulin
NCT04034524
Unknown
This study will compare hemoglobin a1c (HbA1c) and cardiovascular (CV) outcomes among patients with type 2 diabetes newly initiating a GLP1-receptor agonist or basal insulin.
Gender:
ALL
Ages:
18 years and above
Trial Updated:
07/07/2020
Locations: Brigham and Women's Hospital, Boston, Massachusetts
Conditions: Diabetes Mellitus, Type 2
Register for Updates
Extension to Study 200952 to Evaluate the Long-term Safety, Tolerability and Pharmacodynamics of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus Subjects
NCT02750930
Terminated
Albiglutide has been developed for the treatment of type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise, as monotherapy, or in combination with existing therapies and has been approved by the United States (US) Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory agencies. This is a 26 week, open-label, single group, multicenter, extension study to Study 200952. This extension study will provide extended safety, tolerability and immunogenici... Read More
Gender:
ALL
Ages:
All
Trial Updated:
07/11/2019
Locations: GSK Investigational Site, Phoenix, Arizona +26 locations
Conditions: Diabetes Mellitus, Type 2
Register for Updates
Safety and Efficacy Study of Albiglutide Liquid Drug Product in Type 2 Diabetes Mellitus
NCT02683746
Completed
This is a phase III, randomized, double-blind, multicenter, parallel group, repeat-dose, study of 26 weeks duration to evaluate the efficacy, safety, tolerability and pharmacodynamic response of albiglutide liquid drug product relative to the commercial lyophilized drug product. The study will specifically evaluate the potential for immunogenicity (example \[e.g.\] incidences of anti-drug antibodies \[ADA\]) and injection site reactions (ISRs). Albiglutide is a novel analogue of glucagon-like p... Read More
Gender:
ALL
Ages:
Between 18 years and 80 years
Trial Updated:
07/10/2019
Locations: GSK Investigational Site, Birmingham, Alabama +69 locations
Conditions: Diabetes Mellitus, Type 2
Register for Updates
Effect of Albiglutide, When Added to Standard Blood Glucose Lowering Therapies, on Major Cardiovascular Events in Subjects With Type 2 Diabetes Mellitus
NCT02465515
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, Birmingham, Alabama +607 locations
Conditions: Diabetes Mellitus
Register for Updates
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
Register for Updates
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
Register for Updates
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
Register for Updates