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
NCT02787551
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 8400064, Birmingham, Alabama +123 locations
Conditions: Type 2 Diabetes Mellitus
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Finding the Cause for Post-Transplant Diabetes Mellitus After Allogeneic Hematopoietic Cell Transplant
NCT03415139
Unknown
This clinical research studies the physiology and immunology of new-onset post-transplant diabetes mellitus in patients undergoing allogeneic stem cell transplantation. Oral glucose tolerance tests (OGTT), hyperglycemic clamps, and immune assays will be used to define the mechanisms associated with abnormal glucose homeostasis following stem cell transplantation. Information from this clinical trial could be used to develop standardized screening procedures or to develop optimal treatment strate... Read More
Gender:
ALL
Ages:
Between 18 years and 90 years
Trial Updated:
03/10/2022
Locations: Vanderbilt University Medical Center, Nashville, Tennessee
Conditions: Diabetes Mellitus, Cancer
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Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes
NCT04133922
Withdrawn
GLP-1 increases skeletal and cardiac microvascular perfusion and improves insulin's microvascular responses in human subjects with T1DM, leading to improved metabolic insulin responses, endothelial function, and increased muscle oxygenation
Gender:
ALL
Ages:
Between 18 years and 40 years
Trial Updated:
03/07/2022
Locations: University of Virginia, Charlottesville, Virginia
Conditions: Type 1 Diabetes, Insulin Sensitivity/Resistance
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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
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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
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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
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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
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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
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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
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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
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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
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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
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