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A Randomized, Open-Label, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine as Compared With the Combination of Insulin Glargine and Preprandial Lispro Insulin in Subjects With Type 2 Diabetes Mellitus
This study will examine the safety and efficacy of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes.
This randomized, open-label, active-controlled, parallel-group, multicenter study evaluates the safety and efficacy of a weekly subcutaneously injected dose of albiglutide in combination with insulin glargine as compared with the combination of insulin glargine and preprandial lispro insulin in subjects with type 2 diabetes. Subjects with a historical diagnosis of type 2 diabetes who are inadequately controlled despite the use of insulin glargine or other intermediate- or long-acting insulins for \>/= 6 months but \< 5 years, with or without oral antidiabetic medications, who are unable to achieve a glycosylated hemoglobin value of \< 7% will be recruited into the study. Subjects must also be willing and capable of pursuing an intensive regimen of both basal and preprandial insulin.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Dothan, Alabama, United States
GSK Investigational Site
Gilbert, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Searcy, Arkansas, United States
GSK Investigational Site
Chino, California, United States
GSK Investigational Site
Commerce, California, United States
GSK Investigational Site
Fresno, California, United States
Start Date
September 1, 2009
Primary Completion Date
October 1, 2011
Completion Date
May 1, 2012
Last Updated
January 11, 2017
586
ACTUAL participants
albiglutide + insulin glargine
BIOLOGICAL
insulin glargine + preprandial lispro insulin
DRUG
Lead Sponsor
GlaxoSmithKline
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06861062