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Home > Protocol Summaries: Compounds > albiglutide > Protocol Summary for GLP110125

Protocol Summary for GLP110125

Protocol Summary
Protocol Id: GLP110125
Secondary Ids:
Title: See Detailed Description
Phase: phase 2
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 65,177
IND/IDE Serial Number: 000
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
Collaborators:
Brief Summary: This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.
Detailed Description: A 16-week, parallel-group, double-blind, randomized, placebo-controlled, multicenter, dose-ranging study to evaluate the efficacy, safety and tolerability of multiple doses and multiple treatment regimens of Albiglutide (GSK716155) with Byetta as an open-label active reference, in subjects with Type 2 Diabetes Mellitus.
Record Verification Date: February 2013
Status: Completed
Why Study Stopped:
Study Start Date: April 2007
Study Completion Date: May 2008
Study Completion Date Type: Actual
Primary Completion Date: May 2008
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Efficacy Study
Primary Outcomes:
  • Change in HbA1c after 16 weeks. 16 Weeks
Secondary Outcomes:
  • Change in HbA1c throughout the study. Evaluation of levels of GSK716155 in the blood, throughout the study. Changes in waist circumference, body weight, fasting plasma glucose, lipids, and other blood parameters after 16 weeks 16 Weeks
  • Change from baseline in FPG over time and at the end of the study Baseline to 16 weeks
  • Change from baseline in fasting fructosamine, fasting insulin, C-peptide, and glucagon over time and at the end of the study Baseline to 16 weeks
  • The subject's feelings and opinions concerning the effects of nausea and vomiting on daily life as assessed by the Functional Living Index - Emesis over time Baseline to 16 weeks
  • Change from baseline in HbA1c over time Baseline to 16 weeks
  • Proportion of subjects who achieve HbA1c (≤6.5%, <7%) over time and at the end of the study Baseline to 16 weeks
  • Subject-reported feelings of hunger and satiety as assessed by the Hunger, Craving and Fullness Questionnaire over time Baseline to 16 weeks
  • Population PK and PK/PD parameters Baseline to 16 weeks
  • Change from baseline in body weight and serum lipid profile (triglycerides, free fatty acids, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol) over time and at the end of the study Baseline to 16 weeks
  • Change from baseline in waist circumference and in percent change in body weight at Week 16 Baseline to 16 weeks
Conditions:
  • Diabetes Mellitus, Type 2
Keywords:
  • GLP-1,
  • Type 2 Diabetes,
  • pharmacokinetics,
  • pharmacodynamics,
  • GSK716155,
  • metformin,
  • exenatide
  • Type 2 Diabetes Mellitus
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age: 75 Year
Enrollment: 318
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information