Pharmacokinetics/Pharmacodynamics of Albiglutide

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01357889
First received: May 19, 2011
Last updated: May 2, 2013
Last verified: April 2013
  Purpose

The first part of the study includes a single dose treatment period to evaluate the pharmacokinetic bioequivalence of a subcutaneous injection of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic and pharmacodynamic parameters and safety and tolerability of repeat doses of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Biological: albiglutide (GSK716155)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multidose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Pharmacokinetics and Pharmacodynamics of Albiglutide

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) and maximum observed plasma concentration (Cmax) of albiglutide [ Time Frame: 0, 24, 48, 96, 216, 312, 480 and 672 hours post-dose ] [ Designated as safety issue: No ]
    Bioequivalence of albiglutide from process 2 and process 3 drug substance using the area under the concentration time curve (AUC) and the maximum observed plasma concentration (Cmax) following single-dose administration of albiglutide


Secondary Outcome Measures:
  • Trough (pre-dose) plasma concentrations of albiglutide [ Time Frame: pre-dose at weeks 5, 9, 13 and 17 ] [ Designated as safety issue: No ]
    Evaluation of trough (predose) plasma concentrations of albiglutide following repeat dose administration

  • Anti-albiglutide antibody formation [ Time Frame: pre-dose at weeks 5, 9, 13 and 17 ] [ Designated as safety issue: No ]
    Assessment of the anti-albiglutide antibody formation (immunogenicity) following repeat-dose administration

  • Number of participants with adverse events [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Comparison of number of participants with adverse events after treatment with process 2 or process 3 albiglutide


Enrollment: 283
Study Start Date: July 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: process 2 albiglutide
albiglutide 30mg from process 2 drug substance
Biological: albiglutide (GSK716155)
subcutaneous injection administered once a week
Other Name: process 2
Active Comparator: process 3 albiglutide
albiglutide 30mg from process 3 drug substance
Biological: albiglutide (GSK716155)
subcutaneous injection administered once a week
Other Name: process 3

Detailed Description:

This is a randomized, double-blind, multicenter, 2 parallel group study. The first part of the treatment period will evaluate the pharmacokinetic bioequivalence of a single dose of a subcutaneous injection of 30mg of albiglutide from process 2 drug substance compared with process 3 drug substance. The second part of the treatment period will evaluate additional pharmacokinetic parameters, pharmacodynamic parameters, immunogenicity, effects on glycosylated hemoglobin and fasting plasma glucose, and safety and tolerability of repeat doses of subcutaneous injections of 30mg of albiglutide given weekly for 12 weeks from process 2 drug substance compared with process 3 drug substance. Subjects with type 2 diabetes whose glycemia is inadequately controlled on their current regimen of diet and exercise or stable dose of metformin will be recruited into the study.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a historical diagnosis of type 2 diabetes mellitus who are experiencing inadequate glycemic control on their current regimen of diet and exercise or on a stable dose of metformin
  • Body mass index ≥20 kg/m2 and ≤45 kg/m2
  • Fasting C-peptide ≥0.8 ng/mL (≥0.26 nmol/L)
  • Thyroid-stimulating hormone level is normal or clinically euthyroid
  • Female subjects of childbearing potential (i.e., not surgically sterile and/or not postmenopausal) must be practicing adequate contraception.

Exclusion Criteria:

  • Current ongoing symptomatic biliary disease or history of pancreatitis
  • History of significant GI surgery
  • Recent clinically significant cardiovascular and/or cerebrovascular disease
  • History of human immunodeficiency virus infection
  • History of, or current hepatic disease
  • History of alcohol or substance abuse
  • Female subject is pregnant, lactating, or <6 weeks postpartum
  • History of type 1 diabetes
  • Receipt of any investigational drug within the 30 days, or 5 half-lives whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of any GLP-1 agents including albiglutide
  • History of, or family history of thyroid disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357889

Locations
United States, Florida
GSK Investigational Site
Hallandale Beach, Florida, United States, 33009
GSK Investigational Site
Jacksonville, Florida, United States, 32205
GSK Investigational Site
Orlando, Florida, United States, 32822
GSK Investigational Site
Tampa, Florida, United States, 33603
United States, Georgia
GSK Investigational Site
Blue Ridge, Georgia, United States, 30513
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40504
GSK Investigational Site
Paducah, Kentucky, United States, 42003
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27405
United States, South Carolina
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77074
GSK Investigational Site
Irving, Texas, United States, 75039
GSK Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01357889     History of Changes
Other Study ID Numbers: 114856
Study First Received: May 19, 2011
Last Updated: May 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
pharmacokinetics
pharmacodynamics
GSK716155
albiglutide

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014