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

May 19, 2011
May 2, 2013
July 2011
October 2012   (final data collection date for primary outcome measure)
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
  • Area under the plasma concentration versus time curve (AUC) 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) following single-dose administration of albiglutide
  • Maximum plasma concentration (Cmax) of albiglutide [ Time Frame: 0, 24, 48, 86, 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 maximum observed plasma concentration (Cmax) following single-dose administration of albiglutide
Complete list of historical versions of study NCT01357889 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Pharmacokinetics/Pharmacodynamics of Albiglutide
A Multidose Study in Subjects With Type 2 Diabetes Mellitus to Assess the Pharmacokinetics and Pharmacodynamics of Albiglutide

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Biological: albiglutide (GSK716155)
    subcutaneous injection administered once a week
    Other Name: process 2
  • Biological: albiglutide (GSK716155)
    subcutaneous injection administered once a week
    Other Name: process 3
  • Active Comparator: process 2 albiglutide
    albiglutide 30mg from process 2 drug substance
    Intervention: Biological: albiglutide (GSK716155)
  • Active Comparator: process 3 albiglutide
    albiglutide 30mg from process 3 drug substance
    Intervention: Biological: albiglutide (GSK716155)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
283
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01357889
114856
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP