Pharmacokinetics/Pharmacodynamics of Albiglutide

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

283 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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process 2 albiglutide

albiglutide 30mg from process 2 drug substance

Group Type ACTIVE_COMPARATOR

albiglutide (GSK716155)

Intervention Type BIOLOGICAL

subcutaneous injection administered once a week

process 3 albiglutide

albiglutide 30mg from process 3 drug substance

Group Type ACTIVE_COMPARATOR

albiglutide (GSK716155)

Intervention Type BIOLOGICAL

subcutaneous injection administered once a week

Interventions

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albiglutide (GSK716155)

subcutaneous injection administered once a week

Intervention Type BIOLOGICAL

albiglutide (GSK716155)

subcutaneous injection administered once a week

Intervention Type BIOLOGICAL

Other Intervention Names

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process 2 process 3

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Dothan, Alabama, United States

Site Status

GSK Investigational Site

Long Beach, California, United States

Site Status

GSK Investigational Site

Riverside, California, United States

Site Status

GSK Investigational Site

Hallandale, Florida, United States

Site Status

GSK Investigational Site

Jacksonville, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Blue Ridge, Georgia, United States

Site Status

GSK Investigational Site

Lexington, Kentucky, United States

Site Status

GSK Investigational Site

Paducah, Kentucky, United States

Site Status

GSK Investigational Site

Gulfport, Mississippi, United States

Site Status

GSK Investigational Site

Picayune, Mississippi, United States

Site Status

GSK Investigational Site

Omaha, Nebraska, United States

Site Status

GSK Investigational Site

Greensboro, North Carolina, United States

Site Status

GSK Investigational Site

Columbus, Ohio, United States

Site Status

GSK Investigational Site

Mason, Ohio, United States

Site Status

GSK Investigational Site

Bensalem, Pennsylvania, United States

Site Status

GSK Investigational Site

Columbia, South Carolina, United States

Site Status

GSK Investigational Site

North Myrtle Beach, South Carolina, United States

Site Status

GSK Investigational Site

Simpsonville, South Carolina, United States

Site Status

GSK Investigational Site

Clarksville, Tennessee, United States

Site Status

GSK Investigational Site

McKenzie, Tennessee, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Irving, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Sugarland, Texas, United States

Site Status

GSK Investigational Site

Bountiful, Utah, United States

Site Status

GSK Investigational Site

Lewisburg, West Virginia, United States

Site Status

Countries

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United States

References

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Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

Reference Type DERIVED

PMID: 25387217 (View on PubMed)

Study Documents

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