Pharmacokinetics/Pharmacodynamics of Albiglutide

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Diabetes Mellitus, Type 2

Treatments

Biological: albiglutide (GSK716155)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01357889

114856

Details and patient eligibility

About

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.

Full 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.

Enrollment

283 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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