Clinical trial NCT00530309: Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus
Official title: Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus -A Phase I/II Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of GSK716155 in Japanese Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: GLP-1
type 2 diabeted mellitus
safety
GSK716155
GLP-1 receptor agonist
tolerability
pharmacokinetics
pharmacodynamics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus


Eligibility criteria: Inclusion criteria:

* Type 2 diabetes mellitus diagnosed at least 3 months with FPG level \<=240mg/dL and HbA1c between 6.5% and 10% inclusive.
* Must be diet controlled - OR - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.
* Must have a BMI:\<=35kg/m2, 20 to 70 years of age inclusive.
* Woman must be of non-childbearing potential.

Exclusion criteria:

* Positive test result for either syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, or HTLV-1 antibody.
* Clinically significant hepatic enzyme elevation.
* History of metabolic disease other than T2DM.
* Previous use of insulin as a treatment for diabetes within 3 months.
* History of severe gastrointestinal disease.
* Clinically significant cardiovascular disease.
* Significant renal disease as defined by screening lab test.
* History of drug (including albumin or albumin containing agents) allergy.
* History of alcohol or drug abuse.
* Donation of blood in excess of 400mL within previous 4 months.
* Previously received any GLP-1 mimetic or any other albumin-containing products.

Primary outcomes:
measure: Plasma concentrations and PD parameters over time and at the end of study
timeFrame: Up to Week 9
Secondary outcomes:
measure: Other metabolic parameters at the end of study
timeFrame: Up to Week 9
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Seino Y, Nakajima H, Miyahara H, Kurita T, Bush MA, Yang F, Stewart MW. Safety, tolerability, pharmacokinetics and pharmacodynamics of albiglutide, a long-acting GLP-1-receptor agonist, in Japanese subjects with type 2 diabetes mellitus. Curr Med Res Opin. 2009 Dec;25(12):3049-57. doi: 10.1185/03007990903372999.
citation: 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.