Clinical trial NCT00354536: In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
Official title: A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: GSK716155
albiglutide
pharmacodynamics
pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.


Eligibility criteria: Inclusion criteria:

* Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months.
* Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea.
* Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study.
* Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg.
* Women must be of non-childbearing potential.

Exclusion criteria:

* Laboratory values that meet certain criteria (for example, total cholesterol \> 240 mg/dL).
* Clinically significant hepatic enzyme elevation.
* Fasting plasma glucose greater than 240mg/dL.
* Positive test result for Hepatitis B surface antigen, positive Hepatitis C or HIV.
* Any major illness other than diabetes.
* Previous use of insulin as treatment for diabetes.
* Significant renal disease as defined by screening lab tests.
* History of drug or other allergy, which in the opinion of the investigator contradicts subject participation.
* Smoking or use of nicotine-containing products within the previous 6 months.
* History of alcohol or drug abuse.
* Unwilling to abstain from alcohol during the study.
* Unwilling to abstain from caffeine- or xanthine-containing products during the study.
* Use of St. John's Wort during the study.
* Has donated 500 nL or more blood within 56 days of dosing or plans to donate blood in the month following study participation.
* Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.

Primary outcomes:
measure: blood plasma levels of GSK716155
timeFrame: on days 2 & 9
Secondary outcomes:
measure: blood plasma levels of GSK716155
timeFrame: on days 2 & 9
Other outcomes:
Locations:
city: Miramar
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.