Clinical trial NCT00394030: Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers
Official title: An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects With Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: GSK716155 pharmacodynamics pharmacokinetics injection site
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, 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.

Detailed description: An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers

Eligibility criteria: Inclusion criteria:

* They can be healthy volunteers or subjects with type 2 diabetes mellitus that has been diagnosed for at least three months. T2DM subjects must be taking either (1) no medication for their diabetes or (2) taking metformin or (3) taking a TZD (thiazolidinedione).
* Subjects must have a BMI between 25 and 40 kg/m² and weigh at least 50kg.
* Women must be of non-childbearing potential.

Exclusion criteria:

* Bloodwork that meets certain criteria (for example, total cholesterol \> 240 mg/dL)
* Clinically significant hepatic enzyme elevation
* HbA1c less than 6.5 or greater than 10
* 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 prior to and during the in-patient clinic stays
* Unwilling to abstain from caffeine- or xanthine-containing products prior to and during the in-patient clinic stays
* 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.

Primary outcomes:
measure: Pharmacokinetic measurements for different injection sites after one dose.
timeFrame: Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours
Secondary outcomes:
measure: Pharmacodynamic measurements at three different times after one dose.
timeFrame: Up to Day 29
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Walnut Creek
country: United States
facility: GSK Investigational Site
state: California
city: Miramar
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Morrisville
country: United States
facility: GSK Investigational Site
state: North Carolina
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.