Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00394030

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: GSK716155 subcutaneous injections	Phase I

MedlinePlus related topics: Diabetes

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Pharmacokinetic measurements for different injection sites after one dose.

Secondary Outcome Measures:

Pharmacodynamic measurements at three different times after one dose.

Enrollment:	63
Study Start Date:	October 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00394030

Locations

United States, California
GSK Investigational Site
Long Beach, California, United States, 90806
GSK Investigational Site
Walnut Creek, California, United States, 94598
United States, Florida
GSK Investigational Site
Miramar, Florida, United States, 33025
GSK Investigational Site
Orlando, Florida, United States, 32809
United States, North Carolina
GSK Investigational Site
Morrisville, North Carolina, United States, 27560
United States, Texas
GSK Investigational Site
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	GLP107724
Study First Received:	October 27, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00394030
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

GSK716155 pharmacodynamics pharmacokinetics injection site

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Healthy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009