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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00394030
First received: October 27, 2006
Last updated: May 31, 2012
Last verified: March 2011
History of Changes
  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
Diabetes Mellitus, Type 2
 Drug: GSK716155 subcutaneous injections
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:

U.S. FDA Resources

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)
Intervention Details:
    Drug: GSK716155 subcutaneous injections
    Other Name: GSK716155 subcutaneous injections
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 GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00394030     History of Changes
Other Study ID Numbers: GLP107724
Study First Received: October 27, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
GSK716155 pharmacodynamics pharmacokinetics injection site

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013