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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00394030
First Posted: October 31, 2006
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Diabetes Mellitus, Type 2 Drug: GSK716155 subcutaneous injections Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Pharmacokinetic measurements for different injection sites after one dose. [ Time Frame: Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours ]

Secondary Outcome Measures:
  • Pharmacodynamic measurements at three different times after one dose. [ Time Frame: Up to Day 29 ]

Enrollment: 63
Actual Study Start Date: October 16, 2006
Study Completion Date: March 20, 2007
Primary Completion Date: March 20, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
In Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen.
Drug: GSK716155 subcutaneous injections
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
Experimental: Group B
In Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen.
Drug: GSK716155 subcutaneous injections
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
Experimental: Group C
In Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen.
Drug: GSK716155 subcutaneous injections
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
Experimental: Group D
In Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm.
Drug: GSK716155 subcutaneous injections
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
Experimental: Group E
In Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg.
Drug: GSK716155 subcutaneous injections
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
Experimental: Group F
In Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen.
Drug: GSK716155 subcutaneous injections
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
Experimental: Group G
In Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm.
Drug: GSK716155 subcutaneous injections
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
Experimental: Group H
In Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg.
Drug: GSK716155 subcutaneous injections
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: GLP107724
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: GLP107724
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: GLP107724
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: GLP107724
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: GLP107724
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: GLP107724
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: GLP107724
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00394030     History of Changes
Other Study ID Numbers: GLP107724
First Submitted: October 27, 2006
First Posted: October 31, 2006
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

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