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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00394030
• Other study ID #: GLP107724
• Status: Completed
• Phase: Phase 1
• First received: October 27, 2006
• Last updated: September 8, 2017
• Start date: October 16, 2006
• Est. completion date: March 20, 2007

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 20, 2007
• Est. primary completion date: March 20, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Miramar	Florida
United States	GSK Investigational Site	Morrisville	North Carolina
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic measurements for different injection sites after one dose.		Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours
Secondary	Pharmacodynamic measurements at three different times after one dose.		Up to Day 29

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study GLP107724 can be found on the GSK Clinical Study Register.