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

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00394030

Run by

GlaxoSmithKline

People needed

63

Starts

2006-10-16

Expected to finish

2007-03-20

Last updated by the study team

2017-09-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Miramar, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Morrisville, North Carolina, United States
• GSK Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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