Status:
COMPLETED
Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 s...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 16 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2007
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00394030
Start Date
October 16 2006
End Date
March 20 2007
Last Update
September 11 2017
Active Locations (6)
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1
GSK Investigational Site
Long Beach, California, United States, 90806
2
GSK Investigational Site
Walnut Creek, California, United States, 94598
3
GSK Investigational Site
Miramar, Florida, United States, 33025
4
GSK Investigational Site
Orlando, Florida, United States, 32809