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

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

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.