Diabetes Mellitus, Type 2
Conditions
Keywords
GSK716155 pharmacodynamics pharmacokinetics injection site
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 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.
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
Interventions
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic measurements for different injection sites after one dose. | Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic measurements at three different times after one dose. | Up to Day 29 |
Countries
United States
Outcome results
None listed