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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: GSK716155 subcutaneous injections


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>In Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen. | Drug: GSK716155 subcutaneous injections<br>* 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.<br>|
| Experimental: Group B<br>In Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen. | Drug: GSK716155 subcutaneous injections<br>* 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.<br>|
| Experimental: Group C<br>In Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen. | Drug: GSK716155 subcutaneous injections<br>* 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.<br>|
| Experimental: Group D<br>In Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm. | Drug: GSK716155 subcutaneous injections<br>* 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.<br>|
| Experimental: Group E<br>In Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg. | Drug: GSK716155 subcutaneous injections<br>* 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.<br>|
| Experimental: Group F<br>In Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen. | Drug: GSK716155 subcutaneous injections<br>* 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.<br>|
| Experimental: Group G<br>In Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm. | Drug: GSK716155 subcutaneous injections<br>* 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.<br>|
| Experimental: Group H<br>In Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg. | Drug: GSK716155 subcutaneous injections<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic measurements at three different times after one dose. |  | Up to Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GSK716155 pharmacodynamics pharmacokinetics injection site