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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: GSK716155 subcutaneous injections

Study type: Interventional

Funder types: Industry

Identifiers

NCT00394030

GLP107724

Details and patient eligibility

About

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.

Full 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

Enrollment: 63 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 8 patient groups

Group A

Experimental group

Description:

In Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen.

Treatment:

Drug: GSK716155 subcutaneous injections

Group B

Experimental group

Description:

In Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen.

Treatment:

Drug: GSK716155 subcutaneous injections

Group C

Experimental group

Description:

In Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen.

Treatment:

Drug: GSK716155 subcutaneous injections

Group D

Experimental group

Description:

In Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm.

Treatment:

Drug: GSK716155 subcutaneous injections

Group E

Experimental group

Description:

In Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg.

Treatment:

Drug: GSK716155 subcutaneous injections

Group F

Experimental group

Description:

In Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen.

Treatment:

Drug: GSK716155 subcutaneous injections

Group G

Experimental group

Description:

In Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm.

Treatment:

Drug: GSK716155 subcutaneous injections

Group H

Experimental group

Description:

In Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg.

Treatment:

Drug: GSK716155 subcutaneous injections