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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: GSK716155 subcutaneous injections

• Registration Number: NCT00394030
• Lead Sponsor: GlaxoSmithKline

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

Study Timeline

• Study Start: 2006-10-16
• Study First Submitted: 2006-10-27
• Study First Submitted QC: 2006-10-27
• Study First Posted: 2006-10-31
• Primary Completion: 2007-03-20
• Study Completion: 2007-03-20
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	GSK716155 subcutaneous injections	In Group A healthy subjects will be randomized to receive 16 milligram (mg) of GSK716155 to abdomen.
Group B	GSK716155 subcutaneous injections	In Group B healthy subjects will be randomized to receive 64 mg of GSK716155 to abdomen.
Group C	GSK716155 subcutaneous injections	In Group C Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to abdomen.
Group D	GSK716155 subcutaneous injections	In Group D Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to arm.
Group E	GSK716155 subcutaneous injections	In Group E Type II diabetes subjects will be randomized to receive 16 mg of GSK716155 to leg.
Group F	GSK716155 subcutaneous injections	In Group F Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to abdomen.
Group G	GSK716155 subcutaneous injections	In Group G Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to arm.
Group H	GSK716155 subcutaneous injections	In Group H Type II diabetes subjects will be randomized to receive 64 mg of GSK716155 to leg.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Pharmacodynamic measurements at three different times after one dose.	Up to Day 29

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 San Antonio, Texas, United States