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

NCT00394030 | Completed Phase 1

• 1 other identifier: GLP107724
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

GSK716155 pharmacodynamics pharmacokinetics injection site

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic measurements for different injection sites after one dose.

  Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours

Secondary Outcomes (1)

• Pharmacodynamic measurements at three different times after one dose.

  Up to Day 29

Study Arms (8)

Group A

EXPERIMENTAL

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

Drug: GSK716155 subcutaneous injections

Group B

EXPERIMENTAL

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

Drug: GSK716155 subcutaneous injections

Group C

EXPERIMENTAL

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

Drug: GSK716155 subcutaneous injections

Group D

EXPERIMENTAL

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

Drug: GSK716155 subcutaneous injections

Group E

EXPERIMENTAL

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

Drug: GSK716155 subcutaneous injections

Group F

EXPERIMENTAL

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

Drug: GSK716155 subcutaneous injections

Group G

EXPERIMENTAL

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

Drug: GSK716155 subcutaneous injections

Group H

EXPERIMENTAL

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

Drug: GSK716155 subcutaneous injections

Interventions

GSK716155 subcutaneous injections DRUG

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.

Group A; Group B; Group C; Group D; Group E; Group F; Group G; Group H

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (6)

GSK Investigational Site

Long Beach, California, 90806, United States

Location

GSK Investigational Site

Walnut Creek, California, 94598, United States

Location

GSK Investigational Site

Miramar, Florida, 33025, United States

Location

GSK Investigational Site

Orlando, Florida, 32809, United States

Location

GSK Investigational Site

Morrisville, North Carolina, 27560, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Young MA, Wald JA, Matthews JE, Scott R, Hodge RJ, Zhi H, Reinhardt RR. Clinical pharmacology of albiglutide, a GLP-1 receptor agonist. Postgrad Med. 2014 Nov;126(7):84-97. doi: 10.3810/pgm.2014.11.2836.

  PMID: 25387217 DERIVED

Related Links

• Results for study GLP107724 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2006
• First Posted: October 31, 2006
• Study Start: October 16, 2006
• Primary Completion: March 20, 2007
• Study Completion: March 20, 2007
• Last Updated: September 11, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

US (6)