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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: GSK716155 subcutaneous injections

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • GSK Investigational Site
    • Walnut Creek, California, United States, 94598
      • GSK Investigational Site
  • Florida
    • Miramar, Florida, United States, 33025
      • GSK Investigational Site
    • Orlando, Florida, United States, 32809
      • GSK Investigational Site
  • North Carolina
    • Morrisville, North Carolina, United States, 27560
      • GSK Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

8

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 16, 2006
• Primary Completion (ACTUAL): March 20, 2007
• Study Completion (ACTUAL): March 20, 2007

Study Registration Dates

• First Submitted: October 27, 2006
• First Submitted That Met QC Criteria: October 27, 2006
• First Posted (ESTIMATE): October 31, 2006

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 8, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: GSK716155 pharmacodynamics pharmacokinetics injection site
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GLP107724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: GLP107724
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: GLP107724
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: GLP107724
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Annotated Case Report Form
   Information identifier: GLP107724
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: GLP107724
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: GLP107724
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Dataset Specification
   Information identifier: GLP107724
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register