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In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GSK716155 subcutaneous injections
placebo injection
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring GSK716155, albiglutide, pharmacodynamics, pharmacokinetics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months. Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea. Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study. Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg. Women must be of non-childbearing potential. Exclusion criteria: Laboratory values that meet certain criteria (for example, total cholesterol > 240 mg/dL). Clinically significant hepatic enzyme elevation. Fasting plasma glucose greater than 240mg/dL. 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 during the study. Unwilling to abstain from caffeine- or xanthine-containing products during the study. 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. Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

albiglutide

albiglutide placebo

Arm Description

albiglutide injection

placebo injection

Outcomes

Primary Outcome Measures

blood plasma levels of GSK716155

Secondary Outcome Measures

blood plasma levels of GSK716155

Full Information

First Posted
July 18, 2006
Last Updated
October 24, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00354536
Brief Title
In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
Official Title
A Single-blinded Randomized, Placebo-controlled, Staggered-parallel, Escalating-dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Injections of GSK 716155 in Subjects With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream when it is given at the same dose 7 days apart, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
GSK716155, albiglutide, pharmacodynamics, pharmacokinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
albiglutide
Arm Type
Active Comparator
Arm Description
albiglutide injection
Arm Title
albiglutide placebo
Arm Type
Placebo Comparator
Arm Description
placebo injection
Intervention Type
Drug
Intervention Name(s)
GSK716155 subcutaneous injections
Intervention Description
albiglutide subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
placebo injection
Other Intervention Name(s)
placebo
Intervention Description
placebo injection
Primary Outcome Measure Information:
Title
blood plasma levels of GSK716155
Time Frame
on days 2 & 9
Secondary Outcome Measure Information:
Title
blood plasma levels of GSK716155
Time Frame
on days 2 & 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Subjects must have type 2 diabetes mellitus that has been diagnosed for at least three months. Must be taking either (1) no medication for their diabetes or (2) taking metformin, a sulfonylurea, or metformin and a sulfonylurea. Subjects must be willing to wash-out of these medications for 14 days prior to the start of the study. Subjects must have a BMII between 25 and 40 kg/m² and weigh at leas 50kg. Women must be of non-childbearing potential. Exclusion criteria: Laboratory values that meet certain criteria (for example, total cholesterol > 240 mg/dL). Clinically significant hepatic enzyme elevation. Fasting plasma glucose greater than 240mg/dL. 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 during the study. Unwilling to abstain from caffeine- or xanthine-containing products during the study. 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. Previously received any GLP-1 mimetic that has moe than 70% sequence homology to GLP-1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Miramar
State/Province
Florida
ZIP/Postal Code
33025
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
GSK Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814-4224
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25387217
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
GLP106073
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
GLP106073
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
GLP106073
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
GLP106073
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
GLP106073
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
GLP106073
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
GLP106073
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus

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