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Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00530309
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: GSK716155 for injection Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus -A Phase I/II Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of GSK716155 in Japanese Subjects With Type 2 Diabetes Mellitus
Actual Study Start Date : August 1, 2007
Primary Completion Date : April 17, 2008
Study Completion Date : April 17, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Subjects receiving GSK716155 + placebo
Eligible subjects will receive GSK716155 with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks. Subjects will also receive placebo.
Drug: GSK716155 for injection
GSK716155 will be available with doses of 15 milligrams once a week, 30 milligrams once a week, 50 milligrams biweekly or 100 milligrams once every four weeks.
Drug: Placebo
Subjects will also receive placebo.



Primary Outcome Measures :
  1. Plasma concentrations and PD parameters over time and at the end of study [ Time Frame: Up to Week 9 ]

Secondary Outcome Measures :
  1. Other metabolic parameters at the end of study [ Time Frame: Up to Week 9 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Type 2 diabetes mellitus diagnosed at least 3 months with FPG level <=240mg/dL and HbA1c between 6.5% and 10% inclusive.
  • Must be diet controlled - OR - taking a single oral antidiabetic agent (other than thiazolidinediones) and willing to withdraw from this treatment from 2 weeks prior to the study.
  • Must have a BMI:<=35kg/m2, 20 to 70 years of age inclusive.
  • Woman must be of non-childbearing potential.

Exclusion criteria:

  • Positive test result for either syphilis, HBs antigen, HCV antibody, HIV antigen/antibody, or HTLV-1 antibody.
  • Clinically significant hepatic enzyme elevation.
  • History of metabolic disease other than T2DM.
  • Previous use of insulin as a treatment for diabetes within 3 months.
  • History of severe gastrointestinal disease.
  • Clinically significant cardiovascular disease.
  • Significant renal disease as defined by screening lab test.
  • History of drug (including albumin or albumin containing agents) allergy.
  • History of alcohol or drug abuse.
  • Donation of blood in excess of 400mL within previous 4 months.
  • Previously received any GLP-1 mimetic or any other albumin-containing products.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530309


Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 812-0025
GSK Investigational Site
Tokyo, Japan, 130-0004
GSK Investigational Site
Tokyo, Japan, 160-0017
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: GLP107865
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: GLP107865
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: GLP107865
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: GLP107865
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: GLP107865
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: GLP107865
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: GLP107865
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00530309     History of Changes
Other Study ID Numbers: GLP107865
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: August 17, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: http://

Keywords provided by GlaxoSmithKline:
GLP-1
type 2 diabeted mellitus
safety
GSK716155
GLP-1 receptor agonist
tolerability
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases