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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

Tracking Information
First Submitted Date  ICMJE September 14, 2007
First Posted Date  ICMJE September 17, 2007
Last Update Posted Date August 17, 2017
Actual Study Start Date  ICMJE August 1, 2007
Actual Primary Completion Date April 17, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
Plasma concentrations and PD parameters over time and at the end of study [ Time Frame: Up to Week 9 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
Plasma concentrations and PD parameters over time and at the end of study
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
Other metabolic parameters at the end of study [ Time Frame: Up to Week 9 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2007)
Other metabolic parameters at the end of study
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Assessment of GSK716155 for Type 2 Diabetes Mellitus
Official Title  ICMJE 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
Brief Summary A Phase I/II study to investigate the safety, pharmacokinetics and pharmacodynamics of GSK716155 in Japanese subjects with type 2 diabetes mellitus
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: GSK716155 for injection
  • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2007)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 17, 2008
Actual Primary Completion Date April 17, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00530309
Other Study ID Numbers  ICMJE GLP107865
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP