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In-patient Study With GSK716155 In Patients With 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: NCT00354536
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE July 18, 2006
First Posted Date  ICMJE July 20, 2006
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE February 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2007)
blood plasma levels of GSK716155 [ Time Frame: on days 2 & 9 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2006)
Pharmacodynamic measurements during 7 days of dosing.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2007)
blood plasma levels of GSK716155 [ Time Frame: on days 2 & 9 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2006)
Pharmacokinetic measurements during 7 days of dosing.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: GSK716155 subcutaneous injections
    albiglutide subcutaneous injection
  • Biological: placebo injection
    placebo injection
    Other Name: placebo
Study Arms  ICMJE
  • Active Comparator: albiglutide
    albiglutide injection
    Intervention: Drug: GSK716155 subcutaneous injections
  • Placebo Comparator: albiglutide placebo
    placebo injection
    Intervention: Biological: placebo injection
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. Review.

*   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: July 18, 2006)
60
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00354536
Other Study ID Numbers  ICMJE GLP106073
Has Data Monitoring Committee Not Provided
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 October 2016

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