Last updated: 11/07/2018 07:29:16

A phase 1 study to evaluate the effect of GSK256073, an HM74A receptor agonist, on glucose and NEFA levels in Type 2 diabetics

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GSK study ID
114187
See study documents
Clinicaltrials.gov ID
NCT01147861
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomized, single blind, placebo-controlled, three period crossover, dose selection study to evaluate the effect of GSK256073, an HM74A receptor agonist, on glucose and NEFA 24 hour profile in type 2 diabetic patients.
Trial description: The aim of this study is to verify whether a significant decrease in glucose levels can be achieved with the HM74A agonist GSK256073 in type 2 diabetic patients. Several dose levels and a placebo will be evaluated in a three period crossover study with two active doses and one placebo dose per subject, in order to determine whether there is a dose that produces glucose lowering in the target population. In addition, this study will investigate the optimal dosing regimen for full manifestation of any metabolic effect of GSK256073 by comparing once a day versus twice a day regimens.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Weighted mean AUC for glucose

Timeframe: 24 hours

Secondary outcomes:

Weighted mean AUC for NEFA, glycerol, triglycerides, insulin, and C-peptide

Timeframe: 24 hours

Interventions:
  • Drug: GSK256073
  • Other: Placebo
    • Enrollment:
    39
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Anne-charlotte Le Monnier De Gouville, Shawn P. Shearn, Robert L.Byerly, Feng F. Gao, Kelly M. Mahar, Antonella Napolitano, Gaelle J. Nachbaur, Robert L. Dobbins. GSK256073, A Selective Agonist of G-protein Coupled Receptor 109A (GPR109A) Reduces Serum Glucose in Subjects with Type 2 Diabetes Mellitus. Diabetes Obes Metab. 2013;ePub ahead of print lication:
    Anne-charlotte Le Monnier De Gouville, Shawn P. Shearn, Robert L.Byerly, Feng F. Gao, Kelly M. Mahar, Antonella Napolitano, Gaelle J. Nachbaur, Robert L. Dobbins. GSK256073, A Selective Agonist of G-protein Coupled Receptor 109A (GPR109A) Reduces Serum Glucose in Subjects with Type 2 Diabetes Mellitus. Diabetes Obes Metab. 2013;15(11):1013-21
    Medical condition
    Diabetes Mellitus, Type 2
    Product
    GSK256073
    Collaborators
    Not applicable
    Study date(s)
    July 2010 to September 2010
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    20 - 70 years
    Accepts healthy volunteers
    No
    • Subjects with documented (not less than 6 months prior to screening) type 2 diabetes mellitus diagnosis with:
    • HbA1c levels greater than 6.5 percent and less than or equal to 9.5 percent at screening,
    • A subject will not eligible for inclusion in this study if any of the following criteria apply:
    • Requiring insulin therapy or use of combination oral antidiabetic medications or use of monotherapy other than metformin within the 3 months prior to screening
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subjects with documented (not less than 6 months prior to screening) type 2 diabetes mellitus diagnosis with:
    • HbA1c levels greater than 6.5 percent and less than or equal to 9.5 percent at screening,
    • On monotherapy with metformin at the time of screening, and at a todal daily dose greater than or equal to 1000 mg at the time of dosing,
    • Fasting plasma glucose level less than 270 mg/dl at screening
    • Male or female between 20 and 70 years of age inclusive, at the time of signing the informed consent
    • Waist circumference above 102cm (40 inches) for men, and 88cm (35 inches) for women
    • Fasting triglycerides between 150 mg/dl and 500 mg/dl, inclusive
    • BMI within the range of 22-37 kg/meter squared, inclusive
    Exclusion criteria:
    • A subject will not eligible for inclusion in this study if any of the following criteria apply:
    • Requiring insulin therapy or use of combination oral antidiabetic medications or use of monotherapy other than metformin within the 3 months prior to screening
    • Past or present disease (other than type 2 diabetes mellitus) that in the opinion of the Investigator may affect the outcome of this study. These diseases include the following but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, gastrointestinal disease and endocrine disease
    • A positive pre-study Hepatitis B surface antigen, or positive Hepatitis C or HIV antibody result within 3 months of screening
    • Renal impairment as defined by a calculated GFR less than 60 ml/min
    • Any concurrent serious illness (e.g., severe COPD, history of malignancy other than skin cancer within 5 years of initial diagnosis or with evidence of recurrence) that may interfere with a subject completing the study
    • Clinical laboratory values as defined per protocol
    • ECG parameters as defined per protocol
    • History of gout and/or hyperuricemia/uric acid kidney stone or treated with drugs for hyperuricemia: allopurinol and/or probenecid
    • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
    • Use of the following blood pressure medications or other medications renally excreted via OAT is prohibited: Enalapril (at any dose), Losartan (at any dose), Captopril (at any dose)
    • Pregnant females as determined by positive serum hCG test at screening or positive urine hCG test prior to dosing
    • Lactating females

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Anniston, Alabama, United States, 36207
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33169
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Miami Gardens, Florida, United States, 33169
    Status
    Terminated/Withdrawn
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2010-07-09

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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    Additional information
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