A Phase 1 Study to Evaluate the Effect of GSK256073, an HM74A Receptor Agonist, on Glucose and NEFA Levels in Type 2 Diabetics
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.
1 other identifier
interventional
39
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 diabetes-mellitus-type-2
Started Jul 2010
Shorter than P25 for phase_1 diabetes-mellitus-type-2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2010
CompletedFirst Posted
Study publicly available on registry
June 22, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 7, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 7, 2010
CompletedJune 14, 2017
June 1, 2017
2 months
June 17, 2010
June 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weighted mean AUC for glucose
24 hours
Secondary Outcomes (1)
Weighted mean AUC for NEFA, glycerol, triglycerides, insulin, and C-peptide
24 hours
Study Arms (5)
Placebo
PLACEBO COMPARATORSubjects will receive 2 placebo tablets in the morning and 2 placebo tablets in the evening on Day 1 and Day 2.
5mg BID
OTHERSubjects will receive 1 x 5mg tablet and 1 placebo tablet in the morning, and 1 x 5mg tablet and 1 placebo tablet in the evening on Day 1 and Day 2.
10mg QD
OTHERSubjects will receive 2 x 5mg tablets in the morning and 2 placebo tablets in the evening on Day 1 and Day 2.
25mg BID
OTHERSubjects will receive 1 x 25mg tablet and 1 placebo tablet in the morning, and 1 x 25mg tablet and 1 placebo tablet in the evening on Day 1 and Day 2.
50mg QD
OTHERSubjects will receive 2 x 25mg tablets in the morning and 2 placebo tablets in the evening on Day 1 and Day 2.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (4)
GSK Investigational Site
Anniston, Alabama, 36207, United States
GSK Investigational Site
Miami, Florida, 33169, United States
GSK Investigational Site
Miami Gardens, Florida, 33169, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
Related Publications (1)
Dobbins RL, Shearn SP, Byerly RL, Gao FF, Mahar KM, Napolitano A, Nachbaur GJ, Le Monnier de Gouville AC. 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 Nov;15(11):1013-21. doi: 10.1111/dom.12132. Epub 2013 Jun 12.
PMID: 23701262BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2010
First Posted
June 22, 2010
Study Start
July 1, 2010
Primary Completion
September 7, 2010
Study Completion
September 7, 2010
Last Updated
June 14, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.