Status:
COMPLETED
A Phase 1 Study to Evaluate the Effect of GSK256073, an HM74A Receptor Agonist, on Glucose and NEFA Levels in Type 2 Diabetics
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
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...
Detailed Description
This is a multi-center study that will enroll approximately 36 subjects. The study consists of three periods of two days of dosing each. The study will evaluate 5 potential dose regimens. Each subject...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2010
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01147861
Start Date
July 1 2010
End Date
September 7 2010
Last Update
June 14 2017
Active Locations (4)
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1
GSK Investigational Site
Anniston, Alabama, United States, 36207
2
GSK Investigational Site
Miami, Florida, United States, 33169
3
GSK Investigational Site
Miami Gardens, Florida, United States, 33169
4
GSK Investigational Site
San Antonio, Texas, United States, 78229