Status:
COMPLETED
In-patient Study With GSK716155 In Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
GlaxoSmithKline
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00354536
Start Date
February 1 2006
End Date
September 1 2006
Last Update
October 26 2016
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Miramar, Florida, United States, 33025
2
GSK Investigational Site
Orlando, Florida, United States, 32809
3
GSK Investigational Site
Honolulu, Hawaii, United States, 96814-4224
4
GSK Investigational Site
Portland, Oregon, United States, 97239