Status:
TERMINATED
A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus
Lead Sponsor:
GlaxoSmithKline
Conditions:
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-65 years
Phase:
PHASE2
Brief Summary
Many drugs used for the treatment of Type 2 Diabetes Mellitus cause the body to retain water. This study will assess whether or not GW677954 causes the body to retain fluid.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Have been diagnosed by a doctor with Type 2 Diabetes Mellitus at least 3 months before Screening
- Have a body mass index within range 25 to 40.0kg/m2 inclusive
- Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition)
- Exclusion criteria:
- Significant weight loss or gain in the 3 months before screening
- Have used insulin to treat hyperglycemia within 3 months before screening
- Have a history of fluid retention
- Have uncontrolled high blood pressure
- Have liver disease
- Take loop diuretics (water pills), certain blood thinners, and/or St. Johns Wort. - Have or have had certain kinds of cancer
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00437164
Start Date
September 1 2006
End Date
November 1 2006
Last Update
June 4 2012
Active Locations (1)
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1
GSK Investigational Site
Beverly Hills, California, United States, 90211