Overview

A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus

Status:
Terminated
Trial end date:
2006-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Insulin
Insulin, Globin Zinc
Criteria
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