Study Stopped
Company decision not related to safety.
A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus
A Randomized, Double-blind, Parallel, Placebo-Controlled, Study to Evaluate the Safety and Tolerability of Oral GW677954 Capsules (15 mg) in Combination With Insulin in Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes-mellitus
Started Sep 2006
Shorter than P25 for phase_2 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedJune 4, 2012
May 1, 2011
2 months
February 16, 2007
May 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight
up to 24 weeks
Secondary Outcomes (1)
safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference
up to 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Beverly Hills, California, 90211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
September 1, 2006
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
June 4, 2012
Record last verified: 2011-05