- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00437164
A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus
May 31, 2012 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Beverly Hills, California, United States, 90211
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference
Time Frame: up to 24 weeks
|
up to 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
November 1, 2006
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
February 16, 2007
First Submitted That Met QC Criteria
February 16, 2007
First Posted (Estimate)
February 19, 2007
Study Record Updates
Last Update Posted (Estimate)
June 4, 2012
Last Update Submitted That Met QC Criteria
May 31, 2012
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADG106149
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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