Back to resultsA Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Insulin
Oral GW677954 Capsules (15 mg)
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring NaBr, Sodium Bromide, DEXA Deuterium, Total Body Water, Insulin, D2O, GW677954, Randomized Withdrawal, T2DM
Eligibility 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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight
Secondary Outcome Measures
safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00437164
Brief Title
A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Terminated
Why Stopped
Company decision not related to safety.
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
Keywords
NaBr, Sodium Bromide, DEXA Deuterium, Total Body Water, Insulin, D2O, GW677954, Randomized Withdrawal, T2DM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin
Intervention Type
Drug
Intervention Name(s)
Oral GW677954 Capsules (15 mg)
Other Intervention Name(s)
Insulin
Primary Outcome Measure Information:
Title
changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
12. IPD Sharing Statement
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A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus
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