Last updated: 11/04/2018 04:33:24

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

GSK study ID
ADG106149
Clinicaltrials.gov ID
NCT00437164
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight

Timeframe: up to 24 weeks

Secondary outcomes:

safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference

Timeframe: up to 24 weeks

Interventions:
Drug: Insulin
Drug: Oral GW677954 Capsules (15 mg)
Enrollment:
1
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Type 2 Diabetes Mellitus
Product
sodelglitazar
Collaborators
Not applicable
Study date(s)
September 2006 to November 2006
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
30 - 65 years
Accepts healthy volunteers
No
  • 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
  • Significant weight loss or gain in the 3 months before screening
  • Have used insulin to treat hyperglycemia within 3 months before screening
Inclusion and exclusion 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

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Beverly Hills, California, United States, 90211
Status
Terminated/Withdrawn
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Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2006-10-11

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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