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

This study has been terminated.
(Company decision not related to safety.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00437164
First received: February 16, 2007
Last updated: May 31, 2012
Last verified: May 2011

February 16, 2007
May 31, 2012
September 2006
November 2006   (final data collection date for primary outcome measure)
changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight
Complete list of historical versions of study NCT00437164 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Type 2 Diabetes Mellitus
  • Diabetes Mellitus, Type 2
  • Drug: Insulin
  • Drug: Oral GW677954 Capsules (15 mg)
    Other Names:
    • Oral GW677954 Capsules (15 mg)
    • Insulin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
November 2006
November 2006   (final data collection date for primary outcome measure)

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
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00437164
ADG106149
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP