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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00437164
Recruitment Status : Terminated (Company decision not related to safety.)
First Posted : February 19, 2007
Last Update Posted : June 4, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Drug: Insulin Drug: Oral GW677954 Capsules (15 mg) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Insulin
  • Drug: Oral GW677954 Capsules (15 mg)
    Other Name: Insulin

Primary Outcome Measures :
  1. changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight [ Time Frame: up to 24 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00437164

United States, California
GSK Investigational Site
Beverly Hills, California, United States, 90211
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline Identifier: NCT00437164     History of Changes
Other Study ID Numbers: ADG106149
First Posted: February 19, 2007    Key Record Dates
Last Update Posted: June 4, 2012
Last Verified: May 2011

Keywords provided by GlaxoSmithKline:
Sodium Bromide
DEXA Deuterium
Total Body Water
Randomized Withdrawal

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs