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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
History of Changes
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Diabetes Mellitus, Type 2
 Drug: Insulin
Drug: Oral GW677954 Capsules (15 mg)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: September 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Insulin Drug: Oral GW677954 Capsules (15 mg)
    Other Names:
    • Oral GW677954 Capsules (15 mg)
    • Insulin
  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437164

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00437164     History of Changes
Other Study ID Numbers: ADG106149
Study First Received: February 16, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
NaBr
Sodium Bromide
DEXA Deuterium
Total Body Water
Insulin
 D2O
GW677954
Randomized Withdrawal
T2DM

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

ClinicalTrials.gov processed this record on June 18, 2013