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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014