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

This study has been terminated.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00437164

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	Drug: Insulin Drug: Oral GW677954 Capsules (15 mg)	Phase II

MedlinePlus related topics: Diabetes Drinking Water

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety Study
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

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

Secondary Outcome Measures:

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

Estimated Enrollment:	116
Study Start Date:	September 2006

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. Johnâ€™s 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, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ADG106149
Study First Received:	February 16, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00437164
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Randomized Withdrawal
DEXA Deuterium
D2O
Sodium Bromide
NaBr

Total Body Water
T2DM
Insulin
GW677954

Study placed in the following topic categories:

Metabolic Diseases
Bromides
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009