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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00437164

Enrollment

Registered

2007-02-19

Start date

2006-09-30

Completion date

2006-11-30

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus

Keywords

NaBr, Sodium Bromide, DEXA Deuterium, Total Body Water, Insulin, D2O, GW677954, Randomized Withdrawal, T2DM

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.

Interventions

DRUGInsulin

DRUGOral GW677954 Capsules (15 mg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight	up to 24 weeks

Secondary

Measure	Time frame
safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference	up to 24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026