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

NCT ID: NCT00437164

Last Updated: 2012-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Insulin

Intervention Type DRUG

Oral GW677954 Capsules (15 mg)

Intervention Type DRUG

Other Intervention Names

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Insulin

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Beverly Hills, California, United States

Site Status

Countries

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United States

Other Identifiers

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ADG106149

Identifier Type: -

Identifier Source: org_study_id

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