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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00437164
• Other study ID #: ADG106149
• Status: Terminated
• Phase: Phase 2
• First received: February 16, 2007
• Last updated: May 31, 2012
• Start date: September 2006
• Est. completion date: November 2006

Study information

• Verified date: May 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin

• Oral GW677954 Capsules (15 mg)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Beverly Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in fluid related parameters as measured by hematocrit and hemoglobin levels and body weight		up to 24 weeks	No
Secondary	safety/tolerability, as measured by adverse events, clinical laboratory, edema & glycemic measures, ophthalmic assessments; & changes in weight, waist & hip circumference		up to 24 weeks	No