A Study to Assess the Safety of Single Doses of GSK189075 in Subjects With Type 1 Diabetes Mellitus

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: placebo; Drug: GSK189075

Study type: Interventional

Funder types: Industry

Identifiers

NCT00575159

KGI107465

Details and patient eligibility

About

The purpose of this research study is to look at concentrations of GSK189075 in blood when single doses of the drug are taken by mouth in combination with basal insulin. The clinical effects of the drug in combination with insulin on the body will also be studied. The results will help determine doses of GSK189075 can be studied in the future in the type I diabetes mellitus population.

Enrollment: 10 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male/female, 18 to 55 years old
• Diagnosis of type 1 diabetes mellitus for at least 6 months; and using a continuous insulin pump
• Willing and able to follow all study-related instructions provided by the site staff.
• Willing to provide signed informed consent.

Exclusion criteria

• Pregnant or a nursing female.
• Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
• Have HIV or hepatitis, or have alcohol or drugs in your system at the screening visit.
• Have a history of alcohol abuse or have an eating disorder
• Have been in another research study in the last month or have taken certain medications in the 1 week before study drug would be taken.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Arm a

Experimental group

Description:

GSK189075

Treatment:

Drug: GSK189075

Arm b

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo