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

NCT ID: NCT00575159

Last Updated: 2017-10-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-12-18

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 1

Keywords

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type 1 Diabetes mellitus, pharmacokinetics, pharmacodynamics Adult male and females,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm a

GSK189075

Group Type EXPERIMENTAL

GSK189075

Intervention Type DRUG

investigational drug

Arm b

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo comparator

Interventions

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GSK189075

investigational drug

Intervention Type DRUG

placebo

placebo comparator

Intervention Type DRUG

Other Intervention Names

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GSK189075

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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

San Diego, California, United States

Site Status

Countries

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Germany United States

References

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Mudaliar S, Armstrong DA, Mavian AA, O'Connor-Semmes R, Mydlow PK, Ye J, Hussey EK, Nunez DJ, Henry RR, Dobbins RL. Remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2, improves serum glucose profiles in type 1 diabetes. Diabetes Care. 2012 Nov;35(11):2198-200. doi: 10.2337/dc12-0508. Epub 2012 Sep 25.

Reference Type DERIVED
PMID: 23011728 (View on PubMed)

Other Identifiers

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KGI107465

Identifier Type: -

Identifier Source: org_study_id