Last updated: 11/04/2018 08:32:02

A study to assess the safety of single doses of GSK189075 in subjects with type 1 diabetes mellitus

GSK study ID
KGI107465
Clinicaltrials.gov ID
NCT00575159
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A double-blind, randomized, single ascending dose escalation, placebo-controlled, crossover study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK189075 administered to subjects with type 1 diabetes mellitus
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of participants with all adverse events (AE) and serious adverse events (SAE)

Timeframe: Up to 6 months

Number of participants with hypoglycemia episodes/events

Timeframe: Day 1 of each treatment period

Change from Baseline Vital Signs: Systolic and Diastolic blood pressure (SBP and DBP)

Timeframe: Day 1 of each treatment period

Change from Baseline Vital Signs: Heart rate

Timeframe: Day 1 of each treatment period

Number of participants with abnormal Electrocardiogram (ECG) findings

Timeframe: Day 1 of each treatment period

Number of participants with abnormal clinical chemistry data

Timeframe: Day 1 of each treatment period

Number of participants with abnormal Hematology data

Timeframe: Day 1 of each treatment period

Summary of urine osmolality

Timeframe: Day 1 (pre dose) of each treatment period

Mean creatinine clearance

Timeframe: Up to 24 hours post dose of each treatment period.

Summary of Fluid Balance

Timeframe: Up to 24 hours post dose of each treatment period.

Mean of derived plasma glucose parameters

Timeframe: Up to 24 hours post dose of each treatment period.

Secondary outcomes:

Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1

Timeframe: Up to 24 hours post dose of each treatment period.

Urinary glucose excretion (UGE) for timed subintervals up to 24 hours post dose (0-24 H)

Timeframe: Up to 24 hours post dose of each treatment period

Percent of filtered glucose in the urine.

Timeframe: Up to 24 hours post dose of each treatment period.

Mean total Urine volume 0-24 H

Timeframe: Day 1 of each treatment period

Mean creatinine clearance 0-24 H

Timeframe: Day 1 of each treatment period

Area under the plasma concentration vs. time curve (AUC) from time zero (time of dosing) to the last time point with measurable analyte concentration, AUC(0-last), AUC from time zero to infinite time, AUC(0-inf) of GSK189075 over period

Timeframe: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period

maximum observed plasma concentration (Cmax) of GSK189075 over period

Timeframe: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period

Time to maximum observed plasma concentration (Tmax) and terminal half life, (T1/2) of GSK189075 over period

Timeframe: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period

AUC from time zero to 4 hours post dose, AUC(0-4) for GSK189074 over period

Timeframe: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period

Oral clearance (CL/F) over period

Timeframe: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period

The metabolite to parent AUC ratio, AUCmetabolite/AUCparent ratio for GSK189074 over period

Timeframe: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period

The metabolite to parent AUC ratio, AUCmetabolite/AUCparent ratio for GSK279782 over period

Timeframe: Pre-dose, 0.25 h, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4 h, 6 h, 8 h, 12 h, and 16 h of each treatment period

Interventions:
  • Drug: GSK189075
  • Drug: placebo
    • Enrollment:
    10
    Primary completion date:
    2008-18-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Diabetes Mellitus, Type 1
    Product
    remogliflozin etabonate
    Collaborators
    Not applicable
    Study date(s)
    March 2008 to December 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 55 years
    Accepts healthy volunteers
    No
    • 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
    • Pregnant or a nursing female.
    • Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
    Inclusion and exclusion criteria
    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 location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    San Diego, California, United States, 92161
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2008-18-12
    Actual study completion date
    2008-18-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website