Diabetes Mellitus, Type 1Phase 2NCT00575159

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

A Phase 2 study testing GSK189075 in people with Diabetes Mellitus, Type 1, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Diabetes Mellitus, Type 1
What is being tested?: GSK189075
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 31 Mar 2008to 18 Dec 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
San Diego, California, 92161

Other trials in United States

About this study

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

Conditions: Diabetes Mellitus, Type 1
Being tested: GSK189075, placebo
Keywords: type 1 Diabetes mellitus, pharmacokinetics,, pharmacodynamics, Adult male and females,
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK189075Drug
investigational drug
placeboDrug
Also called GSK189075
placebo comparator

Study groups in NCT00575159
Study group	Role	What they receive
Arm a	Experimental	GSK189075 Receives: Drug: GSK189075
Arm b	Placebo comparator	Placebo Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Measured: Up to 6 months
Number of Participants With Hypoglycemia Episodes/Events
A hypoglycemic event was defined as symptoms of hypoglycemia confirmed by a blood glucose value below normal limits [less than 3.89 millimoles per liter (mmol/L)] or 70 milligrams per deciliter (mg/dL). Symptoms of hypoglycemia without confirmed blood glucose values were reported as AEs instead of hypoglycemic events. Number of participants with hypoglycemic events were reported.
Measured: Day 1 of each treatment period
Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP)
SBP and DBP were obtained during each treatment period at the indicated time points. Measurements were made with the participant lying semi-recumbent having rested in this position for at least 10 minute before the initial reading.
Measured: Day 1 of each treatment period
Change From Baseline Vital Signs: Heart Rate
Heart rate was obtained during each treatment period at indicated time points. Measurements were made with the participants lying semi-recumbent having rested in this position for at least 10 minutes before the initial reading.
Measured: Day 1 of each treatment period
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Standard semi-recumbent 12-lead ECG was obtained after the participant rested for a minimum of 10 minutes (If questionable abnormality was noted on the ECG, 2 more measurements were allowed to provide an average of 3 measurements). Number of participants with abnormal ECG were reported.
Measured: Day 1 of each treatment period
Number of Participants With Abnormal Clinical Chemistry Data
Clinical Chemistry data for parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Bicarbonate, Calcium, Chloride, Creatine Kinase, Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Lactate Dehydrogenase, Magnesium, Phosphorus, Potassium, Total Bilirubin, Sodium, Total protein, triglycerides and urea/BUN was reported. Data for number of participants with abnormal clinical Chemistry data was presented.
Measured: Day 1 of each treatment period
Number of Participants With Abnormal Hematology Data
Data for abnormal Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red Blood Cell (RBC), Reticulocytes, Total Neutrophils, White Blood Cell (WBC) were reported. Data for number of participants with abnormal Hematology were reported.
Measured: Day 1 of each treatment period
Summary of Urine Osmolality
Urine sample was collected at screening, Day -2 (18:00h) and Day 1 (7:45h) for determination of urine osmolality which was measured in Millimole per kilogram (mmol/kg).
Measured: Day 1 (pre dose) of each treatment period
Mean Creatinine Clearance
Creatinine clearance was calculated and reported in Milliliters per minute (mL/min) on Day 1 of each period for each collection interval 0-4, 4-8, 8-12, 12-16 and 16-24 hour, as well as the combined intervals of 0-12 and 0-24 hour. For urine measurements, participants were instructed to void within 30 minutes before administration of study medication.
Measured: Up to 24 hours post dose of each treatment period.
Summary of Fluid Balance
On Day 1, fluid intake, urine volume and number of micturations were recorded over the intervals for each of the following dosing periods: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. From these measures, fluid balance was calculated over the 24-hour period. Fluid Balance=total fluid intake minus total urine volume. The 0-24h amounts of total Fluid Intake, total urine output, and fluid balance were calculated by adding the amounts collected during these time intervals.
Measured: Up to 24 hours post dose of each treatment period.
Mean of Derived Plasma Glucose Parameters
The plasma measurements at specified time points on Day 1 were collected. Derived plasma glucose parameters were presented.
Measured: Up to 24 hours post dose of each treatment period.

Secondary outcomes (12)

Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1
AUC(0-10) was the plasma glucose weighted mean AUC for 0 to 10 h post-dosing and AUC(0-4) was the plasma glucose weighted mean AUC for 0 to 4 h post-dosing. Incremental Adjusted Weighted Means were presented.
Measured: 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)
UGE was assessed for timed subintervals up to 24h post-dose. Urine samples were collected at intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h on study days. The 0-24h amounts excreted in urine were calculated by adding the amounts collected during these time intervals.
Measured: Up to 24 hours post dose of each treatment period
Percent of Filtered Glucose in the Urine.
Filtered glucose in the urine was assessed at indicated time points and was presented as Percentage. The 0-12h and 0-24h amounts Percent of filtered glucose in the urine were calculated by adding the amounts collected during these time intervals.
Measured: Up to 24 hours post dose of each treatment period.
Mean Total Urine Volume 0-24 H
Urine volume was recorded over intervals : 0-4h, 4-8h, 8-12h, 12-16h and 16- 24h on Day 1 for each dosing period. Mean total Urine volume over 24 hours was presented.
Measured: Day 1 of each treatment period
Mean Creatinine Clearance 0-24 H
Urine samples for calculating creatinine clearance were obtained over the intervals: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. Mean creatinine clearance over 0-24 H was presented.
Measured: 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
AUC(0-last) was defined as area under the plasma concentration vs. time curve from time zero (time of dosing) to the last time point with measurable analyte concentration and AUC(0-inf) was defined as area under the plasma concentration vs. time curve from time zero to infinite time. Blood samples were collected on time points: 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.
Measured: 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
Plasma samples for pharmacokinetic analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Geometric Means with respective Geometric Coefficient of Variation (% CV).
Measured: 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
Tmax was defined as the time to the maximum or "peak" concentration of a drug observed after multiple administration. T1/2 was defined as the time to when half of the total amount of a particular substance is eliminated from the body. Blood samples obtained during indicated time points. T1/2 was calculated as t1/2 = ln2/λz, with λz (the terminal elimination rate-constant) estimated from log-linear regression analysis of the terminal phase of the plasma concentration-time profile.Tmax and t1/2 values for GSK189075 were presented.
Measured: 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
AUC(0-4) was defined as AUC from time zero to 4 hours post dose. Blood samples were collected on time points: 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.
Measured: 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
Oral clearance is a measure of the rate at which the drug is cleared from the body via metabolism. Blood samples were collected on time points: 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
Measured: 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
Blood samples were collected on time points: 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 to obtain the metabolite to parent AUC ratio for GSK189074
Measured: 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
Blood samples were collected on time points: 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 to obtain the metabolite to parent AUC ratio for GSK279782
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 200818 Dec 2008

First posted18 Dec 2007 (estimated)
Study start31 Mar 2008
Primary completion18 Dec 2008
Study completion18 Dec 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00575159
Sponsor's protocol ID: KGI107465
Status last verified: Aug 2017
First submitted: 14 Dec 2007
Last updated: 9 Oct 2017
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 23011728

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00575159
Acronym / sponsor ID: KGI107465
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 Diabetes mellitus, pharmacokinetics,, pharmacodynamics, Adult male and females,
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 31 Mar 2008 (actual)
Primary completion: 18 Dec 2008 (actual)
Study completion: 18 Dec 2008 (actual)
First posted: 18 Dec 2007 (estimated)
Results: Posted 9 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm a	Experimental	Drug: GSK189075GSK189075
Arm b	Placebo comparator	Drug: placeboPlacebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK189075investigational drug	Drug	Arm a
placeboAlso: GSK189075placebo comparator	Drug	Arm b

Primary outcome

Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: Up to 6 months
Data for number of participants who presented one or more adverse events (serious or non serious) was reported. An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Number of Participants With Hypoglycemia Episodes/Events
Time frame: Day 1 of each treatment period
A hypoglycemic event was defined as symptoms of hypoglycemia confirmed by a blood glucose value below normal limits [less than 3.89 millimoles per liter (mmol/L)] or 70 milligrams per deciliter (mg/dL). Symptoms of hypoglycemia without confirmed blood glucose values were reported as AEs instead of hypoglycemic events. Number of participants with hypoglycemic events were reported.
Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP)
Time frame: Day 1 of each treatment period
SBP and DBP were obtained during each treatment period at the indicated time points. Measurements were made with the participant lying semi-recumbent having rested in this position for at least 10 minute before the initial reading.
Change From Baseline Vital Signs: Heart Rate
Time frame: Day 1 of each treatment period
Heart rate was obtained during each treatment period at indicated time points. Measurements were made with the participants lying semi-recumbent having rested in this position for at least 10 minutes before the initial reading.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Time frame: Day 1 of each treatment period
Standard semi-recumbent 12-lead ECG was obtained after the participant rested for a minimum of 10 minutes (If questionable abnormality was noted on the ECG, 2 more measurements were allowed to provide an average of 3 measurements). Number of participants with abnormal ECG were reported.
Number of Participants With Abnormal Clinical Chemistry Data
Time frame: Day 1 of each treatment period
Clinical Chemistry data for parameters: Alanine Amino Transferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Bicarbonate, Calcium, Chloride, Creatine Kinase, Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Lactate Dehydrogenase, Magnesium, Phosphorus, Potassium, Total Bilirubin, Sodium, Total protein, triglycerides and urea/BUN was reported. Data for number of participants with abnormal clinical Chemistry data was presented.
Number of Participants With Abnormal Hematology Data
Time frame: Day 1 of each treatment period
Data for abnormal Hematology parameters: Basophils, Eosinophils, Hematocrit, Hemoglobin, Lymphocytes, Mean Corpuscle Hemoglobin (MCH), Mean Corpuscle Volume (MCV), Monocytes, Platelet count, Red Blood Cell (RBC), Reticulocytes, Total Neutrophils, White Blood Cell (WBC) were reported. Data for number of participants with abnormal Hematology were reported.
Summary of Urine Osmolality
Time frame: Day 1 (pre dose) of each treatment period
Urine sample was collected at screening, Day -2 (18:00h) and Day 1 (7:45h) for determination of urine osmolality which was measured in Millimole per kilogram (mmol/kg).
Mean Creatinine Clearance
Time frame: Up to 24 hours post dose of each treatment period.
Creatinine clearance was calculated and reported in Milliliters per minute (mL/min) on Day 1 of each period for each collection interval 0-4, 4-8, 8-12, 12-16 and 16-24 hour, as well as the combined intervals of 0-12 and 0-24 hour. For urine measurements, participants were instructed to void within 30 minutes before administration of study medication.
Summary of Fluid Balance
Time frame: Up to 24 hours post dose of each treatment period.
On Day 1, fluid intake, urine volume and number of micturations were recorded over the intervals for each of the following dosing periods: 0-4h, 4-8h, 8-12h, 12-16h and 16-24h. From these measures, fluid balance was calculated over the 24-hour period. Fluid Balance=total fluid intake minus total urine volume. The 0-24h amounts of total Fluid Intake, total urine output, and fluid balance were calculated by adding the amounts collected during these time intervals.
Mean of Derived Plasma Glucose Parameters
Time frame: Up to 24 hours post dose of each treatment period.
The plasma measurements at specified time points on Day 1 were collected. Derived plasma glucose parameters were presented.

12 secondary outcomes

Incremental Adjusted Weighted Means of Plasma Glucose AUC(0-4) and AUC(0-10) on Day 1
Time frame: 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)
Time frame: Up to 24 hours post dose of each treatment period
Percent of Filtered Glucose in the Urine.
Time frame: Up to 24 hours post dose of each treatment period.
Mean Total Urine Volume 0-24 H
Time frame: Day 1 of each treatment period
Mean Creatinine Clearance 0-24 H
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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

Results and safety

Results posted to the registry on 9 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Study Arm	10	10

Primary outcome: Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame: Up to 6 months. Count of participants. Unit: Participants

Measure	Placebo n = 10	Placebo+ Prandial Insulin n = 10	GSK189075 50mg n = 10	GSK189075 150mg n = 10	GSK189075 500mg n = 10
Any AE	3	4	5	6	4
Any SAE	0	0	0	0	0

Population analysed: Safety Population comprised of all enrolled participants who have received at least one dose of study drug were included in the safety population.

Primary outcome: Number of Participants With Hypoglycemia Episodes/Events

Time frame: Day 1 of each treatment period. Count of participants. Unit: Participants

Measure	Placebo n = 10	Placebo+ Prandial Insulin n = 10	GSK189075 50mg n = 10	GSK189075 150mg n = 10	GSK189075 500mg n = 10
Value	5	5	3	5	6

Population analysed: Safety Population

Primary outcome: Change From Baseline Vital Signs: Systolic and Diastolic Blood Pressure (SBP and DBP)

Time frame: Day 1 of each treatment period. Mean (Standard Deviation). Unit: Millimeters of mercury (mmHg)

Measure	Placebo n = 10	Placebo+ Prandial Insulin n = 10	GSK189075 50mg n = 10	GSK189075 150mg n = 10	GSK189075 500mg n = 10
SBP,Day1,0.5 H	1.6 (10.63)	-5.1 (5.32)	-0.7 (18.03)	-3.4 (12.97)	-1.9 (8.82)
SBP,Day1,1 H	1.8 (14.70)	-1.7 (9.17)	-4.7 (12.78)	-7.8 (8.77)	5.6 (14.75)
SBP,Day1,2 H	-1.8 (14.01)	-6.5 (6.29)	-5.1 (14.30)	-3.5 (13.19)	-2.2 (9.38)
SBP,Day1,4 H	-2.9 (11.86)	-0.9 (7.56)	-8.4 (8.37)	-2.5 (18.52)	-4.3 (7.49)
SBP,Day1,6 H	-2.1 (9.88)	-5.5 (13.10)	-8.2 (7.18)	-8.4 (15.43)	-6.9 (13.58)
SBP,Day1,8 H	-1.4 (13.12)	-2.1 (10.80)	-3.2 (10.21)	-7.3 (18.50)	-2.4 (12.56)
SBP,Day1,24 H	2.6 (7.27)	-1.4 (11.77)	-0.4 (9.54)	-0.2 (12.20)	-4.6 (12.85)
DBP,Day1,0.5 H	-1.1 (10.36)	-5.3 (9.38)	-9.8 (11.73)	-7.4 (13.13)	-5.2 (13.36)

Population analysed: Safety Population

Primary outcome: Change From Baseline Vital Signs: Heart Rate

Time frame: Day 1 of each treatment period. Mean (Standard Deviation). Unit: beats/minute

Measure	Placebo n = 10	Placebo+ Prandial Insulin n = 10	GSK189075 50mg n = 10	GSK189075 150mg n = 10	GSK189075 500mg n = 10
Day 1,0.5 H	-1.4 (9.69)	-5.4 (8.57)	-4.5 (7.21)	-4.7 (7.58)	-5.2 (12.67)
Day 1,1 H	1.7 (11.46)	-2.8 (8.65)	-1.4 (8.23)	-4.3 (11.20)	-5.1 (12.96)
Day 1,2 H	1.0 (13.79)	-4.0 (7.90)	-4.4 (8.22)	-3.3 (7.42)	-5.1 (14.05)
Day 1,4 H	-1.4 (11.37)	-4.6 (10.46)	-6.5 (7.94)	-2.6 (9.79)	-6.8 (10.90)
Day 1,6 H	2.5 (11.20)	-2.0 (8.46)	-1.3 (10.36)	3.5 (11.54)	-1.4 (12.17)
Day 1,8 H	0.7 (12.48)	-6.6 (10.60)	-4.6 (6.95)	1.6 (10.16)	-3.4 (12.04)
Day 1,24 H	5.4 (13.92)	6.6 (11.67)	4.2 (10.99)	10.0 (11.50)	0.4 (12.39)

Population analysed: Safety Population

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Placebo+ Prandial Insulin	0 of 10 (0%)	4 of 10 (40%)	0 of 10
GSK189075 50mg	0 of 10 (0%)	5 of 10 (50%)	0 of 10
GSK189075 150mg	0 of 10 (0%)	6 of 10 (60%)	0 of 10
GSK189075 500mg	0 of 10 (0%)	4 of 10 (40%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23011728Mudaliar 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK189075 in people with Diabetes Mellitus, Type 1, run by GlaxoSmithKline at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With All Adverse Events (AE) and Serious Adverse Events (SAE) (time frame: Up to 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00575159, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.