A study to assess the safety of single doses of GSK189075 in subjects with type 1 diabetes mellitus
Trial overview
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.
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
Participation 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
- Pregnant or a nursing female.
- Have a past or current disease such as heart, liver, kidney, blood, brain, or other disease.
- 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.
- 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)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
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.