GSK189075, GW869682 Or Placebo In Type 2 Diabetic Patients
Trial overview
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to follow-up (Day 13)
Number of participants with vital sign data outside potential clinical concerns (PCC) for Systolic blood pressure (SBP), Diastolic blood pressure (DBP) and heart rate
Timeframe: Up to Day 13
Number of participants with electrocardiogram (ECG) parameters outside PCC
Timeframe: Up to Day 13
Number of participants with clinical laboratory data outside the normal reference range- serum electrolytes
Timeframe: Up to morning of Day 13 (follow- up)
clinical laboratory data- mean fluid balance
Timeframe: 0-24 hour time interval on Day -2, Day -1, Day 1, Day 11 and Day 12
Clinical laboratory data- mean creatinine clearance
Timeframe: 0-24 hour time interval on Day -2, Day -1, Day 1, Day 11 and Day 12
AUC(0-t), AUC(0-inf), AUC(0-tou) and AUC(0-24) of GSK189075 and its metabolites (GSK189074, GSK279782, and GSK333081) and GW869682 and its metabolite (GW869683)
Timeframe: Pre-dose (0.0 hour), post -dose 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0 and 12.0 hour at Day 1 and 11
Maximum observed plasma concentration (Cmax) on Day 1 and Day 11
Timeframe: Pre-dose (0.0 hour), post -dose 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0 and 12.0 hour at Day 1 and 11
Time to maximum observed plasma concentration (tmax) on Day 1 and Day 11
Timeframe: Pre-dose (0.0 hour), post -dose 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0 and 12.0 hour at Day 1 and 11
Terminal half life (t1/2) on Day 1 and Day 11
Timeframe: Pre-dose (0.0 hour), post -dose 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0 and 12.0 hour at Day 1 and 11
Apparent total body clearance (CL/F) for GSK189074 and GSK189075 on Day 1 and Day 11
Timeframe: Pre-dose (0.0 hour), post -dose 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0 and 12.0 hour at Day 1 and 11
AUC ratios for GSK189074, GSK279782, GSK333081, GW869683 on Day 11 using AUC(0-τ)
Timeframe: Pre-dose (0.0 hour), post -dose 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 2.5, 3.0, 4.0, 6.0, 8.0 and 12.0 hour at Day 11
GSK189074, GSK279782 and GSK333081: The amount of metabolites excreted during each urine collection interval on Day 1 and Day 11
Timeframe: Day 1 and Day 11
GSK189074, GSK279782 and GSK333081: the cumulative amount excreted over a dosing interval, Ae(0-τ)
Timeframe: Day 1 and 11
The percent of GSK189075 dose recovered in urine as each metabolite, and as all three metabolites
Timeframe: Day 1 and 11
Renal clearance (CLr) ratio for each of the three metabolites of GSK189075
Timeframe: Day 1 and 11
Plasma glucose concentration profiling: Change from Baseline in fasting plasma glucose
Timeframe: Baseline (Day -3) and Day 11 and 12
Plasma glucose concentration profiling: Change from Baseline in post-oral glucose tolerance test (OGTT) glucose [AUC glucose (0-6)]
Timeframe: Baseline (Day -3) and Day 12
Plasma glucose concentration profiling: Change from Baseline in post-OGTT glucose [AUC glucose (0-6) weighted mean]
Timeframe: Baseline (Day -3) and Day 12
Plasma glucose concentration profiling: Change from Baseline in total daily glucose [AUC glucose (0-24h)]
Timeframe: Baseline (Day -2) and Day 1 and 11
Plasma glucose concentration profiling: Change from baseline in total daily glucose [AUC glucose (0-24h) weighted mean]
Timeframe: Baseline (Day -2) and Day 1 and 11
Plasma insulin concentration profiling: Change from Baseline in fasting plasma insulin
Timeframe: Baseline (Day -3) and Day 11 and 12
Plasma insulin concentration profiling: Change from Baseline in post-OGTT insulin [AUC insulin (0-6h)]
Timeframe: Baseline (Day -1) and Day 12
Plasma insulin concentration profiling: Change from Baseline in post-OGTT insulin [AUC insulin (0-6h) weighted mean]
Timeframe: Baseline (Day -1) and Day 12
Plasma insulin concentration profiling: Change from Baseline in total daily insulin [AUC insulin (0-24)]
Timeframe: Baseline (Day -2) and Day 1 and 11
Plasma insulin concentration profiling: Change from Baseline in total daily insulin [AUC insulin (0-24h) weighted mean]
Timeframe: Baseline (Day -2) and Day 1 and 11
Plasma C-peptide concentration profiling: Change from Baseline in fasting plasma C-peptide
Timeframe: Baseline (Day -3) and Day 11 and 12
Plasma C-peptide concentration profiling: Change from Baseline in post-OGTT C-peptide [AUC C-peptide (0-6h)]
Timeframe: Baseline (Day -1) and Day 12
Plasma C-peptide concentration profiling: Change from Baseline in post-OGTT C-peptide [AUC C-peptide (0-6h) weighted mean]
Timeframe: Baseline (Day -1) and Day 12
Plasma C-peptide concentration profiling: total daily C-peptide [AUC C-peptide (0-24h)]
Timeframe: Baseline (Day -2) and Day 1 and 11
Plasma C-peptide concentration profiling: total daily C-peptide [AUC C-peptide (0-24h) weighted mean]
Timeframe: Baseline (Day -2) and Day 1 and 11
Urine volume and urinary glucose concentration for calculation of urine glucose excretion
Timeframe: Day -2, -1, 1, 11 and 12
Percent (%) excretion of the filtered glucose load
Timeframe: Day -2, -1, 1, 11 and 12
Change from Baseline in Weight
Timeframe: Baseline (Day -3) and Day 13
Change from Baseline in body mass index (BMI)
Timeframe: Baseline (Day -3) and Day 13
Change from Baseline in waist and hip circumference
Timeframe: Baseline (Day -3) and Day 13
Change from Baseline in waist to hip ratio
Timeframe: Baseline (Day -3) and Day 13
Participation criteria
- Inclusion criteria:
- Type 2 diabetes.
- Inclusion criteria:
- Type 2 diabetes.
- HbA1c (a measure of the average amount of sugar in blood over the last 2 or 3 months) levels are between 7.0 and 9.0.
- Taking 850mg or more per day metformin, but not taking any other diabetes medications.
- Must be medically able and willing to discontinue diabetic medications from at least 2 weeks prior to first study dose until the last study assessment.
- Diabetic subjects who have not yet started taking diabetes medications or whose diabetes is controlled by diet alone may also be eligible to enroll if their HbA1c is within 7.5 to 9.0.
- Women may be eligible if they are post-menopausal or surgically sterile.
- If taking ACE inhibitors, beta-blockers, calcium channel blockers, or statin type drugs, you may be eligible if your dose has been stable for at least 30 days prior to the start of the clinical trial. Exclusion criteria:
- Using illicit drugs, or have antibodies to hepatitis B, hepatitis C, or HIV.
- Have any major health problems other than type 2 diabetes.
- Require insulin therapy or oral antidiabetic medication other than metformin.
- Subjects who have had a urinary tract infection within 4 weeks of the start of the study or who have kidney disease.
- Subjects with either low or high blood pressure.
- Men who are unwilling to abstain from intercourse, or use a condom with a pregnant or nursing female, or who are unwilling to use a condom with another form of contraception with a female who could become pregnant.
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.