Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
Trial overview
Standard pharmacokinetic (PK) parameter: Maximum observed plasma drug concentration (Cmax)
Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hours [hr]), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)
Standard PK parameter: Time at which Cmax was observed (Tmax)
Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)
Standard PK parameter: Half life of terminal elimination phase (t1/2)
Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)
Standard PK parameter: Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC[0-inf]), AUC from 0 to the last measurable concentration (AUC[0-t])
Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)
Standard PK parameter: Percentage of AUC(0-inf) obtained by extrapolation (%AUCex)
Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)
Standard PK parameter: Constant rate of elimination (lambda_z)
Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)
Standard PK parameter: Total clearance (CL/F)
Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)
Standard PK parameter: Apparent volume of distribution (Vz/F)
Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)
Standard PK parameter: R[Cmax], Extent of accumulation (Ro), Steady state accumulation ratio (Rs)
Timeframe: Day 1 (at 0, 1, 1.5, 2, 3, 4, 6, 8, 12 hr), Day 2 (0 hr) and Day 7 (0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hr)
Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7)
Timeframe: Day 7
DPP-IV activity weighted mean AUCs at Baseline (Day -1) and Day 7
Timeframe: Baseline (Day -1) and Day 7
Active Glucagon-like peptide-1 (GLP-1) weighted mean AUCs at Baseline (Day -1) and Day 7
Timeframe: Baseline (Day -1) and Day 7
Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7
Timeframe: Baseline (Day -1) and Day 7
Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7
Timeframe: Baseline (Day -1) and Day 7
C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7
Timeframe: Baseline (Day -1) and Day 7
Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7
Timeframe: Baseline (Day -1) and Day 7
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to post-study screen (Follow-up [7 days after the last dose of study medication])
Participation criteria
- T2DM diagnosed at least 3 months prior to Screening and fasting plasma glucose (FPG) level <280mg/dL at the Screening visit.
- Concurrent T2DM therapy: Must be diet controlled - OR - not taking more than 2 oral anti-diabetic agents, and willing to withdraw from these treatments 2 weeks prior to the first dosing.
- Must not have any other major illness other than diabetes
- T2DM diagnosed at least 3 months prior to Screening and fasting plasma glucose (FPG) level <280mg/dL at the Screening visit.
- Concurrent T2DM therapy: Must be diet controlled
- OR
- not taking more than 2 oral anti-diabetic agents, and willing to withdraw from these treatments 2 weeks prior to the first dosing.
- Must not have any other major illness other than diabetes
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.