Phase 2
Completed N=30
Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT00372957 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Standard Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Drug Concentration (Cmax) — 238.166; 419.937; 262.523; 534.888 Nanograms per milliliter (ng/mL)
Summary
To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standard Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Drug Concentration (Cmax) |
238.166; 419.937; 262.523; 534.888 | — |
| PRIMARY Standard PK Parameter: Time at Which Cmax Was Observed (Tmax) |
2.50; 3.50; 3.00; 2.00 | — |
| PRIMARY Standard PK Parameter: Half Life of Terminal Elimination Phase (t1/2) |
6.662; 8.788; 7.127; 9.648 | — |
| PRIMARY 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]) |
2261.076; 4800.677; 2545.651; 6129.987; 2508.608; 5786.001 | — |
| PRIMARY Standard PK Parameter: Percentage of AUC(0-inf) Obtained by Extrapolation (%AUCex) |
9.029; 16.645; 10.704; 18.442 | — |
| PRIMARY Standard PK Parameter: Constant Rate of Elimination (lambda_z) |
0.10403; 0.07887; 0.09727; 0.07184 | — |
| PRIMARY Standard PK Parameter: Total Clearance (CL/F) |
5.979; 5.185; 5.225; 3.967 | — |
| PRIMARY Standard PK Parameter: Apparent Volume of Distribution (Vz/F) |
57.470; 65.735; 53.724; 55.221 | — |
| PRIMARY Standard PK Parameter: R[Cmax], Extent of Accumulation (Ro), Steady State Accumulation Ratio (Rs) |
1.102; 1.274; 1.126; 1.277; 1.015; 1.059 | — |
| PRIMARY Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7) |
0.000; 69.565; 88.854; 2.273; 83.612; 88.854 | — |
| PRIMARY DPP-IV Activity Weighted Mean AUCs at Baseline (Day -1) and Day 7 |
2.34; 2.43; 2.41; 2.35; 0.27; 0.21 | — |
| PRIMARY Active Glucagon-like Peptide-1 (GLP-1) Weighted Mean AUCs at Baseline (Day -1) and Day 7 |
4.64; 3.21; 5.48; 4.74; 7.19; 10.79 | — |
| PRIMARY Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7 |
17.35; 17.55; 21.28; 18.07; 16.70; 22.79 | — |
| PRIMARY Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7 |
113.1; 100.1; 125.1; 113.9; 97.3; 105.6 | — |
| PRIMARY C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7 |
4.29; 3.78; 4.73; 4.46; 4.31; 5.25 | — |
| PRIMARY Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7 |
218.9; 233.8; 227.5; 210.0; 203.2; 208.6 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
1; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion 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.
Exclusion criteria
- Must not have any other major illness other than diabetes
Data sourced from ClinicalTrials.gov (NCT00372957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.