Clinical trial NCT00372957: Study Of GW823093 In Japanese Subjects With Type 2 Diabetes Mellitus
Official title: PK/PD Study of GW823093 in Japanese Subjects With T2DM: A Single-blind, Placebo Controlled, Randomized, Multi-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GW823093C Administered Orally for 7 Days in Japanese Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: pharmacodynamics
Diabetes
pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: 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)
measure: Percent Dipeptidyl-peptidase IV (DPP-IV) Inhibition by Dose (Day 7)
timeFrame: Day 7
measure: DPP-IV Activity Weighted Mean AUCs at Baseline (Day -1) and Day 7
timeFrame: Baseline (Day -1) and Day 7
measure: Active Glucagon-like Peptide-1 (GLP-1) Weighted Mean AUCs at Baseline (Day -1) and Day 7
timeFrame: Baseline (Day -1) and Day 7
measure: Insulin Weighted Mean AUCs at Baseline (Day -1) and Day 7
timeFrame: Baseline (Day -1) and Day 7
measure: Glucagon Weighted Mean AUCs at Baseline (Day -1) and Day 7
timeFrame: Baseline (Day -1) and Day 7
measure: C-peptide Weighted Mean AUCs at Baseline (Day -1) and Day 7
timeFrame: Baseline (Day -1) and Day 7
measure: Glucose Weighted Mean AUCs at Baseline (Day -1) and Day 7
timeFrame: Baseline (Day -1) and Day 7
Secondary outcomes:
measure: 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])
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: