Phase 1
Completed N=12
A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy
Source: ClinicalTrials.gov NCT02292433 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 1; 6; 1; 0 participants
Summary
Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As Monotherapy
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) |
1; 6; 1; 0; 0; 0 | — |
| PRIMARY Number of Participants With Protocol Defined Hypoglycaemic Adverse Events (HAEs) |
1; 4; 0 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-04937319 |
345.8; 614.6 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-04937319 |
6.50; 6.50 | — |
| PRIMARY Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF-04937319 |
3308; 6379 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF-04937319 |
361.3; 692.0 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-04937319 |
6.50; 6.50 | — |
| PRIMARY Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF-04937319 |
3840; 7937 | — |
| PRIMARY Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF-04937319 |
44.82; 106.3 | — |
| PRIMARY Average Plasma Concentration (Cav) on Day 7 for PF-04937319 |
159.9; 330.6 | — |
| PRIMARY Apparent Oral Clearance on Day 7 for PF-04937319 |
434.0; 525.0 | — |
| PRIMARY Terminal Half-Life (t1/2) on Day 7 for PF-04937319 |
8.006; 10.01 | — |
| PRIMARY Apparent Volume of Distribution on Day 7 for PF-04937319 |
280.5; 414.6 | — |
| PRIMARY Accumulation Ratio (Rac) on Day 7 for PF-04937319 |
1.159; 1.244 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) on Day 1 for PF-06455349 |
310.5; 583.7 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 for PF-06455349 |
11.0; 11.0 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 1 for PF--06455349 |
5326; 10180 | — |
| SECONDARY Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 1 |
1.664; 1.649 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) on Day 7 for PF--06455349 |
464.0; 978.6 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 7 for PF-06455349 |
11.0; 11.0 | — |
| SECONDARY Area Under the Concentration-Time Curve (AUC24) From Time Zero to 24 Hour on Day 7 for PF--06455349 |
9346; 19380 | — |
| SECONDARY Pre-dose Plasma Concentration (Ctrough) on Day 7 for PF--06455349 |
321.8; 649.9 | — |
| SECONDARY Average Plasma Concentration (Cav) on Day 7 for PF--06455349 |
389.5; 807.0 | — |
| SECONDARY Terminal Half-Life (t1/2) on Day 7 for PF-06455349 |
15.80; NA | — |
| SECONDARY Accumulation Ratio (Rac) on Day 7 for PF-06455349 |
1.756; 1.903 | — |
| SECONDARY Metabolite to Parent Ratio for AUC24 (MRAUC24) on Day 7 |
2.516; 2.523 | — |
| SECONDARY Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 7 |
201.31; 184.38; 190.42; -23.58; -28.61; 4.88 | 0.0032 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Last Day of Treatment |
164.42; 156.96; 159.25; -31.08; -39.33; -13.92 | 0.0006 sig |
| SECONDARY Change From Baseline in Pre-Meal Insulin at Day 7 |
8.577; 9.038; 8.378; -0.828; -1.439; 0.594 | 0.0447 sig |
| SECONDARY Change From Baseline in Pre-Meal C-Peptide at Day 7 |
1.68; 1.90; 1.73; -0.38; -0.38; -0.14 | 0.0067 sig |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes, on diet/exercise therapy only or background therapy with 1 oral anti-diabetic agent (excluding Actos)
Exclusion Criteria
- Patients with cardiovascular event
- Patients with diabetic complications
- Female subjects who are pregnant or planning to become pregnant
- Subjects with unstable medical conditions (eg, hypertension)
Data sourced from ClinicalTrials.gov (NCT02292433). 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.