Phase 1
Completed N=98
4-Week, Multiple-dose, Dose-escalating Study In Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT03538743 ↗Enrolled (actual)
98
Serious AEs
1.0%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) — 17; 6; 8; 10 Participants
Summary
This is a dose-escalating study in patients with Type 2 diabetes on metformin. Participants will receive an investigational product or placebo for 28 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All-causality and Treatment-related Treatment-emergent Adverse Events (TEAEs) |
17; 6; 8; 10; 8; 8 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality |
24; 7; 8; 10; 8; 8 | — |
| PRIMARY Number of Participants With Abnormal Vital Signs |
3; 3; 2; 1; 3; 0 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiogram (ECG) Interval |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY AUC24 and AUCtau of PF-06882961 on Day 1, Day 14 or 21 and Day 28 |
707.5; 1502; 645.8; 666.1; 178.7; 324.0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 |
50.58; 124.4; 49.75; 51.61; 15.02; 26.02 | — |
| SECONDARY Time for Cmax (Tmax) of PF-06882961 on Day 1, Day 14 or 21 and Day 28 |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Terminal Half-life (t½) of PF-06882961 on Day 28 |
5.100; 5.067; 4.681; 6.203; 8.090; 6.730 | — |
| SECONDARY Amount of Unchanged Drug Recovered in Urine Over 24 Hours (Ae24) of PF-06882961 on Day 28 |
17.25; 33.60; 41.16; NA; 14.97; 62.63 | — |
| SECONDARY Ae24 (%) of PF-06882961 on Day 28 |
0.05747; 0.03360; 0.02942; NA; 0.07483; 0.02607 | — |
| SECONDARY Renal Clearance (CLr) of PF-06882961 on Day 28 |
0.3273; 0.3385; 0.3094; NA; 0.5470; 0.2006 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes treated with a stable dose of metformin at least 500 mg
- HbA1c value between 7.0 and 10.5%
Exclusion Criteria
- Type 1 diabetes or secondary forms of diabetes
Data sourced from ClinicalTrials.gov (NCT03538743). 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.