Phase 1
Completed N=37
A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02038764 ↗
Enrolled (actual)
37
Serious AEs
2.7%
Results posted
Aug 2018
Primary outcomePrimary: Number of Participants With Dose Limiting or Intolerable Treatment Related Adverse Events (AEs) — 0; 0; 0; 0 participants
Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting or Intolerable Treatment Related Adverse Events (AEs) |
0; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With All-Causality Treatment Emergent Adverse Events(TEAEs) |
7; 8; 7; 5; 6 | — |
| PRIMARY Number of Participants With Treatment-Related TEAEs |
5; 6; 6; 4; 5 | — |
| PRIMARY Number of Participants With All-Causality TEAEs Listed by Common Terminology Criteria for Adverse Events (CTCAE) Grade |
3; 2; 1; 3; 1; 2 | — |
| PRIMARY Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events |
4; 4; 5; 1; 3 | — |
| PRIMARY Number of Participants With All-Causality Treatment-Emergent Hypoglycemic Adverse Events Listed by CTCAE Grade |
1; 0; 1; 0; 0; 1 | — |
| PRIMARY Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) |
7; 7; 8; 5; 7 | — |
| PRIMARY Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Absolute Values) |
0; 0; 1; 0; 0; 1 | — |
| PRIMARY Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Decreases From Baseline) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Vital Signs That Met the Criteria for Potential Clinical Concern(Increases From Baseline) |
0; 0; 0; 1; 0; 1 | — |
| PRIMARY Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Absolute Value) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Electrocardiogram(ECG) Data That Met the Criteria for Potential Clinical Concern(Increases From Baseline) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Serum Anti-PF-06342674 Antibody Response Listed by Visit |
2; 8; 9; 5; 8; 0 | — |
| SECONDARY Area Under Concentration-Time Curve From Time Zero to Time Tau(AUCtau) on Day 1 and Day 71 |
384900; 1323000; 2570000; 5805000; 426700; 2029000 | — |
| SECONDARY Apparent Oral Clearance (CL/F) on Day 71 |
2.340; 1.477; NA; 1.017 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) on Day 1 and Day 71 |
2114; 8512; 20890; 31610; 2612; 10600 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1 and Day 71 |
48.8; 48.9; 48.1; 51.8; 48.9; 60.2 | — |
| SECONDARY Plasma Decay Half-Life (t1/2) on Day 71 |
NA; 64.62; NA; 85.54 | — |
| SECONDARY Apparent Volume of Distribution (Vz/F) on Day 71 |
NA; 141.2; NA; 129.5 | — |
| SECONDARY Accumulation Ratio (Rac) on Day 71 |
1.115; 1.532; NA; 1.355 | — |
Eligibility Criteria
Inclusion Criteria
- Women and men age 18 and older.
- Diagnosis of type 1 diabetes within 2 years of randomization.
- Peak stimulated C-peptide levels ≥ 0.15 ng/mL.
Exclusion Criteria
- Anticipated ongoing use of diabetes medications other than insulin.
- Evidence or history of diabetic complications with significant end-organ damage.
- Episode of severe hypoglycemia within 60 days of randomization.
- Multiple hospitalizations for diabetic ketoacidosis.
Data sourced from ClinicalTrials.gov (NCT02038764). 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.