Phase 1
Completed N=74
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
Source: ClinicalTrials.gov NCT00886821 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1 — 865; 4960; 7065; 32552 nanogram*hour per milliliter (ng*hr)/mL
Summary
The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1 |
865; 4960; 7065; 32552; 105950; 304167 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1 |
156; 72.1; 168; 72.0; 144; 120 | — |
| PRIMARY Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8 |
72.0 | — |
| PRIMARY Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22 |
48.0; 46.9; 48.0 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1 |
7.05; 29.0; 24.8; 149; 387; 900 | — |
| PRIMARY Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8 |
1536 | — |
| PRIMARY Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22 |
1767; 2193; 2253 | — |
| SECONDARY Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1 |
NA; 188; 151; 186; 144; 163 | — |
| SECONDARY Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8 |
156 | — |
| SECONDARY Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22 |
156; 102; 149 | — |
| SECONDARY Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1 |
NA; 310; 316; 350; 281; 319 | — |
| SECONDARY Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1 |
NA; 0.0176; 0.0643; 0.0562; 0.0487; 0.0354 | — |
| SECONDARY Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1 |
NA; 17013; 15550; 53420; 123081; 339062 | — |
Eligibility Criteria
Inclusion Criteria
- Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
- Hb A1c between 7-10%.
- Fasting C-peptide >0.4 nmol/L.
Exclusion Criteria
- History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
- Patients with pancreatitis or considered a high risk for pancreatitis.
- History of contraindications to metformin therapy.
- Previous treatment with an approved or investigational GLP 1 mimetic.
Data sourced from ClinicalTrials.gov (NCT00886821). 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.