A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus

About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring first in human, single dose, multiple dose, escalation, safety study, Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
- Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
- HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
- Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at screening
Exclusion Criteria:
- History of Type 1 diabetes mellitus
- Evidence of diabetic complications with significant end-organ damage
- History of chronic pancreatitis or at high risk for pancreatitis
- Poorly controlled hypertension
- History of cardiovascular or cerebrovascular event or procedure
Sites / Locations
- Profil Institute for Clinical Research, Inc.
- Profil Institute for Clinical Research, Incorporated
- Avail Clinical Research, LLC
- Orlando Clinical Research Center
- Qps Mra, Llc
- Qps-Mra Llc
- High Point Clinical Trials Center, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Cohort 1-PF-06293620 or placebo
Cohort 2-PF-06293620 or placebo
Cohort 3-PF-06293620 or placebo
Cohort 4-PF-06293620 or placebo
Cohort 5-PF-06293620 or placebo
Cohort 6-PF-06293620 or placebo
Cohort 7 PF-06293620 or placebo
Cohort 8-PF-06293620 or placebo
Cohort 9-PF-06293620 or placebo
Single Ascending Dose PF-06293620 or placebo
Single Ascending Dose PF-06293620 or placebo
Single Ascending Dose PF-06293620 or placebo
Single Ascending Dose PF-06293620 or placebo
Single Ascending Dose PF-06293620 or placebo
Multiple Ascending Dose PF-06293620 or placebo
Multiple Ascending Dose PF-06293620 or placebo
Multiple Ascending Dose PF-06293620 or placebo
Multiple Ascending Dose PF-06293620 or placebo