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

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	18 - 70
Updated:	10/18/2018
Start Date:	September 15, 2014
End Date:	January 27, 2017

A Phase 1 Double-blind, Placebo-controlled, Randomized, Single- And Multiple-ascending Dose Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Pf-06293620 In Subjects With Type 2 Diabetes Mellitus

A first in human study to determine the safety, tolerability and pharmacokinetics of single
and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus

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

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