Status:
COMPLETED
A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Pfizer
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2017
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT02211261
Start Date
September 15 2014
End Date
January 27 2017
Last Update
October 16 2018
Active Locations (7)
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1
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States, 91911
2
Profil Institute for Clinical Research, Incorporated
Chula Vista, California, United States, 91911
3
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
4
Orlando Clinical Research Center
Orlando, Florida, United States, 32809