A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Completed · Phase 1 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
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
Key facts
- Study ID
- NCT02211261
- Run by
- Pfizer
- People needed
- 84
- Starts
- 2014-09-15
- Expected to finish
- 2017-01-27
- Last updated by the study team
- 2018-10-16
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Profil Institute for Clinical Research, Inc. — Chula Vista, California, United States
- Profil Institute for Clinical Research, Incorporated — Chula Vista, California, United States
- Avail Clinical Research, LLC — DeLand, Florida, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
- Qps Mra, Llc — South Miami, Florida, United States
- Qps-Mra Llc — South Miami, Florida, United States
- High Point Clinical Trials Center, LLC — High Point, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.