Single-Dose And Multiple-Dose Safety And Tolerability Study Of PF-04856883 In Type 2 Diabetic Adult Females
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/11/2018 |
| Start Date: | March 2011 |
| End Date: | April 2012 |
A Phase 1, Double-blind, Placebo-controlled, Randomized, Parallel Group Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Pf-04856883 In Adult Female Subjects With Type 2 Diabetes Mellitus
The primary objective of this study is to evaluate the safety and tolerability of PF-04856883
(CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
(CVX-096) in adult female subjects with Type 2 diabetes mellitus on high dose of metformin.
Inclusion Criteria:
- History of Type 2 diabetes and currently being treated with high dose metformin
- BMI between 22.0 and 40.0 kg/m2
- HbA1c between 7.0-10.0%
- Fasting C-peptide >1.21 ng/mL
Exclusion Criteria:
- History of clinically significant chronic conditions other than Type 2 diabetes not
well controlled by either diet or medications
- Treatment with anti-diabetic therapies other than metformin
- History of allergic or anaphylactic reaction to any therapeutic or diagnostic
monoclonal antibody
- Males or women of childbearing potential
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