A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
| Status: | Completed |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | October 2008 |
| End Date: | June 2011 |
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Escalating Subcutaneous Doses Of CVX-096 In Type 2 Diabetic Adult Subjects
The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type
2 diabetic patients.
2 diabetic patients.
Inclusion Criteria:
- Male and/or female patients (females will be women of non-childbearing potential)
with an historical diagnosis of type 2 diabetes mellitus, who are currently being
treated with metformin at a dose at or near maximum.
- Hb A1c between 7-10%.
- Fasting C-peptide >0.4 nmol/L.
Exclusion Criteria:
- History of clinically significant chronic conditions other than T2DM not well
controlled by either diet or medications.
- Patients with pancreatitis or considered a high risk for pancreatitis.
- History of contraindications to metformin therapy.
- Previous treatment with an approved or investigational GLP 1 mimetic.
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