A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

CVX-096

Intervention Type BIOLOGICAL

Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg

Interventions

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CVX-096

Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No