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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00886821
• Other study ID #: B1111001
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2009
• Last updated: July 30, 2015
• Start date: October 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Miami Gardens	Florida
United States	Pfizer Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of escalating, subcutaneous doses of CVX-096 administered to adult subjects with T2DM		Throughout duration of study	Yes
Secondary	To characterize the pharmacokinetics of CVX-096 in serum after administration, under fasting conditions, of escalating, subcutaneous doses of CVX-096 to adult subjects with T2DM		Throughout duration of study	Yes
Secondary	To characterize the pharmacodynamic effect (glucose AUC lowering) of escalating, subcutaneous doses of CVX-096 administered to adult subjects with T2DM		Throughout duration of study	No
Secondary	To evaluate the effect on mean plasma glucose (MPG) after receiving doses of CVX-096		Throughout duration of study	No
Secondary	To assess immunogenicity		Throughout duration of study	Yes

External Links

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