A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
NCT00886821
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Adult Trials: 18+ Years
- 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.
- 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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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics | |||
| Official Title ICMJE | 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 | |||
| Brief Summary | The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Diabetes Mellitus, Type 2 | |||
| Intervention ICMJE | Biological: CVX-096
Subcutaneous administration of CVX-096 with doses ranging from 0.1 mg up to a maximum of 36 mg | |||
| Study Arms ICMJE | Experimental: 1
Intervention: Biological: CVX-096 | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 114 | |||
| Original Estimated Enrollment ICMJE | 48 | |||
| Actual Study Completion Date ICMJE | June 2011 | |||
| Actual Primary Completion Date | June 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00886821 | |||
| Other Study ID Numbers ICMJE | B1111001 CVX-096-101 ( Other Identifier: Alias Study Number ) | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||