Back to resultsSingle-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
PF-04603629
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring GLP-1
Eligibility Criteria
Inclusion Criteria:
- Type 2 diabetes mellitus
- Hb A1c lower or equal to 11%
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Evidence of diabetic complications with significant end-organ damage
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
PF-04603629
Arm Description
Outcomes
Primary Outcome Measures
To characterize the pharmacokinetics of PF-04603629 in serum after administration, under fasted conditions, of single, escalating, subcutaneous doses of PF-04603629 to adult subjects with T2DM.
To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
To evaluate the safety and tolerability of escalating, single subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
Secondary Outcome Measures
No secondary outcomes listed in the protocol.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00638313
Brief Title
Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects
Official Title
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Subcutaneous Doses Of PF-04603629 In Type 2 Diabetic Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
GLP-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
PF-04603629
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Subjects will be given either Placebo or PF-04603629.
Intervention Type
Biological
Intervention Name(s)
PF-04603629
Intervention Description
Subjects will be given either Placebo or PF-04603629. The specific dose of PF-04603629 given depended on the Cohort to which the patient was assigned. Doses administered ranged from 1 mg to 70 mg.
Primary Outcome Measure Information:
Title
To characterize the pharmacokinetics of PF-04603629 in serum after administration, under fasted conditions, of single, escalating, subcutaneous doses of PF-04603629 to adult subjects with T2DM.
Time Frame
1 week per dose group
Title
To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
Time Frame
1 week per dose group
Title
To evaluate the safety and tolerability of escalating, single subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
Time Frame
1 week per dose group
Secondary Outcome Measure Information:
Title
No secondary outcomes listed in the protocol.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes mellitus
Hb A1c lower or equal to 11%
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Evidence of diabetic complications with significant end-organ damage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0571001&StudyName=Single-Dose%20Study%20Of%20PF-04603629%20In%20Type%202%20Diabetic%20Subjects
Description
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Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects
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