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Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects

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ClinicalTrials.gov Identifier: NCT00638313
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : July 31, 2009
Sponsor:
Information provided by:
Pfizer

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Biological: Placebo Biological: PF-04603629 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : August 2007
Actual Study Completion Date : February 2008

Arm Intervention/treatment
Placebo Comparator: Placebo Biological: Placebo
Subjects will be given either Placebo or PF-04603629.
Experimental: PF-04603629 Biological: PF-04603629
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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Measures :
  1. No secondary outcomes listed in the protocol.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638313


Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00638313     History of Changes
Other Study ID Numbers: B0571001
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: July 31, 2009
Last Verified: March 2008

Keywords provided by Pfizer:
GLP-1

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases