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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00638313
First received: March 12, 2008
Last updated: July 30, 2009
Last verified: March 2008
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Biological: Placebo
Biological: PF-04603629
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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. [ Time Frame: 1 week per dose group ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • No secondary outcomes listed in the protocol. [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: August 2007
Study Completion Date: February 2008
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00638313     History of Changes
Other Study ID Numbers: B0571001
Study First Received: March 12, 2008
Last Updated: July 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
GLP-1

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

ClinicalTrials.gov processed this record on July 28, 2014