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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00638313

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 I

MedlinePlus related topics: Diabetes

Drug Information available for: Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Safety Study
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

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: Placebo Comparator	Biological: Placebo Subjects will be given either Placebo or PF-04603629.
PF-04603629: Experimental	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

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

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0571001
Study First Received:	March 12, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00638313
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

GLP-1

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on January 16, 2009