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A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT02211261

Last Updated: 2018-10-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-15

Study Completion Date

2017-01-27

Brief Summary

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A first in human study to determine the safety, tolerability and pharmacokinetics of single and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1-PF-06293620 or placebo

Single Ascending Dose PF-06293620 or placebo

Group Type EXPERIMENTAL

PF-06293620

Intervention Type BIOLOGICAL

subcutaneous, single dose 0.3 mg/kg

Placebo

Intervention Type BIOLOGICAL

Subcutaneous normal saline single dose

Cohort 2-PF-06293620 or placebo

Single Ascending Dose PF-06293620 or placebo

Group Type EXPERIMENTAL

PF-06293620

Intervention Type BIOLOGICAL

Subcutaneous, single dose 1.0 mg/kg

Placebo

Intervention Type BIOLOGICAL

Subcutaneous normal saline single dose

Cohort 3-PF-06293620 or placebo

Single Ascending Dose PF-06293620 or placebo

Group Type EXPERIMENTAL

PF-06293620

Intervention Type BIOLOGICAL

Subcutaneous single dose 3 mg/kg

Placebo

Intervention Type BIOLOGICAL

Subcutaneous normal saline single dose

Cohort 4-PF-06293620 or placebo

Single Ascending Dose PF-06293620 or placebo

Group Type EXPERIMENTAL

PF-06293620

Intervention Type BIOLOGICAL

Subcutaneous single dose 6 mg/kg

Placebo

Intervention Type BIOLOGICAL

Subcutaneous normal saline single dose

Cohort 5-PF-06293620 or placebo

Single Ascending Dose PF-06293620 or placebo

Group Type EXPERIMENTAL

PF-06293620

Intervention Type BIOLOGICAL

Intravenous infusion single dose 1 mg/kg

Placebo

Intervention Type BIOLOGICAL

Intravenous infusion normal saline single dose

Cohort 6-PF-06293620 or placebo

Multiple Ascending Dose PF-06293620 or placebo

Group Type EXPERIMENTAL

PF-06293620

Intervention Type BIOLOGICAL

Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)

Placebo

Intervention Type BIOLOGICAL

Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

Cohort 7 PF-06293620 or placebo

Multiple Ascending Dose PF-06293620 or placebo

Group Type EXPERIMENTAL

PF-06293620

Intervention Type BIOLOGICAL

Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)

Placebo

Intervention Type BIOLOGICAL

Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

Cohort 8-PF-06293620 or placebo

Multiple Ascending Dose PF-06293620 or placebo

Group Type EXPERIMENTAL

PF-06293620

Intervention Type BIOLOGICAL

Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)

Placebo

Intervention Type BIOLOGICAL

Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

Cohort 9-PF-06293620 or placebo

Multiple Ascending Dose PF-06293620 or placebo

Group Type EXPERIMENTAL

PF-06293620

Intervention Type BIOLOGICAL

Subcutaneous injection multiple dose TBD mg (Days TBD)

Placebo

Intervention Type BIOLOGICAL

Subcutaneous injection normal saline multiple dose (Days TBD)

Interventions

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PF-06293620

subcutaneous, single dose 0.3 mg/kg

Intervention Type BIOLOGICAL

Placebo

Subcutaneous normal saline single dose

Intervention Type BIOLOGICAL

PF-06293620

Subcutaneous, single dose 1.0 mg/kg

Intervention Type BIOLOGICAL

Placebo

Subcutaneous normal saline single dose

Intervention Type BIOLOGICAL

PF-06293620

Subcutaneous single dose 3 mg/kg

Intervention Type BIOLOGICAL

Placebo

Subcutaneous normal saline single dose

Intervention Type BIOLOGICAL

PF-06293620

Subcutaneous single dose 6 mg/kg

Intervention Type BIOLOGICAL

Placebo

Subcutaneous normal saline single dose

Intervention Type BIOLOGICAL

PF-06293620

Intravenous infusion single dose 1 mg/kg

Intervention Type BIOLOGICAL

Placebo

Intravenous infusion normal saline single dose

Intervention Type BIOLOGICAL

PF-06293620

Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)

Intervention Type BIOLOGICAL

Placebo

Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

Intervention Type BIOLOGICAL

PF-06293620

Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)

Intervention Type BIOLOGICAL

Placebo

Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

Intervention Type BIOLOGICAL

PF-06293620

Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)

Intervention Type BIOLOGICAL

Placebo

Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)

Intervention Type BIOLOGICAL

PF-06293620

Subcutaneous injection multiple dose TBD mg (Days TBD)

Intervention Type BIOLOGICAL

Placebo

Subcutaneous injection normal saline multiple dose (Days TBD)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Men and women of non-childbearing potential with Type 2 Diabetes Mellitus
* Subjects on stable doses of metformin \>/= 1500 mg daily (SAD cohorts) or \>/= 1000 mg daily (MAD cohorts) x 30 days prior to screening
* HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening
* Fasting C-peptide \>1.12 ng/mL (SAD cohorts) or \>/= 0.8 mg/mL (MAD cohorts) at screening

Exclusion Criteria

* History of Type 1 diabetes mellitus
* Evidence of diabetic complications with significant end-organ damage
* History of chronic pancreatitis or at high risk for pancreatitis
* Poorly controlled hypertension
* History of cardiovascular or cerebrovascular event or procedure
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Profil Institute for Clinical Research, Inc.

Chula Vista, California, United States

Site Status

Profil Institute for Clinical Research, Incorporated

Chula Vista, California, United States

Site Status

Avail Clinical Research, LLC

DeLand, Florida, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Qps Mra, Llc

South Miami, Florida, United States

Site Status

Qps-Mra Llc

South Miami, Florida, United States

Site Status

High Point Clinical Trials Center, LLC

High Point, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3501001&StudyName=A%20Phase%201%20Single%20Dose%20Study%20Of%20PF-06293620%20To%20Assess%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20In%20Subjects%20With%20Type%202%20Diabetes%20Mell

To obtain contact information for a study center near you, click here.

Other Identifiers

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B3501001

Identifier Type: -

Identifier Source: org_study_id

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