Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01475461

First received: September 15, 2011

Last updated: February 20, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 15, 2011

Last Updated Date

February 20, 2013

Start Date ^ICMJE

November 2011

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HbA1C - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01475461 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Fasting plasma glucose - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
Vitals - systolic blood pressure (SBP), diastolic blood pressue (DBP), heart rate [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
12-lead electrocardiograms (ECGs) [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
Body weight [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
Clinical laboratory tests - hematology, chemistry, lipid profile, urinalysis [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Fasting plasma glucose - change from baseline [ Time Frame: 84-days ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
Vitals - systolic blood pressure (SBP), diastolic blood pressue (DBP), heart rate [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
12-lead electrocardiograms (ECGs) [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
Body weight [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]
Clinical laboratory tests - hematology, chemistry, lipid profile, urinalysis [ Time Frame: 84-days ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Phase 2 Study To Evaluate Safety And Efficacy Of Investigational Drug - PF04937319 In Patients With Type 2 Diabetes

Official Title ^ICMJE

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate Safety And Efficacy Of PF-04937319 And Sitagliptin On Glycemic Control In Adult Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Metformin

Brief Summary

B1621007 is designed to study the safety and efficacy of PF-04937319 in patients with type 2 diabetes

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Drug: Placebo
double-dummy placebo tablets administered once-daily for 84-days
Drug: PF-04937319 - 3mg
PF-04937319 3mg administered as tablets once-daily for 84-days
Drug: PF-04937319 - 20mg
PF-04937319 20mg administered as tablets once-daily for 84-days
Drug: PF-04937319 - 50mg
PF-04937319 50mg administered as tablets once-daily for 84-days
Drug: PF-04937319 - 100mg
PF-04937319 100mg administered as tablets once-daily for 84-days
Drug: Sitagliptin - 100mg
Sitagliptin 100mg administered as tablets once-daily for 84-days

Study Arm (s)

Placebo Comparator: Placebo
Intervention: Drug: Placebo
Experimental: PF-04937319 - Dose 1
Intervention: Drug: PF-04937319 - 3mg
Experimental: PF-04937319 - Dose 2
Intervention: Drug: PF-04937319 - 20mg
Experimental: PF-04937319 - Dose 3
Intervention: Drug: PF-04937319 - 50mg
Experimental: PF-04937319 - Dose 4
Intervention: Drug: PF-04937319 - 100mg
Active Comparator: Sitagliptin
Intervention: Drug: Sitagliptin - 100mg

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

345

Completion Date

January 2013

Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients with type 2 diabetes, on metformin, age between 18-55 yrs, male or female

Exclusion Criteria:

patients with type 1 diabetes, medically unstable, unacceptable clinical laboratory test results at screening

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Hungary, India, Philippines, Romania, Slovakia, South Africa, Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01475461

Other Study ID Numbers ^ICMJE

B1621007

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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