NCT01933672

Brief Summary

Study B1621019 will assess efficacy and safety of two different dosing regimens of an investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients with type 2 diabetes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

September 27, 2016

Completed
Last Updated

September 27, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 28, 2013

Results QC Date

June 17, 2016

Last Update Submit

August 3, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

Phase 1btype 2 diabetesmetformin backgroundPF-04937319

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Weighted Mean Daily Glucose (WMDG) at Day 14

    Plasma glucose concentration was determined predose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours postdose on Days 0 (baseline) and 14. WMDG was calculated as the area under the curve (AUC) of the 12-point plasma glucose concentration-time profile divided by 24 hours.

    Prior to morning dose (Hour 0) and at 1.5, 3, 5, 6.5, 8, 11, 12.5, 14, 16, 20, and 24 hours post morning dose on Days 0 (baseline) and Day 14

Secondary Outcomes (14)

  • Change From Baseline in Fasting Plasma Glucose (FPG) at Day 14

    Day 14

  • Change From Baseline in Pre-meal C-Peptide on Day 14

    Day 14

  • Change From Baseline in Pre-meal Insulin on Day 14

    Day 14

  • Incidence of All Causality Treatment-Emergent Adverse Event by Preferred Term (Frequency Rate >5%)

    Day 1 up to Day 14

  • Frequency of Laboratory Test Abnormalities Reported in Any Treatment Group

    Day 1 up to Day 14

  • +9 more secondary outcomes

Study Arms (3)

PF-04937319 once-daily

EXPERIMENTAL
Drug: PF-04937319 once-daily

PF-04937319 split-dose

EXPERIMENTAL
Drug: PF-04937319 split-dose

Sitagliptin once-daily

ACTIVE COMPARATOR
Drug: Sitagliptin once-daily

Interventions

PF-04937319 once-dailyDRUG

Tablets, 300 mg once-daily with breakfast, 14-days

PF-04937319 once-daily
PF-04937319 split-doseDRUG

tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days

PF-04937319 split-dose
Sitagliptin once-dailyDRUG

tablets, 100 mg once-daily with breakfast, 14-days

Sitagliptin once-daily

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with type 2 diabetes, on background metformin therapy either alone or with 1 other oral anti-diabetic agent (excluding Actos)

You may not qualify if:

  • Patients with cardiovascular event within 6-months of screening
  • Patients with diabetic complications
  • Female subjects who are pregnant or planning to become pregnant
  • Subjects with unstable medical conditions (eg, hypertension)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Miami Research Associates, Inc.

South Miami, Florida, 33143, United States

Location

MRA Clinical Research, LLC

South Miami, Florida, 33143, United States

Location

High Point Clinical Trials Center, LLC

High Point, North Carolina, 27265, United States

Location

Community Research

Cincinnati, Ohio, 45255, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

Spaulding Clinical Research, LLC

West Bend, Wisconsin, 53095, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 2, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

September 27, 2016

Results First Posted

September 27, 2016

Record last verified: 2016-08

Locations

US(8)