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Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272804
First Posted: January 10, 2011
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: December 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus, Type 2
NIDDM
Interventions: Drug: PF-04937319
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PF-04937319 10 mg Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
PF-04937319 30 mg Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
PF-04937319 50 mg Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
PF-04937319 100 mg Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
PF-04937319 300 mg Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
Placebo Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.

Participant Flow:   Overall Study
    PF-04937319 10 mg   PF-04937319 30 mg   PF-04937319 50 mg   PF-04937319 100 mg   PF-04937319 300 mg   Placebo
STARTED   9   9   9   9   9   16 
COMPLETED   8   9   9   9   7   15 
NOT COMPLETED   1   0   0   0   2   1 
Adverse Event                1                0                0                0                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set included all participants who received at least 1 dose of study medication.

Reporting Groups
  Description
PF-04937319 10 mg Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
PF-04937319 30 mg Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
PF-04937319 50 mg Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
PF-04937319 100 mg Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
PF-04937319 300 mg Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
Placebo Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
Total Total of all reporting groups

Baseline Measures
   PF-04937319 10 mg   PF-04937319 30 mg   PF-04937319 50 mg   PF-04937319 100 mg   PF-04937319 300 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   9   9   9   9   16   61 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.6  (9.2)   49.4  (7.8)   54.2  (5.4)   51.4  (10.6)   56.4  (5.8)   57.3  (5.8)   54.4  (7.7) 
Gender 
[Units: Participants]
Count of Participants
             
Female      4  44.4%      0   0.0%      2  22.2%      3  33.3%      3  33.3%      6  37.5%      18  29.5% 
Male      5  55.6%      9 100.0%      7  77.8%      6  66.7%      6  66.7%      10  62.5%      43  70.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days) ]

2.  Primary:   Maximum Observed Plasma Concentration (Cmax) On Day 1   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition) ]

3.  Primary:   Maximum Observed Plasma Concentration (Cmax) On Day 6   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition) ]

4.  Primary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition) ]

5.  Primary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition) ]

6.  Primary:   Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition) ]

7.  Primary:   Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) ]

8.  Primary:   Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) ]

9.  Primary:   Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) ]

10.  Primary:   Plasma Decay Half-Life (t1/2) on Day 14   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition) ]

11.  Primary:   Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition) ]

12.  Primary:   Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14   [ Time Frame: 0 hour (pre-dose) through 24 hours post-dose on Day 14 ]

13.  Primary:   Apparent Oral Clearance (CL/F) on Day 14   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) ]

14.  Primary:   Apparent Volume of Distribution (Vz/F) on Day 14   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition) ]

15.  Primary:   Observed Accumulation Ratio for AUCtau (Rac)   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition) ]

16.  Primary:   Observed Accumulation Ratio for Cmax (Rac, Cmax)   [ Time Frame: 0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition) ]

17.  Primary:   Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1   [ Time Frame: -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 (fasted condition) ]

18.  Primary:   Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14   [ Time Frame: -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 14 (fasted condition) ]

19.  Secondary:   Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14   [ Time Frame: -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition) ]

20.  Secondary:   Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14   [ Time Frame: -46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition) ]

21.  Secondary:   Change From Baseline in Average Plasma Glucose at Day 1, 6, 14   [ Time Frame: -46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14 ]

22.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15   [ Time Frame: Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 ]

23.  Secondary:   Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up   [ Time Frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication) ]

24.  Secondary:   Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up   [ Time Frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication) ]

25.  Secondary:   Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up   [ Time Frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication) ]

26.  Secondary:   Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up   [ Time Frame: Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication) ]

27.  Secondary:   Change From Baseline in Lactate Level at Day 6 and 14   [ Time Frame: Baseline (Day 1), Day 6 and 14 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01272804     History of Changes
Other Study ID Numbers: B1621003
First Submitted: January 6, 2011
First Posted: January 10, 2011
Results First Submitted: December 6, 2016
Results First Posted: February 1, 2017
Last Update Posted: February 1, 2017