Study Of Safety And Efficacy Of PF-04991532 In Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01336738
First received: April 13, 2011
Last updated: June 5, 2013
Last verified: June 2013
Results First Received: June 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes, Type 2
Interventions: Drug: Placebo
Drug: 150 mg PF-04991532
Drug: 450 mg PF-04991532
Drug: 750 mg PF-04991532
Drug: Sitagliptin 100 mg

  Participant Flow
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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
All participants received placebo matched to PF-04991532 or placebo matched to sitagliptin tablet orally once daily along with background metformin immediate release tablets, during the 2-week run-in period. Compliant participants were then randomized to study treatments for 12 weeks.

Reporting Groups
  Description
PF-04991532 150 mg PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 450 mg PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 750 mg PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Sitagliptin 100 mg Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Placebo Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.

Participant Flow:   Overall Study
    PF-04991532 150 mg     PF-04991532 450 mg     PF-04991532 750 mg     Sitagliptin 100 mg     Placebo  
STARTED     52     54     53     54     53  
COMPLETED     45     45     45     47     43  
NOT COMPLETED     7     9     8     7     10  
Adverse Event                 0                 3                 2                 1                 3  
Lost to Follow-up                 2                 1                 2                 2                 2  
Did not meet entrance criteria                 0                 1                 0                 0                 0  
Protocol Violation                 0                 1                 0                 0                 0  
Withdrawal by Subject                 2                 0                 2                 1                 1  
Unspecified                 3                 3                 2                 3                 4  



  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.
No text entered.

Reporting Groups
  Description
PF-04991532 150 mg PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 450 mg PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
PF-04991532 750 mg PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Sitagliptin 100 mg Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Placebo Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
Total Total of all reporting groups

Baseline Measures
    PF-04991532 150 mg     PF-04991532 450 mg     PF-04991532 750 mg     Sitagliptin 100 mg     Placebo     Total  
Number of Participants  
[units: participants]
  52     54     53     54     53     266  
Age  
[units: years]
Mean ± Standard Deviation
  55.3  ± 9.9     55.1  ± 9.3     55.5  ± 7.3     57.8  ± 8.3     55.6  ± 8.5     55.9  ± 8.7  
Gender  
[units: Participants]
           
Female     16     24     17     23     14     94  
Male     36     30     36     31     39     172  



  Outcome Measures
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1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 12   [ Time Frame: Baseline, Week 12 ]

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

3.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 1, 2, 4 and 8   [ Time Frame: Baseline, Week 1, 2, 4, 8 ]

4.  Secondary:   Percentage of Participants Achieving Less Than (<) 6.5% or <7% Glycosylated Hemoglobin (HbA1c) Levels   [ Time Frame: Week 12 ]

5.  Secondary:   Change From Baseline in Body Weight at Week 1, 2, 4, 8 and 12   [ Time Frame: Baseline, Week 1, 2, 4, 8, 12 ]

6.  Secondary:   Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Gain From Baseline   [ Time Frame: Week 12 ]

7.  Secondary:   Percentage of Participants With Greater Than or Equal to (>=) 1% or >= 2% Body Weight Loss From Baseline   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
No text entered.  


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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01336738     History of Changes
Other Study ID Numbers: B2611002
Study First Received: April 13, 2011
Results First Received: June 5, 2013
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration