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

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ClinicalTrials.gov Identifier: NCT01475461
Recruitment Status : Completed
First Posted : November 21, 2011
Results First Posted : January 31, 2017
Last Update Posted : January 31, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Placebo
Drug: PF-04937319 - 3mg
Drug: PF-04937319 - 20mg
Drug: PF-04937319 - 50mg
Drug: PF-04937319 - 100mg
Drug: Sitagliptin - 100mg

  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
Total 615 participants were consented,of which 376 participants entered to run-in period to receive sponsor provided Metformin, 345 participants then randomized to study treatment,of these 335 were treated. Results were collected for 335 participants as data from 1 site (10 participants) were excluded due to major good clinical practice violations.

Reporting Groups
  Description
Metformin 500 mg Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
Placebo Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 3 mg PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 20 mg PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 50 mg PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 100 mg PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Sitagliptin 100 mg Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.

Participant Flow for 2 periods

 Period 1:   Run-in Period
    Metformin 500 mg   Placebo   PF-04937319 3 mg   PF-04937319 20 mg   PF-04937319 50 mg   PF-04937319 100 mg   Sitagliptin 100 mg
STARTED   376   0   0   0   0   0   0 
COMPLETED   335   0   0   0   0   0   0 
NOT COMPLETED   41   0   0   0   0   0   0 
Not meet eligibility criteria                16                0                0                0                0                0                0 
Lost to Follow-up                7                0                0                0                0                0                0 
Withdrawal by Subject                11                0                0                0                0                0                0 
Other                3                0                0                0                0                0                0 
Protocol Violation                4                0                0                0                0                0                0 

Period 2:   Treatment Period
    Metformin 500 mg   Placebo   PF-04937319 3 mg   PF-04937319 20 mg   PF-04937319 50 mg   PF-04937319 100 mg   Sitagliptin 100 mg
STARTED   0   57   57   54   56   56   55 
COMPLETED   0   48   53   46   52   51   53 
NOT COMPLETED   0   9   4   8   4   5   2 
Death                0                0                0                1                0                0                0 
Lost to Follow-up                0                3                2                3                1                2                1 
Withdrawal by Subject                0                2                2                0                2                2                0 
Other                0                1                0                0                0                0                0 
Protocol Violation                0                1                0                0                0                0                1 
Lack of Efficacy                0                2                0                2                1                1                0 
Medication Error                0                0                0                1                0                0                0 
Adverse Event                0                0                0                1                0                0                0 



  Baseline Characteristics

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.
Baseline analysis population included all randomized participants who received at least 1 dose of study treatment.

Reporting Groups
  Description
Placebo Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 3 mg PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 20 mg PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 50 mg PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 100 mg PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Sitagliptin 100 mg Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo   PF-04937319 3 mg   PF-04937319 20 mg   PF-04937319 50 mg   PF-04937319 100 mg   Sitagliptin 100 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 57   57   54   56   56   55   335 
Age, Customized 
[Units: Participants]
 		             
>=18 to =<44 years   15   17   14   15   15   17   93 
>=45 to =<64 years   42   40   40   41   41   38   242 
Gender 
[Units: Participants]
Count of Participants 		             
Female      21  36.8%      29  50.9%      22  40.7%      23  41.1%      26  46.4%      22  40.0%      143  42.7% 
Male      36  63.2%      28  49.1%      32  59.3%      33  58.9%      30  53.6%      33  60.0%      192  57.3% 


  Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12   [ Time Frame: Baseline (Day 1), Week 12 ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4 and 8   [ Time Frame: Baseline(Day 1), Week 2, 4, 8 ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 1, 2, 4, 8, 12 and 14   [ Time Frame: Baseline (Day 1), Week 1, 2, 4, 8, 12, 14 ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Increase From Baseline Electrocardiogram (ECG)Data   [ Time Frame: Baseline (Day 1) up to Week 14 ]
  Show Outcome Measure 5

6.  Secondary:   Number of Participants With Increase/Decrease From Baseline Vital Signs Data   [ Time Frame: Baseline (Day 1) up to Week 14 ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline (Day 1) up to 14 days after last dose (up to 101 days) ]
  Show Outcome Measure 7

8.  Secondary:   Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode   [ Time Frame: Baseline (Day 1) up to Week 14 ]
  Show Outcome Measure 8

9.  Secondary:   Number of Hypoglycemic Events (HAE) Episodes Per Participant   [ Time Frame: Baseline (Day 1) up to Week 14 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Body Weight at Week 2, 4, 8, 12 and 14   [ Time Frame: Baseline (Day 1), Week 2, 4, 8 , 12 , 14 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants With Abnormal Laboratory Values   [ Time Frame: Baseline (Day 1) up to Week 14 ]
  Show Outcome Measure 11


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01475461     History of Changes
Other Study ID Numbers: B1621007
2011-004002-25 ( EudraCT Number )
First Submitted: September 15, 2011
First Posted: November 21, 2011
Results First Submitted: December 6, 2016
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017