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Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01517373
First received: January 20, 2012
Last updated: December 6, 2016
Last verified: December 2016
Results First Received: December 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: Placebo
Drug: PF-04937319 10 mg
Drug: PF-04937319 50 mg
Drug: PF-04937319 100 mg
Drug: Glimepiride

  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
A total of 628 participants were consented. Of these, 361 participants transitioned to the run-in period and received sponsor provided background therapy of Metformin. Participants completed the run-in period were then randomized to receive either placebo, PF-04937319 (10, 50 or 100 milligram [mg]) or Glimepiride in treatment period.

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 and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 10 mg PF-04937319 10 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.
Glimepiride Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day 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 10 mg   PF-04937319 50 mg   PF-04937319 100 mg   Glimepiride
STARTED   361   0   0   0   0   0 
COMPLETED   304   0   0   0   0   0 
NOT COMPLETED   57   0   0   0   0   0 
Death                1                0                0                0                0                0 
Adverse Event                5                0                0                0                0                0 
Did not meet eligibility criteria                34                0                0                0                0                0 
Lost to Follow-up                1                0                0                0                0                0 
Withdrawal by Subject                12                0                0                0                0                0 
Sponsor Decision                3                0                0                0                0                0 
Unspecified                1                0                0                0                0                0 

Period 2:   Treatment Period
    Metformin 500 mg   Placebo   PF-04937319 10 mg   PF-04937319 50 mg   PF-04937319 100 mg   Glimepiride
STARTED   0   61   60   61   61   61 
COMPLETED   0   57   54   54   55   54 
NOT COMPLETED   0   4   6   7   6   7 
Adverse Event                0                0                0                0                0                2 
Lost to Follow-up                0                0                1                1                0                0 
Withdrawal by Subject                0                3                2                2                2                3 
Unspecified                0                0                0                0                1                0 
Protocol Violation                0                0                0                0                1                0 
Lack of Efficacy                0                1                1                3                2                0 
Medication error without AEs                0                0                2                1                0                2 



  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.
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 and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
PF-04937319 10 mg PF-04937319 10 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.
Glimepiride Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day 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 10 mg   PF-04937319 50 mg   PF-04937319 100 mg   Glimepiride   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   60   61   61   61   304 
Age, Customized 
[Units: Participants]
           
>=18 to =<44 years   8   4   8   11   7   38 
>=45 to =<64 years   45   48   40   35   48   216 
>64 years   8   8   13   15   6   50 
Gender 
[Units: Participants]
Count of Participants
           
Female      27  44.3%      26  43.3%      24  39.3%      32  52.5%      22  36.1%      131  43.1% 
Male      34  55.7%      34  56.7%      37  60.7%      29  47.5%      39  63.9%      173  56.9% 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8   [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 8 ]

3.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12   [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 8, 12 ]

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 ]

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

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

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 of study treatment (up to 101 days) ]

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

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

10.  Secondary:   Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant   [ Time Frame: Baseline (Day 1) up to Week 14 ]

11.  Secondary:   Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14   [ Time Frame: Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up) ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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


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

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01517373     History of Changes
Other Study ID Numbers: B1621002
2011-005206-30 ( EudraCT Number )
Study First Received: January 20, 2012
Results First Received: December 6, 2016
Last Updated: December 6, 2016