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A 6-Week Study Of PF-05175157 In Type 2 Diabetes Mellitus

This study has been terminated.
(The study was terminated prematurely on 16 May 2014 due to a safety concern.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01792635
First received: December 20, 2012
Last updated: December 22, 2016
Last verified: December 2016
Results First Received: January 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: PF-05175157
Drug: Placebo

  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
No text entered.

Reporting Groups
  Description
All Participants in Part A Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
Placebo - Part B Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
PF-05175157 200 mg Twice a Day - Part B Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.

Participant Flow for 2 periods

Period 1:   Part A
    All Participants in Part A   Placebo - Part B   PF-05175157 200 mg Twice a Day - Part B
STARTED   6   0   0 
COMPLETED   6   0   0 
NOT COMPLETED   0   0   0 

Period 2:   Part B
    All Participants in Part A   Placebo - Part B   PF-05175157 200 mg Twice a Day - Part B
STARTED   0   6   7 
COMPLETED   0   2   3 
NOT COMPLETED   0   4   4 
Adverse Event                0                0                1 
Study terminated                0                4                3 



  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
All Participants in Part A Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
Placebo - Part B Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
PF-05175157 200 mg Twice a Day - Part B Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
Total Total of all reporting groups

Baseline Measures
   All Participants in Part A   Placebo - Part B   PF-05175157 200 mg Twice a Day - Part B   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   6   7   19 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.7  (9.5)   49.3  (9.2)   55.1  (4.6)   51.9  (7.9) 
Gender, Customized 
[Units: Participants]
       
Male   5   5   5   15 
Female   1   1   2   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glucose Infusion Rates (GIR) in Part A   [ Time Frame: 1 day ]

2.  Primary:   Endogenous Gucose Production (EGP) in Part A   [ Time Frame: 1 day ]

3.  Primary:   [6,6-2H2] Plasma Glucose Enrichment (PGE) in Part A   [ Time Frame: 1 day ]

4.  Primary:   Rate of Appearance of Glucose (Ra) in Part A   [ Time Frame: 1 day ]

5.  Primary:   Whole-body Glucose Uptake in Part A   [ Time Frame: 1 day ]

6.  Primary:   Whole-body Glucose Uptake in Part B in Placebo Group   [ Time Frame: 6 weeks ]

7.  Primary:   Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group   [ Time Frame: 6 weeks ]

8.  Primary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B   [ Time Frame: Baseline to follow-up (up to approximately 10 to 14 days after the last study drug administration) ]

9.  Primary:   Number of Participants With Laboratory Test Abnormalities in Part B   [ Time Frame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration) ]

10.  Primary:   Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria in Part B   [ Time Frame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration) ]

11.  Primary:   Number of Participants With Change From Baseline and Absolute Values in Electrocardiogram (ECG) Meeting Categorical Summarisation Criteria in Part B   [ Time Frame: Screening up to follow-up (up to approximately 10 to 14 days after the last study drug administration) ]

12.  Secondary:   GIR in Part B in Placebo Group   [ Time Frame: 6 weeks ]

13.  Secondary:   GIR in Part B in PF-05175157 200 mg BID Group   [ Time Frame: 6 weeks ]

14.  Secondary:   EGP in Part B in Placebo Group   [ Time Frame: 6 weeks ]

15.  Secondary:   EGP in Part B in PF-05175157 200 mg BID Group   [ Time Frame: 6 weeks ]

16.  Secondary:   Ra in Part B in Placebo Group   [ Time Frame: 6 weeks ]

17.  Secondary:   Ra in Part B in PF-05175157 200 mg BID Group   [ Time Frame: 6 weeks ]


  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
Part B of the study was terminated due to the safety issue. Due to the low number of participants who completed the study, there are no conclusions for PK or PD in Part B. The prioritization of Part A endpoints was done by inputs from team.


  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 ClnicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01792635     History of Changes
Other Study ID Numbers: B1731003
Study First Received: December 20, 2012
Results First Received: January 11, 2016
Last Updated: December 22, 2016