Multiple Dose Study Of PF-05231023 In Adult Subjects Who Have Poor Lipid Control With And Without Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01673178
First received: August 22, 2012
Last updated: January 28, 2015
Last verified: January 2015
Results First Received: January 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Melliuts, Type 2
Interventions: Other: Placebo
Drug: 25 mg PF-05231023
Drug: 50 mg PF-05231023
Drug: 100 mg PF-05231023
Drug: 150 mg PF-05231023

  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
Placebo Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 mg PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.

Participant Flow:   Overall Study
    Placebo     PF-05231023 25 mg     PF-05231023 50 mg     PF-05231023 100 mg     PF-05231023 150 mg  
STARTED     22     21     21     22     21  
COMPLETED     19     19     18     14     19  
NOT COMPLETED     3     2     3     8     2  
Lost to Follow-up                 0                 1                 0                 0                 0  
Withdrawal by Subject                 0                 0                 1                 4                 2  
Protocol Violation                 1                 1                 0                 1                 0  
Adverse Event                 1                 0                 0                 2                 0  
Unspecified                 1                 0                 2                 1                 0  



  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.
Analysis set included all participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Placebo Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 25 mg PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 50 mg PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 100 mg PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
PF-05231023 150 mg PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
Total Total of all reporting groups

Baseline Measures
    Placebo     PF-05231023 25 mg     PF-05231023 50 mg     PF-05231023 100 mg     PF-05231023 150 mg     Total  
Number of Participants  
[units: participants]
  22     21     21     22     21     107  
Age  
[units: years]
Mean (Standard Deviation)
  52.8  (8.0)     54.6  (8.3)     53.4  (9.5)     53.0  (7.4)     53.2  (8.0)     53.4  (8.1)  
Gender  
[units: participants]
           
Female     11     7     4     5     4     31  
Male     11     14     17     17     17     76  



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

2.  Primary:   Number of Participants With Laboratory Abnormalities   [ Time Frame: Baseline up to Day 49 ]

3.  Primary:   Number of Participants With Clinically Significant Vital Sign Abnormalities   [ Time Frame: Baseline up to Day 49 ]

4.  Primary:   Number of Participants With Clinically Significant Electrocardiogram Findings   [ Time Frame: Baseline up to Day 49 ]

5.  Primary:   Number of Participants With Abnormal Physical Examinations   [ Time Frame: Baseline up to Day 49 ]

6.  Primary:   Thyroid Stimulating Hormone (TSH) Level at Baseline   [ Time Frame: Baseline ]

7.  Primary:   Thyroid Stimulating Hormone (TSH) Level at Day 1   [ Time Frame: Day 1 ]

8.  Primary:   Thyroid Stimulating Hormone (TSH) Level at Day 25   [ Time Frame: Day 25 ]

9.  Primary:   Thyroid Stimulating Hormone (TSH) Level at Day 39   [ Time Frame: Day 39 ]

10.  Primary:   Thyroid Stimulating Hormone (TSH) Level at Day 49   [ Time Frame: Day 49 ]

11.  Primary:   Phosphate Level at Baseline   [ Time Frame: Baseline ]

12.  Primary:   Change From Baseline in Phosphate Level at Day 8   [ Time Frame: Baseline, Day 8 ]

13.  Primary:   Change From Baseline in Phosphate Level at Day 15   [ Time Frame: Baseline, Day 15 ]

14.  Primary:   Change From Baseline in Phosphate Level at Day 25   [ Time Frame: Baseline, Day 25 ]

15.  Primary:   Change From Baseline in Phosphate Level at Day 49   [ Time Frame: Baseline, Day 49 ]

16.  Primary:   Creatine Phosphokinase (CPK) Level at Baseline   [ Time Frame: Baseline ]

17.  Primary:   Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 8   [ Time Frame: Baseline, Day 8 ]

18.  Primary:   Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 15   [ Time Frame: Baseline, Day 15 ]

19.  Primary:   Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 25   [ Time Frame: Baseline, Day 25 ]

20.  Primary:   Change From Baseline in Creatine Phosphokinase (CPK) Level at Day 49   [ Time Frame: Baseline, Day 49 ]

21.  Primary:   Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Baseline   [ Time Frame: Baseline ]

22.  Primary:   Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 25   [ Time Frame: Baseline, Day 25 ]

23.  Primary:   Percent Change From Baseline in Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 39   [ Time Frame: Baseline, Day 39 ]

24.  Primary:   Percent Change From Baseline Serum N-terminal Propeptides of Type 1 Collagen (PINP) and C-Telopeptide Cross-Linking of Type 1 Collagen (CTX) Levels at Day 49   [ Time Frame: Baseline, Day 49 ]

25.  Primary:   Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Baseline   [ Time Frame: Baseline ]

26.  Primary:   Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 25   [ Time Frame: Baseline, Day 25 ]

27.  Primary:   Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 39   [ Time Frame: Baseline, Day 39 ]

28.  Primary:   Percent Change From Baseline in Blood Osteocalcin and Bone-Specific Alkaline Phosphatase Levels at Day 49   [ Time Frame: Baseline, Day 49 ]

29.  Primary:   Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Baseline   [ Time Frame: Baseline ]

30.  Primary:   Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 25   [ Time Frame: Baseline, Day 25 ]

31.  Primary:   Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 39   [ Time Frame: Baseline, Day 39 ]

32.  Primary:   Percent Change From Baseline in Tartrate-resistant Acid Phosphatase Isoform 5b (TRAP 5b) Levels at Day 49   [ Time Frame: Day 49 ]

33.  Primary:   Average Urinary Calcium and Phosphate Levels Over 24 Hours at Baseline   [ Time Frame: Baseline ]

34.  Primary:   Change From Baseline in Average Urinary Calcium and Phosphate Levels Over 24 Hours at Day 24   [ Time Frame: Day 24 ]

35.  Primary:   Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 1   [ Time Frame: Day 1 ]

36.  Primary:   Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 39   [ Time Frame: Day 39 ]

37.  Primary:   Number of Participants With Anti-PF-05231023 Antibodies and Neutralizing Antibodies at Day 49   [ Time Frame: Day 49 ]

38.  Secondary:   Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Single Dose   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hours (pre-dose) on Day 8 ]

39.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Single Dose   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8 ]

40.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Single Dose   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1, Day 4, 0 hour (pre-dose) on Day 8 ]

41.  Secondary:   Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-05231023 After Last Dose   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29 ]

42.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023 After Last Dose   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 ]

43.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of PF-05231023 After Last Dose   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 ]

44.  Secondary:   Accumulation Ratio for Area Under the Curve From Time Zero to End of Dosing Interval (Rac) of PF-05231023   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion ), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24, 25, 29 ]

45.  Secondary:   Accumulation Ratio for Maximum Observed Plasma Concentration (Rac,Cmax) of PF-05231023   [ Time Frame: 0 (pre-dose),0.5(end of infusion), 1, 2.5, 3.5, 5.5, 9.5, 11.5 hours after start of infusion on Day 1; Day 4, 0 hour (pre-dose) on Day 8; 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22; Day 24,25,29,39,49 ]

46.  Secondary:   Minimum Observed Plasma Trough Concentration (Cmin) of PF-05231023 After Last Dose   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 ]

47.  Secondary:   Average Plasma Concentration (Cav ) of PF-05231023 After the Last Dose   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 ]

48.  Secondary:   Plasma Decay Half-Life (t1/2) of PF-05231023   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 ]

49.  Secondary:   Apparent Clearance (CL) of PF-05231023   [ Time Frame: 0 (pre-dose), 0.5 (end of infusion), 1, 2.5, 3.5, 4.5 hours after start of infusion on Day 22, Day 24, 25, 29, 39, 49 ]


  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


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01673178     History of Changes
Other Study ID Numbers: B2901011
Study First Received: August 22, 2012
Results First Received: January 6, 2015
Last Updated: January 28, 2015
Health Authority: United States: Food and Drug Administration