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A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00886821
First received: April 22, 2009
Last updated: March 6, 2017
Last verified: March 2017
Results First Received: March 2, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Intervention: Biological: CVX-096

  Participant Flow
  Hide 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
Study consist of two stages: stage 1 and stage 2. Participants were enrolled and randomized for stage 1 and stage 2 separately.

Reporting Groups
  Description
Cohort 1: PF-04856883 0.1 Milligram (mg) Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
Cohort 2: PF-04856883 0.3 mg Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
Cohort 3: PF-04856883 1.0 mg Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
Cohort 4: PF-04856883 3.0 mg Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
Cohort 5: PF-04856883 6.0 mg Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
Cohort 6: PF-04856883 12.0 mg Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
Cohort 7: PF-04856883 24.0 mg Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
Cohort 8: PF-04856883 36.0 mg Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
Cohort 9: PF-04856883 18.0 mg Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
Cohort 1-9: Placebo Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
Cohort 10: PF-04856883 15.0 mg Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
Cohort 11: PF-04856883 20.0 mg Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
Cohort 12: PF-04856883 25.0 mg Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
Cohort 10-12: Placebo Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.

Participant Flow for 2 periods

Period 1:   Stage 1
    Cohort 1: PF-04856883 0.1 Milligram (mg)   Cohort 2: PF-04856883 0.3 mg   Cohort 3: PF-04856883 1.0 mg   Cohort 4: PF-04856883 3.0 mg   Cohort 5: PF-04856883 6.0 mg   Cohort 6: PF-04856883 12.0 mg   Cohort 7: PF-04856883 24.0 mg   Cohort 8: PF-04856883 36.0 mg   Cohort 9: PF-04856883 18.0 mg   Cohort 1-9: Placebo   Cohort 10: PF-04856883 15.0 mg   Cohort 11: PF-04856883 20.0 mg   Cohort 12: PF-04856883 25.0 mg   Cohort 10-12: Placebo
STARTED   7   6   6   7   6   6   6   6   6   18   0   0   0   0 
COMPLETED   7   6   6   7   6   6   6   6   6   18   0   0   0   0 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   0   0   0 

Period 2:   Stage 2
    Cohort 1: PF-04856883 0.1 Milligram (mg)   Cohort 2: PF-04856883 0.3 mg   Cohort 3: PF-04856883 1.0 mg   Cohort 4: PF-04856883 3.0 mg   Cohort 5: PF-04856883 6.0 mg   Cohort 6: PF-04856883 12.0 mg   Cohort 7: PF-04856883 24.0 mg   Cohort 8: PF-04856883 36.0 mg   Cohort 9: PF-04856883 18.0 mg   Cohort 1-9: Placebo   Cohort 10: PF-04856883 15.0 mg   Cohort 11: PF-04856883 20.0 mg   Cohort 12: PF-04856883 25.0 mg   Cohort 10-12: Placebo
STARTED   0   0   0   0   0   0   0   0   0   0   9   9   13   9 
COMPLETED   0   0   0   0   0   0   0   0   0   0   9   8   8   8 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0   0   1   5   1 
Adverse Event                0                0                0                0                0                0                0                0                0                0                0                1                3                0 
Lost to Follow-up                0                0                0                0                0                0                0                0                0                0                0                0                2                1 



  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.
Safety population included all randomized participants who received at least 1 dose of study medication.

Reporting Groups
  Description
Cohort 1: PF-04856883 0.1 Milligram (mg) Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
Cohort 2: PF-04856883 0.3 mg Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
Cohort 3: PF-04856883 1.0 mg Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
Cohort 4: PF-04856883 3.0 mg Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
Cohort 5: PF-04856883 6.0 mg Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
Cohort 6: PF-04856883 12.0 mg Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
Cohort 7: PF-04856883 24.0 mg Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
Cohort 8: PF-04856883 36.0 mg Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
Cohort 9: PF-04856883 18.0 mg Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
Cohort 9: Placebo Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or two dose on Day 1 and 8 respectively.
Cohort 10: PF-04856883 15.0 mg Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
Cohort 11: PF-04856883 20.0 mg Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
Cohort 12: PF-04856883 25.0 mg Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
Cohort 10-12: Placebo Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
Total Total of all reporting groups

Baseline Measures
   Cohort 1: PF-04856883 0.1 Milligram (mg)   Cohort 2: PF-04856883 0.3 mg   Cohort 3: PF-04856883 1.0 mg   Cohort 4: PF-04856883 3.0 mg   Cohort 5: PF-04856883 6.0 mg   Cohort 6: PF-04856883 12.0 mg   Cohort 7: PF-04856883 24.0 mg   Cohort 8: PF-04856883 36.0 mg   Cohort 9: PF-04856883 18.0 mg   Cohort 9: Placebo   Cohort 10: PF-04856883 15.0 mg   Cohort 11: PF-04856883 20.0 mg   Cohort 12: PF-04856883 25.0 mg   Cohort 10-12: Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   6   6   7   6   6   6   6   6   18   9   9   13   9   114 
Age 
[Units: Participants]
Count of Participants
                             
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7 100.0%      6 100.0%      6 100.0%      7 100.0%      6 100.0%      5  83.3%      5  83.3%      4  66.7%      5  83.3%      13  72.2%      8  88.9%      8  88.9%      13 100.0%      8  88.9%      101  88.6% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      1  16.7%      1  16.7%      2  33.3%      1  16.7%      5  27.8%      1  11.1%      1  11.1%      0   0.0%      1  11.1%      13  11.4% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                             
Female      0   0.0%      3  50.0%      1  16.7%      5  71.4%      3  50.0%      2  33.3%      5  83.3%      6 100.0%      0   0.0%      3  16.7%      4  44.4%      4  44.4%      3  23.1%      0   0.0%      39  34.2% 
Male      7 100.0%      3  50.0%      5  83.3%      2  28.6%      3  50.0%      4  66.7%      1  16.7%      0   0.0%      6 100.0%      15  83.3%      5  55.6%      5  55.6%      10  76.9%      9 100.0%      75  65.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Stage 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04856883 on Day 1   [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1 ]

2.  Primary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 1   [ Time Frame: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1 ]

3.  Primary:   Stage 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 8   [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 ]

4.  Primary:   Stage 2: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04856883 on Day 22   [ Time Frame: pre-dose, 1 and 6 hours post-dose on Day 22 ]

5.  Primary:   Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 1   [ Time Frame: Cohort 1-9: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1; Cohort 10-12: pre-dose, 1 and 6 hours post-dose on Day 1 ]

6.  Primary:   Stage 1: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 8   [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 ]

7.  Primary:   Stage 2: Maximum Observed Plasma Concentration (Cmax) of PF-04856883 on Day 22   [ Time Frame: pre-dose, 1 and 6 hours post-dose on Day 22 ]

8.  Secondary:   Stage 1: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 1   [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 1 ]

9.  Secondary:   Stage 1: Apparent Terminal Half-Life (t1/2) of PF-04856883 on Day 8   [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose on Day 8 ]

10.  Secondary:   Stage 2: Apparent Terminal Elimination Half-Life (t1/2) of PF-04856883 on Day 22   [ Time Frame: pre-dose, 1 and 6 hours post-dose on Day 22 ]

11.  Secondary:   Stage 1: Mean Residence Time (MRT) of PF-04856883 on Day 1   [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 ]

12.  Secondary:   Stage 1: Apparent Oral Clearance (CL/F) of PF-04856883 on Day 1   [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 ]

13.  Secondary:   Stage 1: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0 - Inf]) of PF-04856883 on Day 1   [ Time Frame: pre-dose, 1, 6, 18, 24, 36, 48, 72, 96, 144, and 168 hours post-dose Day 1 ]

14.  Other Pre-specified:   Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Cohort 1-8: Baseline up to Day 29; Cohort 9: Baseline up to Day 36; Cohort 10-12: Baseline up to Day 50 ]

15.  Other Pre-specified:   Stage 1: Change From Baseline in Post-Prandial Area Under the Curve (AUC) of Glucose at Day 3 and 7   [ Time Frame: Baseline, Day 3 and 7 ]

16.  Other Pre-specified:   Stage 1: Change From Baseline in 7-point Weighted Mean Glucose at Day 3 and Day 7   [ Time Frame: Baseline, Day 3 and 7 ]

17.  Other Pre-specified:   Number of Participants With Clinically Significant Laboratory Abnormalities   [ Time Frame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 ]

18.  Other Pre-specified:   Number of Participants With Clinically Significant Vital Signs   [ Time Frame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 ]

19.  Other Pre-specified:   Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings   [ Time Frame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 ]

20.  Other Pre-specified:   Number of Participants With Clinically Significant Physical Examinations   [ Time Frame: Cohort 1-8: Baseline up to Day 28; Cohort 9: Baseline up to Day 35; Cohort 10-12; Baseline up to Day 50 ]

21.  Other Pre-specified:   Stage 1: Number of Participants With Hypoglycemia   [ Time Frame: Day 1: 0 hour (pre-dose) up to 48 hours post dose ]

22.  Other Pre-specified:   Stage 1: Number of Participants With Clinically Significant Abnormal Rhythms   [ Time Frame: Cohort 1- 8: Day 1 up to Day 3; Cohort 9: Day 1 up to Day 10 ]

23.  Other Pre-specified:   Stage 1: Number of Participants With Anti-Drug Antibodies   [ Time Frame: Day 0, 8, 14, 15, 21, 28 and 35 ]

24.  Other Pre-specified:   Stage 2: Number of Participants With Anti-Drug Antibodies   [ Time Frame: Day 0, 29 and 50 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
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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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00886821     History of Changes
Other Study ID Numbers: B1111001
CVX-096-101 ( Other Identifier: Alias Study Number )
Study First Received: April 22, 2009
Results First Received: March 2, 2017
Last Updated: March 6, 2017