Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intarcia Therapeutics
ClinicalTrials.gov Identifier:
NCT00943917
First received: July 20, 2009
Last updated: November 13, 2012
Last verified: November 2012
Results First Received: February 24, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Other: ITCA 650
Drug: Exenatide Injection
Other: Ex Inj/ITCA 650

  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
At Stage II subjects divided into 6 total arms: ITCA 650 20 mcg/day assigned to either ITCA 650 20 mcg/day or ITCA 650 40 mcg/day; ITCA 650 40 mcg/day assigned to ITCA 650 40 mcg/day or ITCA 650 80 mcg/day; Ex Inj assigned to either ITCA 650 40 mcg/day or ITCA 650 60 mcg/day

Reporting Groups
  Description
ITCA 650 20 Mcg/Day- STAGE I ITCA 650 20 mcg/day continuous exenatide
ITCA 650 40 Mcg/Day- STAGE I ITCA 650 40 mcg/day continuous exenatide
Exenatide Injection- STAGE I exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
ITCA 650 20/20- STAGE II ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
ITCA 650 20/60- STAGE II ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
ITCA 650 40/40 - STAGE II ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
ITCA 650 40/80 - STAGE II ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
Ex Inj/ITCA 650 40 Mcg/Day- STAGE II Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
Ex Inj/ITCA 650 60 Mcg/Day- STAGE II Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
ITCA 650 20/20 Continuation ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
ITCA 650 20/40 Continuation ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
ITCA 650 40/40 Contination ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
ITCA 650 40/80 Continuation ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
Ex Inj/ITCA 650 40 Continuation Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
Ex Inj/ITCA 650 60 Continuation Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48

Participant Flow for 3 periods

Period 1:   Stage I
    ITCA 650 20 Mcg/Day- STAGE I     ITCA 650 40 Mcg/Day- STAGE I     Exenatide Injection- STAGE I     ITCA 650 20/20- STAGE II     ITCA 650 20/60- STAGE II     ITCA 650 40/40 - STAGE II     ITCA 650 40/80 - STAGE II     Ex Inj/ITCA 650 40 Mcg/Day- STAGE II     Ex Inj/ITCA 650 60 Mcg/Day- STAGE II     ITCA 650 20/20 Continuation     ITCA 650 20/40 Continuation     ITCA 650 40/40 Contination     ITCA 650 40/80 Continuation     Ex Inj/ITCA 650 40 Continuation     Ex Inj/ITCA 650 60 Continuation  
STARTED     51     51     53     0     0     0     0     0     0     0     0     0     0     0     0  
COMPLETED     47     48     47     0     0     0     0     0     0     0     0     0     0     0     0  
NOT COMPLETED     4     3     6     0     0     0     0     0     0     0     0     0     0     0     0  
Adverse Event                 1                 2                 2                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Lost to Follow-up                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
hyperglycemia                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
A1C elevation                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 2                 1                 2                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0  

Period 2:   Stage II
    ITCA 650 20 Mcg/Day- STAGE I     ITCA 650 40 Mcg/Day- STAGE I     Exenatide Injection- STAGE I     ITCA 650 20/20- STAGE II     ITCA 650 20/60- STAGE II     ITCA 650 40/40 - STAGE II     ITCA 650 40/80 - STAGE II     Ex Inj/ITCA 650 40 Mcg/Day- STAGE II     Ex Inj/ITCA 650 60 Mcg/Day- STAGE II     ITCA 650 20/20 Continuation     ITCA 650 20/40 Continuation     ITCA 650 40/40 Contination     ITCA 650 40/80 Continuation     Ex Inj/ITCA 650 40 Continuation     Ex Inj/ITCA 650 60 Continuation  
STARTED     0     0     0     20     21     23     23     23     21     0     0     0     0     0     0  
COMPLETED     0     0     0     20     21     20     20     23     20     0     0     0     0     0     0  
NOT COMPLETED     0     0     0     0     0     3     3     0     1     0     0     0     0     0     0  
Adverse Event                 0                 0                 0                 0                 0                 1                 3                 0                 1                 0                 0                 0                 0                 0                 0  
Withdrawal by Subject                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Pregnancy                 0                 0                 0                 0                 0                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0  

Period 3:   Stage II Continuation
    ITCA 650 20 Mcg/Day- STAGE I     ITCA 650 40 Mcg/Day- STAGE I     Exenatide Injection- STAGE I     ITCA 650 20/20- STAGE II     ITCA 650 20/60- STAGE II     ITCA 650 40/40 - STAGE II     ITCA 650 40/80 - STAGE II     Ex Inj/ITCA 650 40 Mcg/Day- STAGE II     Ex Inj/ITCA 650 60 Mcg/Day- STAGE II     ITCA 650 20/20 Continuation     ITCA 650 20/40 Continuation     ITCA 650 40/40 Contination     ITCA 650 40/80 Continuation     Ex Inj/ITCA 650 40 Continuation     Ex Inj/ITCA 650 60 Continuation  
STARTED     0     0     0     0     0     0     0     0     0     15     15     13     16     15     12  
COMPLETED     0     0     0     0     0     0     0     0     0     14     15     11     13     12     8  
NOT COMPLETED     0     0     0     0     0     0     0     0     0     1     0     2     3     3     4  
Adverse Event                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 2                 1                 1  
Withdrawal by Subject                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 3  
Protocol Violation                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 1                 0                 0                 0  
hypoglycemia                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 1                 0                 0  
A1C elevation                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 0                 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.
No text entered.

Reporting Groups
  Description
ITCA 650 20 Mcg/Day- STAGE I ITCA 650 20 mcg/day continuous exenatide
ITCA 650 40 Mcg/Day- STAGE I ITCA 650 40 mcg/day continuous exenatide
Exenatide Injection- STAGE I exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
ITCA 650 20/20- STAGE II ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
ITCA 650 20/60- STAGE II ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
ITCA 650 40/40 - STAGE II ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
ITCA 650 40/80 - STAGE II ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
Ex Inj/ITCA 650 40 Mcg/Day- STAGE II Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
Ex Inj/ITCA 650 60 Mcg/Day- STAGE II Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
ITCA 650 20/20 Continuation ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
ITCA 650 20/40 Continuation ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
ITCA 650 40/40 Contination ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
ITCA 650 40/80 Continuation ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
Ex Inj/ITCA 650 40 Continuation Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
Ex Inj/ITCA 650 60 Continuation Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
Total Total of all reporting groups

Baseline Measures
    ITCA 650 20 Mcg/Day- STAGE I     ITCA 650 40 Mcg/Day- STAGE I     Exenatide Injection- STAGE I     ITCA 650 20/20- STAGE II     ITCA 650 20/60- STAGE II     ITCA 650 40/40 - STAGE II     ITCA 650 40/80 - STAGE II     Ex Inj/ITCA 650 40 Mcg/Day- STAGE II     Ex Inj/ITCA 650 60 Mcg/Day- STAGE II     ITCA 650 20/20 Continuation     ITCA 650 20/40 Continuation     ITCA 650 40/40 Contination     ITCA 650 40/80 Continuation     Ex Inj/ITCA 650 40 Continuation     Ex Inj/ITCA 650 60 Continuation     Total  
Number of Participants  
[units: participants]
  51     51     53     0     0     0     0     0     0     0     0     0     0     0     0     155  
Age  
[units: years]
Mean ± Standard Deviation
  54.0  ± 8.3     53.3  ± 8.9     53.8  ± 9.6                                                     53.7  ± 8.9  
Age, Customized  
[units: participants]
                               
<=18 years     0     0     0                                                     0  
Between 18 and 60 years     41     37     39                                                     117  
>=60 years     10     14     14                                                     38  
Gender  
[units: participants]
                               
Female     26     28     24                                                     78  
Male     25     23     29                                                     77  
Region of Enrollment  
[units: participants]
                               
United States     51     51     53                                                     155  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in HbA1c (Per Protocol)   [ Time Frame: Day 0 and Week 12 ]

2.  Primary:   Mean Change in HbA1c (ITT)   [ Time Frame: Day 0 to Week 12 ]

3.  Primary:   Mean Change in HbA1c (Per Protocol)   [ Time Frame: Day 0 to Week 24 ]

4.  Primary:   Mean Change in HbA1c (ITT)   [ Time Frame: Day 0 to Week 24 ]

5.  Primary:   Mean Change in HbA1c (Per Protocol)   [ Time Frame: Day 0 to Week 48 ]

6.  Primary:   Mean Change in HbA1c (ITT)   [ Time Frame: Day 0 to Week 48 ]


  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
8 subjects (4 in 20, 1 in 40 and 3 in ex inj)completed StI but not randomized to St II; 3 subjects (2 in 20/20 & 1 in 40/80) who completed St I, randomized to St II but not given study drug. St II Cont was optional, so not all pts elected to continue


  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: Michelle Baron MD
Organization: Intarcia Therapeutics, Inc
phone: 510-782-7800
e-mail: clinicaltrials@intarcia.com


No publications provided by Intarcia Therapeutics

Publications automatically indexed to this study:

Responsible Party: Intarcia Therapeutics
ClinicalTrials.gov Identifier: NCT00943917     History of Changes
Other Study ID Numbers: ITCA 650-CLP-02
Study First Received: July 20, 2009
Results First Received: February 24, 2012
Last Updated: November 13, 2012
Health Authority: United States: Food and Drug Administration