Study of ITCA 650 (Exenatide in DUROS) in Subjects With T... | NCT00943917 | Trialant
NCT00943917
Sponsor
Intarcia Therapeutics
Status
Completed
Last Update Posted
Apr 13, 2015Estimated
Enrollment
155Actual
Phase
Phase 2
Conditions
Type 2 Diabetes
Interventions
ITCA 650
Exenatide Injection
Ex Inj/ITCA 650
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00943917
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ITCA 650-CLP-02
Secondary IDs
Not provided
Brief Title
Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
Official Title
Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus
Acronym
Not provided
Organization
Intarcia TherapeuticsINDUSTRY
Status Module
Record Verification Date
Mar 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2009
Primary Completion Date
Aug 2010Actual
Completion Date
Feb 2011Actual
First Submitted Date
Jul 20, 2009
First Submission Date that Met QC Criteria
Jul 21, 2009
First Posted Date
Jul 22, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 24, 2012
Results First Submitted that Met QC Criteria
May 1, 2012
Results First Posted Date
May 3, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 23, 2015
Last Update Posted Date
Apr 13, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Intarcia TherapeuticsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.
Detailed Description
Not provided
Conditions Module
Conditions
Type 2 Diabetes
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
155Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ITCA 650 20 mcg/day
Experimental
Other: ITCA 650
ITCA 650 40 mcg/day
Experimental
Other: ITCA 650
Exenatide Injection
Active Comparator
Drug: Exenatide Injection
ITCA 650 20/20
Experimental
Other: ITCA 650
ITCA 650 20/60
Experimental
Other: ITCA 650
ITCA 650 40/40
Experimental
Other: ITCA 650
ITCA 650 40/80
Experimental
Other: ITCA 650
Ex Inj/ITCA 650 40
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ITCA 650
Other
ITCA 650 (continuous delivery of exenatide in DUROS)
ITCA 650 20 mcg/day
ITCA 650 20/20
ITCA 650 20/60
ITCA 650 40 mcg/day
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c over first 12 weeks (Stage I)
Day 0 and Week 12
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 12
Day 0 to Week 12
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c through Week 24
Day 0 to Week 24
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 24
Day 0 to Week 24
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c through Week 48
Day 0 to Week 48
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 48
Day 0 to Week 48
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Males or females age 18-70 years
Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
Fasting plasma glucose < 240 mg/dL at Screening Visit 1
HbA1c ≥ 7% and ≤ 10% at Screening Visit 1
Exclusion Criteria:
Prior treatment with exenatide
Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
History of type 1 diabetes and/or history of diabetic ketoacidosis
Henry RR, Rosenstock J, Logan DK, Alessi TR, Luskey K, Baron MA. Randomized trial of continuous subcutaneous delivery of exenatide by ITCA 650 versus twice-daily exenatide injections in metformin-treated type 2 diabetes. Diabetes Care. 2013 Sep;36(9):2559-65. doi: 10.2337/dc12-2410. Epub 2013 May 3.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
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
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
ITCA 650 20 mcg/Day- STAGE I
ITCA 650 20 mcg/day continuous exenatide
FG001
ITCA 650 40 mcg/Day- STAGE I
ITCA 650 40 mcg/day continuous exenatide
Periods
Title
Milestones
Reasons Not Completed
Stage I
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Other: Ex Inj/ITCA 650
Ex Inj/ITCA 650 60
Experimental
Other: Ex Inj/ITCA 650
ITCA 650 40/40
ITCA 650 40/80
Exenatide Injection
Drug
twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks
Exenatide Injection
Byetta
Ex Inj/ITCA 650
Other
twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650
Ex Inj/ITCA 650 40
Ex Inj/ITCA 650 60
Byetta
La Jolla
California
92037
United States
Study Site
National City
California
91950
United States
Study Site
Sacramento
California
95821
United States
Study Site
San Diego
California
92161
United States
Study Site
Valley Village
California
91607
United States
Study Site
Longmont
Colorado
80501
United States
Study Site
Pueblo
Colorado
81001
United States
Study Site
Bradenton
Florida
34203
United States
Study Site
Miami
Florida
33143
United States
Study Site
Miami
Florida
33169
United States
Study Site
Miami
Florida
33183
United States
Study Site
Miramar
Florida
33025
United States
Study Site
Pembroke Pines
Florida
33026
United States
Study Site
St. Petersburg
Florida
33709
United States
Study Site
Atlanta
Georgia
30342
United States
Study Site
Sandy Springs
Georgia
30328
United States
Study Site
Meridian
Idaho
83642
United States
Study Site
Chicago
Illinois
60607
United States
Study Site
Avon
Indiana
46123
United States
Study Site
Wichita
Kansas
67205
United States
Study Site
Lexington
Kentucky
40503
United States
Study Site
New Orleans
Louisiana
70112
United States
Study Site
Kalamazoo
Michigan
49007
United States
Study Site
Traverse City
Michigan
49684
United States
Study Site
Troy
Michigan
48098
United States
Study Site
Ypsilanti
Michigan
48197
United States
Study Site
Minneapolis
Minnesota
55416
United States
Study Site
Las Vegas
Nevada
89119
United States
Study Site
New Hyde Park
New York
11042
United States
Study Site
Charlotte
North Carolina
28209
United States
Study Site
Hickory
North Carolina
28601
United States
Study Site
Cincinnati
Ohio
45212
United States
Study Site
Cincinnati
Ohio
45219
United States
Study Site
Franklin
Ohio
45005
United States
Study Site
Kettering
Ohio
45429
United States
Study Site
Norman
Oklahoma
73069
United States
Study Site
Eugene
Oregon
97404
United States
Study Site
Rapid City
South Dakota
57702
United States
Study Site
Austin
Texas
78749
United States
Study Site
Austin
Texas
78752
United States
Study Site
Dallas
Texas
75230
United States
Study Site
Dallas
Texas
75251
United States
Study Site
Irving
Texas
75039
United States
Study Site
San Antonio
Texas
78205
United States
Study Site
San Antonio
Texas
78229
United States
Study Site
West Jordan
Utah
84088
United States
Study Site
Norfolk
Virginia
23502
United States
Study Site
Olympia
Washington
98502
United States
Study Site
Spokane
Washington
99202
United States
FG002
Exenatide Injection- STAGE I
exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
FG003
ITCA 650 20/20- STAGE II
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
FG004
ITCA 650 20/60- STAGE II
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
FG005
ITCA 650 40/40 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
FG006
ITCA 650 40/80 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
FG007
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
FG008
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
FG009
ITCA 650 20/20 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
FG010
ITCA 650 20/40 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
FG011
ITCA 650 40/40 Contination
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
FG012
ITCA 650 40/80 Continuation
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
FG013
Ex Inj/ITCA 650 40 Continuation
Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
FG014
Ex Inj/ITCA 650 60 Continuation
Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
FG00051 subjects
FG00151 subjects
FG00253 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG00047 subjects
FG00148 subjects
FG00247 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
NOT COMPLETED
FG0004 subjects
FG0013 subjects
FG0026 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
hyperglycemia
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
A1C elevation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Stage II
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00320 subjects
FG00421 subjects
FG00523 subjects
FG00623 subjects
FG00723 subjects
FG00821 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00320 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Stage II Continuation
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00915 subjects
FG01015 subjects
FG01113 subjects
FG01216 subjects
FG01315 subjects
FG01412 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
ITCA 650 20 mcg/Day- STAGE I
ITCA 650 20 mcg/day continuous exenatide
BG001
ITCA 650 40 mcg/Day- STAGE I
ITCA 650 40 mcg/day continuous exenatide
BG002
Exenatide Injection- STAGE I
exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
BG003
ITCA 650 20/20- STAGE II
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
BG004
ITCA 650 20/60- STAGE II
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
BG005
ITCA 650 40/40 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
BG006
ITCA 650 40/80 - STAGE II
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
BG007
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
BG008
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
BG009
ITCA 650 20/20 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
BG010
ITCA 650 20/40 Continuation
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
BG011
ITCA 650 40/40 Contination
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
BG012
ITCA 650 40/80 Continuation
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
BG013
Ex Inj/ITCA 650 40 Continuation
Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
BG014
Ex Inj/ITCA 650 60 Continuation
Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00051
BG00151
BG00253
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG015155
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054.0± 8.3
BG00153.3± 8.9
BG00253.8± 9.6
BG015
Age, Customized
Number
participants
Title
Denominators
Categories
<=18 years
Title
Measurements
BG0000
BG0010
BG002
Gender
Number
participants
Title
Denominators
Categories
Female
Title
Measurements
BG00026
BG00128
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00051
BG00151
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c over first 12 weeks (Stage I)
Per protocol analysis- Only subjects with values at baseline and Week 12 endpoint are included.
Posted
Mean
Standard Deviation
percent change
Day 0 and Week 12
ID
Title
Description
OG000
ITCA 650 20 mcg/Day - STAGE I
ITCA 650 20 mcg/day through Week 12
OG001
ITCA 650 40 mcg/Day - STAGE I
ITCA 650 40 mcg/day through Week 12
OG002
Exenatide Injection - STAGE I
Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
Units
Counts
Participants
OG00047
OG00145
OG00247
Title
Denominators
Categories
Title
Measurements
OG000-0.96± 0.905
OG001-1.04± 0.713
OG002-0.82± 0.870
Primary
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 12
Intent to treat analysis
Posted
Mean
Standard Deviation
percent change
Day 0 to Week 12
ID
Title
Description
OG000
ITCA 650 20 mcg/Day - STAGE I
ITCA 650 20 mcg/day through Week 12
OG001
ITCA 650 40 mcg/Day - STAGE I
ITCA 650 40 mcg/day through Week 12
OG002
Exenatide Injection - STAGE I
Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
Units
Counts
Participants
OG000
Primary
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c through Week 24
Per protocol analysis - Only subjects with values at baseline and Week 24 endpoint are included.
Posted
Mean
Standard Deviation
percent change
Day 0 to Week 24
ID
Title
Description
OG000
ITCA 650 20/20
Stage II & Stage II Continuation
OG001
ITCA 650 20/60
Stage II & Stage II Continuation
OG002
ITCA 650 40/40
Stage II & Stage II Continuation
OG003
ITCA 650 40/80
Stage II & Stage II Continuation
OG004
Ex Inj/ITCA 650 40
Stage II & Stage II Continuation
OG005
Primary
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 24
Intent to treat analysis
Posted
Mean
Standard Deviation
percent change
Day 0 to Week 24
ID
Title
Description
OG000
ITCA 650 20/20
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
OG001
ITCA 650 20/60
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
OG002
ITCA 650 40/40
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
OG003
ITCA 650 40/80
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
OG004
Ex Inj/ITCA 650 40
Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
Primary
Mean Change in HbA1c (Per Protocol)
Mean change in HbA1c through Week 48
Per protocol - Only subjects with values at baseline and Week 48 endpoint are included.
Posted
Mean
Standard Deviation
percent change
Day 0 to Week 48
ID
Title
Description
OG000
ITCA 650 20/20
Stage II Continuation
OG001
ITCA 650 20/60
Stage II & Stage II Continuation
OG002
ITCA 650 40/40
Stage II & Stage II Continuation
OG003
ITCA 650 40/80
Stage II & Stage II Continuation
OG004
Ex Inj/ITCA 650 40
Stage II & Stage II Continuation
OG005
Primary
Mean Change in HbA1c (ITT)
Mean change in HbA1c through Week 48
Intent to treat analysis
Posted
Mean
Standard Deviation
percent change
Day 0 to Week 48
ID
Title
Description
OG000
ITCA 650 20/20
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
OG001
ITCA 650 20/60
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
OG002
ITCA 650 40/40
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
OG003
ITCA 650 40/80
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
OG004
Ex Inj/ITCA 650 40
Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
Time Frame
48 weeks
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
ITCA 650 20 mcg/Day
ITCA 650 20 mcg/day continuous exenatide
1
51
39
51
EG001
ITCA 650 40 mcg/Day
ITCA 650 40 mcg/day continuous exenatide
0
51
43
51
EG002
Exenatide Injection
exenatide injection twice daily dosing: 5 mcg/dose first 4 weeks then 10 mcg/day next 8 weeks
0
53
38
53
EG003
ITCA 650 20/20
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
1
20
11
20
EG004
ITCA 650 20/60
ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
1
21
15
21
EG005
ITCA 650 40/40
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
2
23
18
23
EG006
ITCA 650 40/80
ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
2
23
18
23
EG007
Ex Inj/ITCA 650 40
Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
0
23
18
23
EG008
Ex Inj/ITCA 650 60
Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
0
21
18
21
EG009
ITCA 650 20/20 Continuation
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 48
0
15
2
15
EG010
ITCA 650 20/60 Continuation
ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 60 mcg/day through Week 48
1
15
3
15
EG011
ITCA 650 40/40 Continuation
ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
1
13
3
13
EG012
ITCA 650 40/80 Continuation
ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 80 mcg/day through Week 48
2
16
6
16
EG013
Ex Inj/ITCA 40 Continuation
Exenatide twice/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
0
15
4
15
EG014
Ex Inj/ITCA 650 60 Continutation
Exenatide injection first 12 weeks, then ITCA 650 60 mcg/day through Week 48
0
12
4
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
cholecyctitis acute
Hepatobiliary disorders
MedDra 12.0
Non-systematic Assessment
EG0001 events1 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG0030 events0 affected20 at risk
EG0040 events0 affected21 at risk
EG0050 events0 affected19 at risk
EG0060 events0 affected19 at risk
EG0070 events0 affected22 at risk
EG0080 events0 affected20 at risk
EG0090 events0 affected15 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected13 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected15 at risk
EG0140 events0 affected12 at risk
leukopenia
Blood and lymphatic system disorders
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
pyrexia
General disorders
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
meningitis cryptococcal
Infections and infestations
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
abortion, spontaneous
Pregnancy, puerperium and perinatal conditions
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
prostatomegaly
Reproductive system and breast disorders
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
skin ulcer
Skin and subcutaneous tissue disorders
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
myocardial infarction
Cardiac disorders
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
labyrinthitis
Infections and infestations
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
subclavian artery stenosis
Vascular disorders
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
abdominal pain upper
Gastrointestinal disorders
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
nausea
Gastrointestinal disorders
MedDra 12.0
Non-systematic Assessment
EG00019 events17 affected51 at risk
EG00124 events24 affected51 at risk
EG00220 events19 affected53 at risk
EG0032 events2 affected20 at risk
EG0048 events7 affected21 at risk
EG0051 events1 affected23 at risk
EG0067 events6 affected23 at risk
EG0071 events1 affected23 at risk
EG0089 events8 affected21 at risk
EG0090 events0 affected15 at risk
EG0100 events0 affected15 at risk
EG0110 events0 affected13 at risk
EG0120 events0 affected16 at risk
EG0130 events0 affected15 at risk
EG0140 events0 affected12 at risk
vomiting
Gastrointestinal disorders
MedDra 12.0
Non-systematic Assessment
EG0006 events6 affected51 at risk
EG00111 events9 affected51 at risk
EG0024 events4 affected53 at risk
EG003
diarrhea
Gastrointestinal disorders
MedDra 12.0
Non-systematic Assessment
EG0002 events2 affected51 at risk
EG0018 events8 affected51 at risk
EG0023 events3 affected53 at risk
EG003
gastroesophageal reflux disease (GERD)
Gastrointestinal disorders
MedDra 12.0
Non-systematic Assessment
EG0004 events4 affected51 at risk
EG0014 events4 affected51 at risk
EG0021 events1 affected53 at risk
EG003
constipation
Gastrointestinal disorders
MedDra 12.0
Non-systematic Assessment
EG0003 events3 affected51 at risk
EG0014 events4 affected51 at risk
EG0021 events1 affected53 at risk
EG003
dyspepsia
Gastrointestinal disorders
MedDra 12.0
Non-systematic Assessment
EG0004 events4 affected51 at risk
EG0011 events1 affected51 at risk
EG0023 events3 affected53 at risk
EG003
early satiety
General disorders
MedDra 12.0
Non-systematic Assessment
EG0002 events2 affected51 at risk
EG0013 events3 affected51 at risk
EG0024 events4 affected53 at risk
EG003
incision site hematoma
Injury, poisoning and procedural complications
MedDra 12.0
Non-systematic Assessment
EG0008 events8 affected51 at risk
EG0018 events8 affected51 at risk
EG0020 events0 affected53 at risk
EG003
incision site pruritis
Injury, poisoning and procedural complications
MedDra 12.0
Non-systematic Assessment
EG0003 events3 affected51 at risk
EG0017 events7 affected51 at risk
EG0020 events0 affected53 at risk
EG003
incision site hemorrhage
Injury, poisoning and procedural complications
MedDra 12.0
Non-systematic Assessment
EG0003 events3 affected51 at risk
EG0015 events5 affected51 at risk
EG0020 events0 affected53 at risk
EG003
decreased appetite
Metabolism and nutrition disorders
MedDra 12.0
Non-systematic Assessment
EG0006 events6 affected51 at risk
EG0017 events7 affected51 at risk
EG0025 events5 affected53 at risk
EG003
headache
Nervous system disorders
MedDra 12.0
Non-systematic Assessment
EG0002 events2 affected51 at risk
EG0016 events6 affected51 at risk
EG0021 events1 affected53 at risk
EG003
incision site pain
Injury, poisoning and procedural complications
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
incision site erythema
Injury, poisoning and procedural complications
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
incision site complication
Injury, poisoning and procedural complications
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
fatigue
General disorders
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
urinary tract infection
Infections and infestations
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
upper respiratory tract infection
Infections and infestations
MedDra 12.0
Non-systematic Assessment
EG0000 events0 affected51 at risk
EG0010 events0 affected51 at risk
EG0020 events0 affected53 at risk
EG003
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
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Sponsor has the right to submit multicenter results within 12 months after completion of the study. Thereafter, PI may publish the results of its data after submitting advance copy of the planned publication to sponsor. PI to agree to sponsor changes regarding deletion of confidential information, reasonable changes, or a delay of up to 90 days for patent purposes.
Point of Contact
Title
Organization
Phone
Extension
Email
Michelle Baron MD
Intarcia Therapeutics, Inc
510-782-7800
clinicaltrials@intarcia.com
ID
Term
D003924
Diabetes Mellitus, Type 2
Ancestor Terms
ID
Term
D003920
Diabetes Mellitus
D044882
Glucose Metabolism Disorders
D008659
Metabolic Diseases
D009750
Nutritional and Metabolic Diseases
D004700
Endocrine System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000077270
Exenatide
Ancestor Terms
ID
Term
D010455
Peptides
D000602
Amino Acids, Peptides, and Proteins
D014688
Venoms
D045424
Complex Mixtures
D014118
Toxins, Biological
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
21 subjects
FG00520 subjects
FG00620 subjects
FG00723 subjects
FG00820 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0053 subjects
FG0063 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0040 subjects
FG0051 subjects
FG0063 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG00914 subjects
FG01015 subjects
FG01111 subjects
FG01213 subjects
FG01312 subjects
FG0148 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0112 subjects
FG0123 subjects
FG0133 subjects
FG0144 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0122 subjects
FG0131 subjects
FG0141 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0143 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
FG0100 subjects
FG0111 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
hypoglycemia
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
A1C elevation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
53.7
± 8.9
0
BG0150
Between 18 and 60 years
Title
Measurements
BG00041
BG00137
BG00239
BG015117
>=60 years
Title
Measurements
BG00010
BG00114
BG00214
BG01538
24
BG01578
Male
Title
Measurements
BG00025
BG00123
BG00229
BG01577
53
BG015155
51
OG00151
OG00252
Title
Denominators
Categories
Title
Measurements
OG000-.93± 0.882
OG001-0.96± 0.724
OG002-0.75± 0.866
Ex Inj/ITCA 650 60
Stage II & Stage II Continuation
Units
Counts
Participants
OG00020
OG00121
OG00219
OG00319
OG00422
OG00520
Title
Denominators
Categories
Title
Measurements
OG000-.89± .660
OG001-1.26± .950
OG002-0.67± .908
OG003-1.36± 0.664
OG004-1.01± 0.823
OG005-1.51± 1.266
OG005
Ex Inj/ITCA 650 60
Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
Units
Counts
Participants
OG00022
OG00121
OG00223
OG00323
OG00422
OG00522
Title
Denominators
Categories
Title
Measurements
OG000-0.89± 0.660
OG001-1.26± 0.950
OG002-0.70± 0.892
OG003-1.36± 0.664
OG004-1.01± 0.823
OG005-1.51± 1.266
Ex Inj/ITCA 650 60
Stage II & Stage II Continuation
Units
Counts
Participants
OG00013
OG00114
OG00211
OG00313
OG00411
OG0058
Title
Denominators
Categories
Title
Measurements
OG000-1.00± 0.493
OG001-1.23± 0.908
OG002-0.69± 1.182
OG003-1.37± 0.837
OG004-1.45± 0.895
OG005-1.88± 1.212
OG005
Ex Inj/ITCA 650 60
Exenatide injection first 12 weeks then ITCA 650 60 mcg/day