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evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mcg./day | Experimental | ITCA 650 (exenatide in DUROS) |
|
| 20 mcg/day | Experimental | ITCA 650 (exenatide in DUROS) |
|
| 40 mcg/day | Experimental | ITCA 650 (exenatide in DUROS) |
|
| 80 mcg/day | Experimental | ITCA 650 (exenatide in DUROS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITCA 650 (exenatide in DUROS) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Study Drug-Related Adverse Events | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus | Change in HbA1c from baseline | 4 weeks |
| Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Gardens | Florida | 33169 | United States | |||
| Medpace Clinical Pharmacology Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23578605 | Derived | Henry RR, Logan D, Alessi T, Baron MA. A randomized, open-label, multicenter, 4-week study to evaluate the tolerability and pharmacokinetics of ITCA 650 in patients with type 2 diabetes. Clin Ther. 2013 May;35(5):634-645.e1. doi: 10.1016/j.clinthera.2013.03.011. Epub 2013 Apr 8. |
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Initiated February 2009 completed 15 May 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 Mcg/Day | ITCA 650 (exenatide in DUROS) |
| FG001 | 20 Mcg/Day | ITCA 650 (exenatide in DUROS) |
| FG002 | 40 Mcg/Day | ITCA 650 (exenatide in DUROS) |
| FG003 | 80 Mcg/Day | ITCA 650 (exenatide in DUROS) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 Mcg/Day | ITCA 650 (exenatide in DUROS) |
| BG001 | 20 Mcg/Day | ITCA 650 (exenatide in DUROS) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Number of Subjects With Study Drug-Related Adverse Events | Number of subjects reporting study drug-related adverse events | Posted | Number | participants | 4 weeks |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 10 Mcg/Day | ITCA 650 (exenatide in DUROS) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eye swelling | Eye disorders | MedDRA (11.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Braon | Intarcia | 510-782-7800 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| 4 weeks |
| Change in Weight From Baseline to 4 Weeks | 4 weeks |
| Cincinnati |
| Ohio |
| 45212 |
| United States |
| dGd Research | San Antonio | Texas | 78229 | United States |
| BG002 |
| 40 Mcg/Day |
ITCA 650 (exenatide in DUROS) |
| BG003 | 80 Mcg/Day | ITCA 650 (exenatide in DUROS) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 80 Mcg/Day |
ITCA 650 (exenatide in DUROS) |
|
|
| Secondary | To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus | Change in HbA1c from baseline | Posted | Mean | Standard Deviation | percentage | 4 weeks |
|
|
|
| Secondary | Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline | Posted | Mean | Standard Deviation | mg/dL | 4 weeks |
|
|
|
| Secondary | Change in Weight From Baseline to 4 Weeks | Posted | Mean | Standard Deviation | kg | 4 weeks |
|
|
|
| 0 |
| 12 |
| 12 |
| 12 |
| EG001 | 20 Mcg/Day | ITCA 650 (exenatide in DUROS) | 0 | 11 | 11 | 11 |
| EG002 | 40 Mcg/Day | ITCA 650 (exenatide in DUROS) | 0 | 10 | 9 | 10 |
| EG003 | 80 Mcg/Day | ITCA 650 (exenatide in DUROS) | 0 | 11 | 11 | 11 |
| photophobia | Eye disorders | MedDRA (11.0) |
|
| nausea | Gastrointestinal disorders | MedDRA (11.0) |
|
| vomiting | Gastrointestinal disorders | MedDRA (11.0) |
|
| dyspepsia | General disorders | MedDRA (11.0) |
|
| diarrhea | Gastrointestinal disorders | MedDRA (11.0) |
|
| eructation | Gastrointestinal disorders | MedDRA (11.0) |
|
| abdominal disomfort | Gastrointestinal disorders | MedDRA (11.0) |
|
| GERD | Gastrointestinal disorders | MedDRA (11.0) |
|
| early satiety | General disorders | MedDRA (11.0) |
|
| chills | General disorders | MedDRA (11.0) |
|
| feeling hot | General disorders | MedDRA (11.0) |
|
| incision site erythema | Injury, poisoning and procedural complications | MedDRA (11.0) |
|
| incision site complication | Injury, poisoning and procedural complications | MedDRA (11.0) |
|
| incision site hemmorhage | Injury, poisoning and procedural complications | MedDRA (11.0) |
|
| incision site pain | Injury, poisoning and procedural complications | MedDRA (11.0) |
|
| incision site blister | Injury, poisoning and procedural complications | MedDRA (11.0) |
|
| incision site edema | Injury, poisoning and procedural complications | MedDRA (11.0) |
|
| decreased appetite | Metabolism and nutrition disorders | MedDRA (11.0) |
|
| hyperlipasaemia | Metabolism and nutrition disorders | MedDRA (11.0) |
|
| hyperamylasemia | Metabolism and nutrition disorders | MedDRA (11.0) |
|
| hypoglycemia | Metabolism and nutrition disorders | MedDRA (11.0) |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) |
|
| headache | Nervous system disorders | MedDRA (11.0) |
|
| dizziness | Nervous system disorders | MedDRA (11.0) |
|
| paresthesia | Nervous system disorders | MedDRA (11.0) |
|
| dizziness extertional | Nervous system disorders | MedDRA (11.0) |
|
| lethargy | Nervous system disorders | MedDRA (11.0) |
|
| syncope vasovagal | Nervous system disorders | MedDRA (11.0) |
|
| anxiety | Psychiatric disorders | MedDRA (11.0) |
|
| libido decreased | Psychiatric disorders | MedDRA (11.0) |
|
| vulvovaginal dryness | Reproductive system and breast disorders | MedDRA (11.0) |
|
| hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.0) |
|
| orthostatic hypotension | Vascular disorders | MedDRA (11.0) |
|
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| D004700 | Endocrine System Diseases |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |