13 completed, 5 terminated, 3 withdrawn. 13 Phase 3, 6 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 5, Terminated 5, Withdrawn 3 |
| Phase 1 | 6 | Completed 6 |
| Phase 2 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin ITCA 650 20/60 mcg/day, Empagliflozin (oral), Glimepiride (oral) - Diabetes Mellitus, Type 2 | Phase 3 | Terminated | Intarcia Therapeutics | 245 | 2017-03-03 | 2019-03-07 |
| Study of the Effects of Intravenous Exenatide on Cardiac Repolarization Exenatide, Placebo, Moxifloxacin - Healthy Adult Male and Female Volunteers | Phase 1 | Completed | Intarcia Therapeutics | 82 | 2016-01-01 | 2017-01-27 |
| Study of the Effect of ITCA 650 on the PK/PD of Oral Contraceptive in Healthy Female Subjects ITCA 650 20/60 mcg/day, ITCA placebo, ITCA placebo, ITCA 650 20/60 mcg/day - Healthy Adult Premenopausal Female Volunteers | Phase 1 | Completed | Intarcia Therapeutics | 28 | 2015-12-01 | 2016-03-22 |
| Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide ITCA 650 Osmotic Mini Pump 20/60 mcg/day, ITCA 650 Osmotic Mini Pump 60 mcg/day, Metformin - Diabetes Mellitus, Type 2 | Phase 3 | Completed | Intarcia Therapeutics | 136 | 2015-12-01 | 2018-11-05 |
| Study of the Effects of ITCA 650 on Gastric Emptying and Interaction of ITCA 650 on 4 Commonly Studied Drugs ITCA 650 20/60 mcg/day, Acetaminophen, Atorvastatin - Healthy | Phase 1 | Completed | Intarcia Therapeutics | 33 | 2015-12-01 | 2017-01-27 |
| Study to Evaluate Pharmacokinetics of ITCA 650 in Subjects With Renal Impairment Compared to Normal Subjects ITCA 650 (Exenatide in osmotic mini pump) - Renal Insufficiency | Phase 1 | Completed | Intarcia Therapeutics | 38 | 2014-11-01 | 2016-06-03 |
| A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c ITCA 650 (exenatide in DUROS) - Type 2 Diabetes | Phase 3 | Terminated | Intarcia Therapeutics | 100 | 2013-05-01 | 2019-03-07 |
| A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes ITCA 650 60 mcg/day, sitagliptin - Type 2 Diabetes | Phase 3 | Completed | Intarcia Therapeutics | 535 | 2013-05-01 | 2016-06-02 |
| A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes ITCA 650, ITCA placebo - Type 2 Diabetes | Phase 3 | Completed | Intarcia Therapeutics | 460 | 2013-03-01 | 2015-08-18 |
| A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650 ITCA 650, ITCA placebo - Type 2 Diabetes | Phase 3 | Completed | Intarcia Therapeutics | 4156 | 2013-03-01 | 2017-01-27 |
| A Study to Evaluate ITCA 650 Compared to Glimepiride for the Treatment of Type 2 Diabetes ITCA 650 60 mcg/day, glimepiride - Type 2 Diabetes | Phase 3 | Withdrawn | Intarcia Therapeutics | 2013-02-01 | 2012-12-25 | |
| A Study to Evaluate ITCA 650 Compared to Sitagliptin for the Treatment of Type 2 Diabetes ITCA 650 60 mcg/day, sitagliptin - Type 2 Diabetes | Phase 3 | Withdrawn | Intarcia Therapeutics | 2013-02-01 | 2012-12-25 | |
| A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes ITCA 650, glimepiride - Type 2 Diabetes | Phase 3 | Withdrawn | Intarcia Therapeutics | 2013-02-01 | 2012-12-25 | |
| Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus ITCA 650, Exenatide Injection, Ex Inj/ITCA 650 - Type 2 Diabetes | Phase 2 | Completed | Intarcia Therapeutics | 155 | 2009-08-01 | 2015-04-13 |
| Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes ITCA 650 (exenatide in DUROS) - Type 2 Diabetes | Phase 1 | Completed | Intarcia Therapeutics | 44 | 2009-02-01 | 2013-05-17 |
| Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment Omega DUROS device - Chronic Hepatitis C | Phase 1 | Completed | Intarcia Therapeutics | 60 | 2007-08-01 | 2011-06-08 |
| Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer Atamestane, toremifene, letrozole - Breast Neoplasms, Neoplasms, Hormone-Dependent | Phase 3 | Terminated | Intarcia Therapeutics | 200 | 2005-11-01 | 2007-09-10 |
| The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer Atamestane, Toremifene, Letrozole - Breast Neoplasms, Neoplasms, Hormone-Dependent | Phase 3 | Terminated | Intarcia Therapeutics | 842 | 2004-12-01 | 2007-08-23 |
| Omega Interferon Alone or in Combination With Ribavirin in Subjects With Hepatitis C omega interferon, Ribavirin - Hepatitis C | Phase 2 | Completed | Intarcia Therapeutics | 90 | 2004-11-01 | 2007-08-23 |
| Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer atamestane, toremifene, letrozole - Breast Neoplasms, Neoplasms, Hormone-dependent | Phase 3 | Completed | Intarcia Therapeutics | 865 | 2002-06-01 | 2015-07-31 |
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Diabetes Mellitus, Type 2 (11) · Breast Neoplasms (4) · Carcinoma, Ductal, Breast (3) · Carcinoma, Lobular (3) · Neoplasms, Hormone-Dependent (3) · Hepatitis C (2) · Hepatitis C, Chronic (1) · Recurrence (1) · Renal Insufficiency (1)
Exenatide (14) · Toremifene (4) · atamestane (4) · Letrozole (3) · glimepiride (3) · Aromatase Inhibitors (2) · Estrogen Receptor Modulators (2) · Sitagliptin Phosphate (2) · Acetaminophen (1) · Atorvastatin (1) · Digoxin (1) · Liraglutide (1) · Lisinopril (1) · Metformin (1) · Moxifloxacin (1)
United States (19) · Russia (4) · Canada (3) · Germany (3) · Ukraine (3) · Bulgaria (2) · Denmark (2) · Croatia (1) · Finland (1) · Latvia (1) · Netherlands (1) · Poland (1) · Puerto Rico (1) · Romania (1) · Slovakia (1)
Peter Langecker, MD, PhD (2) · Edith Perez, MD (1) · Paul Goss, M.D. (1)
PMID 23578605, PMID 23645886, PMID 29242349, PMID 29301824, PMID 29693361, PMID 34873344