A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01785771 |
Recruitment Status :
Terminated
(Decision by Sponsor)
First Posted : February 7, 2013
Last Update Posted : March 7, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 2 Diabetes | Drug: ITCA 650 (exenatide in DUROS) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label Multi-Center Sub-Study to Evaluate the Efficacy, Safety and Tolerability of ITCA 650 in Patients With Type 2 Diabetes With High Baseline HbA1c |
Study Start Date : | May 2013 |
Actual Primary Completion Date : | January 2018 |
Actual Study Completion Date : | January 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: ITCA 650 |
Drug: ITCA 650 (exenatide in DUROS) |
- Change in HbA1c between Week 39 and Day 0 [ Time Frame: 39 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men or women age 18 to 80 years with type 2 diabetes
- On stable treatment regimen of diet and exercise alone or in combination with a stable & optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
- HbA1c >10.0% and ≤12.0%
Exclusion Criteria:
- Prior treatment with any GLP-1 receptor agonist
- History of hypersensitivity to exenatide or liraglutide
- FPG >300 mg/dL
- History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
- Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785771
Responsible Party: | Intarcia Therapeutics |
ClinicalTrials.gov Identifier: | NCT01785771 |
Other Study ID Numbers: |
ITCA 650-CLP-103-Sub-Study |
First Posted: | February 7, 2013 Key Record Dates |
Last Update Posted: | March 7, 2019 |
Last Verified: | March 2019 |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide Glucagon-Like Peptide-1 Receptor Agonists |
Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |