A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes
|
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: NCT01455870 |
|
Recruitment Status :
Completed
First Posted : October 20, 2011
Last Update Posted : June 2, 2016
|
Sponsor:
Intarcia Therapeutics
Information provided by (Responsible Party):
Intarcia Therapeutics
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes | Drug: ITCA 650 60 mcg/day Drug: sitagliptin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 535 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes |
| Study Start Date : | May 2013 |
| Actual Primary Completion Date : | July 2015 |
| Actual Study Completion Date : | July 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
|
Experimental: ITCA 650 60 mcg/day
ITCA 650 is exenatide in DUROS
|
Drug: ITCA 650 60 mcg/day
exenatide in DUROS |
|
Active Comparator: sitagliptin
sitagliptin 100 mg/day
|
Drug: sitagliptin
oral sitagliptin 100 mg/day |
Primary Outcome Measures :
- Change in HbA1c between Week 52 and Day 0 [ Time Frame: 52 weeks ]
Information from the National Library of Medicine
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 |
Criteria
Inclusion Criteria:
- HbA1c between 7.5% - 10.5%
- on metformin monotherapy
- BMI between 25 & 45 kg/m2
Exclusion Criteria:
- taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
- history of pancreatitis
Information from the National Library of Medicine
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): NCT01455870
Locations
Show 54 study locations
Sponsors and Collaborators
Intarcia Therapeutics
| Responsible Party: | Intarcia Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01455870 |
| Other Study ID Numbers: |
ITCA 650-CLP-105 |
| First Posted: | October 20, 2011 Key Record Dates |
| Last Update Posted: | June 2, 2016 |
| Last Verified: | May 2016 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Phosphate Exenatide Hypoglycemic Agents Physiological Effects of Drugs |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Glucagon-Like Peptide-1 Receptor Agonists Anti-Obesity Agents |