Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.

Official Title
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Phase 2 Study of ITCA 650 in Subjects With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: ITCA 650
* Drug: Exenatide Injection
* Other: Ex Inj/ITCA 650


Participation Criteria
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Eligibility Criteria
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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 Body mass index ≥ 40 kg/m2; History of organ transplantation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITCA 650 20 mcg/day<br> | Other: ITCA 650<br>* ITCA 650 (continuous delivery of exenatide in DUROS)<br>|
| Experimental: ITCA 650 40 mcg/day<br> | Other: ITCA 650<br>* ITCA 650 (continuous delivery of exenatide in DUROS)<br>|
| Active Comparator: Exenatide Injection<br> | Drug: Exenatide Injection<br>* twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks<br>* Other names: Byetta;|
| Experimental: ITCA 650 20/20<br> | Other: ITCA 650<br>* ITCA 650 (continuous delivery of exenatide in DUROS)<br>|
| Experimental: ITCA 650 20/60<br> | Other: ITCA 650<br>* ITCA 650 (continuous delivery of exenatide in DUROS)<br>|
| Experimental: ITCA 650 40/40<br> | Other: ITCA 650<br>* ITCA 650 (continuous delivery of exenatide in DUROS)<br>|
| Experimental: ITCA 650 40/80<br> | Other: ITCA 650<br>* ITCA 650 (continuous delivery of exenatide in DUROS)<br>|
| Experimental: Ex Inj/ITCA 650 40<br> | Other: Ex Inj/ITCA 650<br>* twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650<br>* Other names: Byetta;|
| Experimental: Ex Inj/ITCA 650 60<br> | Other: Ex Inj/ITCA 650<br>* twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650<br>* Other names: Byetta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |