Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin

Study Overview
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Brief Summary
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A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.

Official Title
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A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: ITCA 650 20/60 mcg/day
* Drug: Empagliflozin (oral)
* Drug: Glimepiride (oral)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of T2D 3 months prior to the Screening Visit. Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit. Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%. 5. 6. On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day). Exclusion Criteria: History of type 1 diabetes. Prior participation in a clinical study involving ITCA 650. Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening. History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke. History or evidence of acute or chronic pancreatitis. History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2. Treatment of medications that affect GI motility. History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients. Women that are pregnant, lactating, or planning to become pregnant. Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Experimental: Group 1<br>ITCA 650 20/60 mcg/day | Drug: ITCA 650 20/60 mcg/day<br>* ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day<br>|
| Experimental: Experimental: Group 2<br>Empagliflozin 10 mg/day and 25 mg/day | Drug: Empagliflozin (oral)<br>* 10 mg/day and 25 mg/day<br>|
| Experimental: Experimental: Group 3<br>Glimepiride 1-6 mg/day | Drug: Glimepiride (oral)<br>* 1-6 mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in glycosylated hemoglobin A1c | To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up. | Randomization to 69 weeks | 
| Reduction in weight | To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up. | Randomization to 69 weeks |