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

Phase 3

Terminated

Interventions: Drug: ITCA 650 20/60 mcg/day
Drug: Empagliflozin (oral)
Drug: Glimepiride (oral)

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Experimental: Group 1	ITCA 650 20/60 mcg/day	ITCA 650 20/60 mcg/day
Experimental: Group 2	Empagliflozin (oral)	Empagliflozin 10 mg/day and 25 mg/day
Experimental: Group 3	Glimepiride (oral)	Glimepiride 1-6 mg/day

Primary Outcome Measures

Name	Time	Method
Reduction in glycosylated hemoglobin A1c	Randomization to 69 weeks	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.
Reduction in weight	Randomization to 69 weeks	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.

Secondary Outcome Measures

Name	Time	Method

Locations (92): Fountain Hills Family Practice, P.C.
🇺🇸
Fountain Hills, Arizona, United States
Thomas C. Lenzmeier, M.D., P.C.
🇺🇸
Glendale, Arizona, United States
Family Practice Specialists
🇺🇸
Phoenix, Arizona, United States
Central Phoenix Medical Center
🇺🇸
Phoenix, Arizona, United States
Fiel Family and Sports Medicine
🇺🇸
Tempe, Arizona, United States
Arizona Community Physicians
🇺🇸
Tucson, Arizona, United States
Orange Grove Family Practice
🇺🇸
Tucson, Arizona, United States
Anaheim Clinical Trials
🇺🇸
Anaheim, California, United States
Radiant Research
🇺🇸
Murray, Utah, United States
Research Center of Fresno, Inc.
🇺🇸
Fresno, California, United States
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Fountain Hills Family Practice, P.C.
🇺🇸Fountain Hills, Arizona, United States