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

Intarcia Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03060980

ITCA 650-CLP-203

Details and patient eligibility

About

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.

Enrollment: 245 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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245 participants in 3 patient groups

Experimental: Group 1

Experimental group

Description:

ITCA 650 20/60 mcg/day

Treatment:

Drug: ITCA 650 20/60 mcg/day

Experimental: Group 2

Experimental group

Description:

Empagliflozin 10 mg/day and 25 mg/day

Treatment:

Drug: Empagliflozin (oral)

Experimental: Group 3

Experimental group

Description:

Glimepiride 1-6 mg/day

Treatment:

Drug: Glimepiride (oral)