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

• Status: Terminated
• Trial end date: 2018-01-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intarcia Therapeutics
• Treatments: Empagliflozin; Exenatide; Glimepiride; Metformin

Criteria

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.