Diabetes Mellitus, Type 2
Conditions
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.
Interventions
ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
10 mg/day and 25 mg/day
1-6 mg/day
Sponsors
Intarcia Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Canada, United States
Outcome results
None listed