A Study to Evaluate ITCA 650 Compared to Glimepiride as Add on Therapy for the Treatment of Type 2 Diabetes

Intarcia Therapeutics

Status and phase: Withdrawn; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: ITCA 650; Drug: glimepiride

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455922

ITCA 650-CLP-112

Details and patient eligibility

About

Phase 3 study to examine treatment with ITCA 650 compared to glimepiride when added to metformin monotherapy in reducing HbA1c in patients with type 2 diabetes.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HbA1c between 7.5% - 10.5%
• on metformin monotherapy
• BMI between 25 & 45 kg/m2

Exclusion criteria

• On thiazolidinedione, sulfonylurea, DPP-4, alpha glucosidase inhibitor, meglitinides or insulin within last 3 months
• history of pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups

ITCA 650 60 mcg/day

Experimental group

Treatment:

Drug: ITCA 650

glimepiride

Active Comparator group

Treatment:

Drug: glimepiride