A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes

Intarcia Therapeutics

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: ITCA 650; Other: ITCA placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01455857

ITCA 650-CLP-103

Details and patient eligibility

About

Phase 3 study to examine whether treatment with ITCA-650 60 mcg/day or 40 mcg/day is superior to placebo when added to current therapy in reducing HbA1c in patients with type 2 diabetes.

Enrollment: 460 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HbA1c between 7.5% - 10%
• On diet & exercise, metformin (MET), sulfonylurea (SU) or thiazolidinedione (TZD) alone or in combination or combined (SU + TZD) or in combination with Met + SU, Met + TZD, Met + TZD + SU
• BMI between 25 & 45 kg/m2

Exclusion criteria

• taking DPP-4 inhibitors, exenatide, liraglutide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
• history of pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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460 participants in 3 patient groups, including a placebo group

ITCA 650 40 mcg/day

Experimental group

Treatment:

Drug: ITCA 650

ITCA 650 60 mcg/day

Experimental group

Treatment:

Drug: ITCA 650

ITCA placebo

Placebo Comparator group

Treatment:

Other: ITCA placebo