Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes

Intarcia Therapeutics

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: ITCA 650 (exenatide in DUROS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01798264

ITCA 650-CLP-01

Details and patient eligibility

About

evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.

Enrollment: 44 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 2 diabetes >6 months
• stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%

Exclusion criteria

• prior treatment with exenatide
• history of pancreatitis
• history of medullary thyroid cancer or multiple endocrine neoplasia 2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

10 mcg./day

Experimental group

Description:

ITCA 650 (exenatide in DUROS)

Treatment:

Drug: ITCA 650 (exenatide in DUROS)

20 mcg/day

Experimental group

Description:

ITCA 650 (exenatide in DUROS)

Treatment:

Drug: ITCA 650 (exenatide in DUROS)

40 mcg/day

Experimental group

Description:

ITCA 650 (exenatide in DUROS)

Treatment:

Drug: ITCA 650 (exenatide in DUROS)

80 mcg/day

Experimental group

Description:

ITCA 650 (exenatide in DUROS)

Treatment:

Drug: ITCA 650 (exenatide in DUROS)