Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus

Intarcia Therapeutics

Status and phase: Completed; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Exenatide Injection; Other: Ex Inj/ITCA 650; Other: ITCA 650

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943917

ITCA 650-CLP-02

Details and patient eligibility

About

The purpose of this study is to determine safety, efficacy and tolerability of various doses of ITCA 650 in subjects with type 2 diabetes.

Enrollment: 155 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females age 18-70 years
• Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1
• On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin monotherapy;
• Fasting plasma glucose < 240 mg/dL at Screening Visit 1
• HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

Exclusion criteria

• Prior treatment with exenatide
• Treatment with any of the following antidiabetic agents within 3 months prior to Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin (injected or inhaled)
• History of type 1 diabetes and/or history of diabetic ketoacidosis
• Body mass index ≥ 40 kg/m2;
• History of organ transplantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 9 patient groups

ITCA 650 20 mcg/day

Experimental group

Treatment:

Other: ITCA 650

ITCA 650 40 mcg/day

Experimental group

Treatment:

Other: ITCA 650

Exenatide Injection

Active Comparator group

Treatment:

Drug: Exenatide Injection

ITCA 650 20/20

Experimental group

Treatment:

Other: ITCA 650

ITCA 650 20/60

Experimental group

Treatment:

Other: ITCA 650

ITCA 650 40/40

Experimental group

Treatment:

Other: ITCA 650

ITCA 650 40/80

Experimental group

Treatment:

Other: ITCA 650

Ex Inj/ITCA 650 40

Experimental group

Treatment:

Other: Ex Inj/ITCA 650

Ex Inj/ITCA 650 60

Experimental group

Treatment:

Other: Ex Inj/ITCA 650