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

Intarcia Therapeutics

Overview

Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Type 2 Diabetes

Interventions

ITCA 650 60 mcg/dayDRUG

exenatide in DUROS

sitagliptinDRUG

sitagliptin oral 100 mg/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HbA1c between 7.5%-10% * on metformin monotherapy * BMI between 25 \& 45 kg/m2 Exclusion Criteria: * taking thiazolidinedione, sulfonylurea, DPP-4, exenatide, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months * history of pancreatitis

Locations (1)

Intarcia Therapeutics, Inc

Hayward, California, United States

Outcomes

Primary Outcomes

Change in HbA1c

39-week treatment period followed by 65-week extension period

Time frame: 39 weeks

Data from ClinicalTrials.gov

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