A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes

Intarcia Therapeutics535 enrolled

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

Enrollment

535

Conditions

Type 2 Diabetes

Interventions

ITCA 650 60 mcg/dayDRUG

exenatide in DUROS

sitagliptinDRUG

oral sitagliptin 100 mg/day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HbA1c between 7.5% - 10.5% * 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 (54)

Outcomes

Primary Outcomes

Change in HbA1c between Week 52 and Day 0

Time frame: 52 weeks

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

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Chandler, Arizona, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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San Diego, California, United States

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San Mateo, California, United States

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Tustin, California, United States

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Valley Village, California, United States

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Walnut Creek, California, United States

Unnamed facility

Boca Raton, Florida, United States

...and 44 more locations