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

A Phase 3, Randomized, Active Comparator, Double-Blind, Multi-Center Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Sitagliptin as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01455870

Enrollment

535

Registered

2011-10-20

Start date

2013-05-31

Completion date

2015-07-31

Last updated

2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

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

Interventions

DRUGITCA 650 60 mcg/day

exenatide in DUROS

DRUGsitagliptin

oral sitagliptin 100 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c between Week 52 and Day 0	52 weeks

Countries

Croatia, Denmark, Germany, Latvia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026