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

NCT01455870 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 535

Last updated 2016-06-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

ITCA 650 60 mcg/day

exenatide in DUROS

DRUG

sitagliptin

oral sitagliptin 100 mg/day

Sponsors & Collaborators

  • Intarcia Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Croatia
  • Denmark
  • Germany
  • Latvia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01455870 on ClinicalTrials.gov