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COMPLETED Phase 3

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

NCT01455870 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG sitagliptin
  • DRUG ITCA 650 60 mcg/day

Study Locations (20)

California

  • — Long Beach
  • — Los Angeles
  • — San Diego
  • — San Mateo
  • — Tustin
  • — Valley Village
  • — Walnut Creek

Florida

  • — Boca Raton
  • — Clearwater
  • — Coral Gables
  • — Miami
  • — North Miami Beach
  • — Pembroke Pines

Illinois

  • — Chicago
  • — Chicago

Indiana

  • — Avon
  • — Franklin

Alabama

  • — Birmingham

Arizona

  • — Chandler

Georgia

  • — Canton

Trial Details

FieldValue
Enrollment Target 535 participants
Start Date 2013-05
Est. Completion 2015-07
Phase Phase 3

Sponsor

Intarcia Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01455870

The ClinicalTrials.gov registry entry for NCT01455870 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 535 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intarcia Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions — of which sitagliptin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01455870 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01455870 about?

NCT01455870 is a clinical study titled "A Study to Evaluate ITCA 650 Compared to Sitagliptin as add-on Therapy for the Treatment of Type 2 Diabetes". Phase 3 study to compare treatment with ITCA 650 to sitagliptin when added to metformin monotherapy in patients with type 2 diabetes.

What is the current status of trial NCT01455870?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 535 participants. The study started on 2013-05. Estimated completion is 2015-07.

What conditions does trial NCT01455870 study?

This clinical trial studies the following conditions: Type 2 Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01455870?

The interventions under investigation include: sitagliptin (DRUG), ITCA 650 60 mcg/day (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01455870?

This trial is sponsored by Intarcia Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01455870 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial