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NCT02638805 · ClinicalTrials.gov registry record · Phase 3

Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide

A Phase 3 study, sponsored by Intarcia Therapeutics.

Completed
Registry status
Phase 3
Development phase
136
Enrollment target

NCT02638805: Completed Phase 3 study, sponsored by Intarcia Therapeutics.

NCT02638805 is a Phase 3 study that has completed, run by Intarcia Therapeutics. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02638805, a Phase 3 study, has completed, sponsored by Intarcia Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
136 participants
Enrollment target

Study Summary

A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.

Primary Outcome

Number (percentage) and severity of treatment-emergent AEs (TEAEs) of nausea and/or vomiting over the 26-week treatment period; treatment discontinuation for nausea and/or vomiting; and pattern of nausea and/or vomiting over time.

Interventions

  • DRUG Metformin
  • DRUG Liraglutide
  • DRUG ITCA 650 Osmotic Mini Pump 20/60 mcg/day
  • DRUG ITCA 650 Osmotic Mini Pump 60 mcg/day

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2015-12
Est. Completion 2017-10
Phase Phase 3
Intarcia Therapeutics

16 total trials

What the finished NCT02638805 record still lists

NCT02638805 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 4 interventions - of which Metformin is the first listed.

NCT02638805 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02638805 about?

NCT02638805 is a clinical study titled "Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide". A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.

What is the current status of trial NCT02638805?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2015-12. Estimated completion is 2017-10.

What interventions are being tested in trial NCT02638805?

The interventions under investigation include: Metformin (DRUG), Liraglutide (DRUG), ITCA 650 Osmotic Mini Pump 20/60 mcg/day (DRUG), ITCA 650 Osmotic Mini Pump 60 mcg/day (DRUG).

Who is sponsoring clinical trial NCT02638805?

This trial is sponsored by Intarcia Therapeutics, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02638805's enrollment target sits among peer trials

136 1580th of 2000 higher than 419 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02638805, the US trial registry maintained by the National Library of Medicine. NCT02638805 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.