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NCT03060980 · ClinicalTrials.gov registry record · Phase 3
Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin
A Phase 3 study, sponsored by Intarcia Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 245
- Enrollment target
NCT03060980: Clinical Trial Phase 3 study, sponsored by Intarcia Therapeutics.
NCT03060980 is a Phase 3 study that was terminated before completion, run by Intarcia Therapeutics. The registered enrollment target is 245 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03060980, a Phase 3 study, was terminated before completion, sponsored by Intarcia Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 245 participants
- Enrollment target
Study Summary
A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
Primary Outcome
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Interventions
- DRUG Empagliflozin (oral)
- DRUG ITCA 650 20/60 mcg/day
- DRUG Glimepiride (oral)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2017-03-03 |
| Est. Completion | 2018-01-26 |
| Phase | Phase 3 |
Why NCT03060980 stopped before completion
NCT03060980 is an interventional study that assigns participants to a tested intervention. The registered 245 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 (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Empagliflozin (oral) is the first listed.
NCT03060980 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03060980 about?
NCT03060980 is a clinical study titled "Comparison of Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and Glimepiride as add-on Metformin". A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
What is the current status of trial NCT03060980?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 245 participants. The study started on 2017-03-03. Estimated completion is 2018-01-26.
What interventions are being tested in trial NCT03060980?
The interventions under investigation include: Empagliflozin (oral) (DRUG), ITCA 650 20/60 mcg/day (DRUG), Glimepiride (oral) (DRUG).
Who is sponsoring clinical trial NCT03060980?
This trial is sponsored by Intarcia Therapeutics, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03060980's enrollment target sits among peer trials
245 1267th of 2000 higher than 732 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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