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NCT02299050 · ClinicalTrials.gov registry record · Phase 4
Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy
A Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- Phase 4
- Development phase
- 23
- Enrollment target
NCT02299050: Completed Phase 4 study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT02299050 is a Phase 4 study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02299050, a Phase 4 study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 23 participants
- Enrollment target
Study Summary
Purpose This study will examine the effect of the addition of Cycloset upon glucose metabolism (glycemic control including post prandial glucose metabolism) in individuals with inadequately controlled (HbA1c 7.5-10.0) type 2 diabetes (T2DM) who are already on Bydureon (exenatide once weekly) or Victoza (liraglutide once daily) as part of their standard care. Both a mechanistic rationale and empirical experimental evidence implicate a beneficial interaction between bromocriptine and the incretin mimetics (GLP-1 analogs) upon postprandial hyperglycemia in insulin resistant states. One of the actions of the incretin mimetics such as the GLP-1 analogs is to stimulate postprandial beta cell insulin secretory response to plasma glucose (see drug labeling information; www.fda.gov). Thus the combination of Cycloset that is working as a post prandial insulin sensitizier with therapies that increase post prandial insulin would be expected to provide complimentary glucose lowering effects. To date, however, no such studies investigating the interactive effects of a GLP-1 analog and Bromocriptine-QR (QR=extended release) (Cycloset) have been conducted in humans. Condition - Type 2 Diabetes. Intervention - Cycloset. Phase - Phase 4 Study Type: Interventional Study Design: Treatment, Single Group Assignment, Open Label, N/A, Safety/Efficacy Study Official Title: Effect of Cycloset on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled on GLP-1 Analogue Therapy
Primary Outcome
The objective of this study is to examine the effect of the addition of Cycloset on glycemic control in inadequately controlled (HbA1c 7.5-10.0) T2DM (type 2 diabetes mellitus) patients who are already on Bydureon (exenatide once weekly) or Victoza (liraglutide ) as part of their standard care. An additional co-primary objective of the study is to examine the effect of Cycloset on postprandial glucose metabolism.
Interventions
- DRUG Cycloset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-06 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 4 |
What the finished NCT02299050 record still lists
NCT02299050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Cycloset is the first listed.
NCT02299050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02299050 about?
NCT02299050 is a clinical study titled "Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy". Purpose This study will examine the effect of the addition of Cycloset upon glucose metabolism (glycemic control including post prandial glucose metabolism) in individuals with inadequately controlled (HbA1c 7.5-10.0) type 2 diabetes (T2DM) who are already on Bydureon (exenatide once weekly) or Vict...
What is the current status of trial NCT02299050?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2014-06. Estimated completion is 2018-04-30.
What interventions are being tested in trial NCT02299050?
The interventions under investigation include: Cycloset (DRUG).
Who is sponsoring clinical trial NCT02299050?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02299050's enrollment target sits among peer trials
23 1725th of 2000 higher than 270 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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