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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 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.
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
Interventions
- DRUG Cycloset
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-06 |
| Est. Completion | 2018-04-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02299050
The ClinicalTrials.gov registry entry for NCT02299050 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cycloset is the first listed.
NCT02299050 reports 0 study locations.
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.
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