HbA1C
| Group | Value (mmol/mol) | Spread |
|---|---|---|
| Cycloset | 8.3 | 0.3 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataThis trial does not test a peptide that PepBank tracks.
United States
1 trial · 1 completed · 1 with posted results
Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy
NCT02299050Jun 2014 to 30 Apr 2018
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Other
Cycloset
Drug - Cycloset Cycloset 2.4 -3.2 mg/day Other Names: Bromocriptine Mesylate Quick Release
Outcomes the sponsor listed as primary.
HbA1C
Time frame · Change from baseline to four to five months
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.
Glucose Metabolism During Mixed Meal Tolerance Test
Time frame · Change from baseline to four to five months
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 patients who are already on Bydureon (exenatide once weekly) or Victoza (liraglutide ) as part of their standard care.
Endothelial Function,
Time frame · Change from baseline to four to five months
To assess the potential beneficial effect of Cycloset on endothelial function. This is measured by using pulse pressure.
Body Composition
Time frame · Change from baseline to four to five months
To assess the potential beneficial effect of Cycloset on body weight composition.
Percentage Body Fat
Time frame · Change from baseline to four to five months
To assess the potential beneficial effect of Cycloset on body fat content
Blood Pressure
Time frame · Change from baseline to four to five months
To assess the potential beneficial effect of Cycloset on blood pressure.
Mean Arterial Blood Pressure
Time frame · Change from baseline to four to five months
To assess the potential beneficial effect of Cycloset on change in mean arterial blood pressure
Arterial Stiffness (AS)
Time frame · Change from baseline to four to five months
To assess the potential beneficial effect of Cycloset on arterial stiffness. Arterial stiffness is calculated by the measurement of pulse pressure, where Pulse pressure = SBP - DBP (Where SBP is systolic blood pressure and DBP is diastolic blood pressure) The calculated value is used as a predictor of cardiovascular disease. Higher values indicate that cardiovascular disease is more likely.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mmol/mol) | Spread |
|---|---|---|
| Cycloset | 8.3 | 0.3 |
| Group | Value (mg/kg *min) | Spread |
|---|---|---|
| Cycloset | 1.1 | 0.1 |
| Group | Value (mmHg) | Spread |
|---|---|---|
| Cycloset | 54 | 2 |
| Group | Value (kg) | Spread |
|---|---|---|
| Cycloset | 88.1 | 13.8 |
| Group | Value (percentage body fat) | Spread |
|---|---|---|
| Cycloset | 39.1 | 6.7 |
| Group | Value (mmHg) | Spread |
|---|---|---|
| Cycloset | 134 | 4 |
| Group | Value (mmHg) | Spread |
|---|---|---|
| Cycloset | 97 | 5 |
| Group | Value (au (arbitrary units)) | Spread |
|---|---|---|
| Cycloset | 19.8 | 4.1 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| CyclosetDrug - Cycloset Cycloset 2.4 -3.2 mg/day Other Names: Bromocriptine Mesylate Quick Release Cycloset: Bromocriptine QR 0.8 mg tablet 0.8 mg/day with dose increased to a maximum of 3.2 mg/day or as tolerated to a minimum of 2.4 mg/day Other names: Cycloset, B-QR | 2 / 15 | 0 / 15 | 2 / 15 |
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Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
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