Trial Outcomes & Findings for Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy (NCT NCT02299050)

NCT ID: NCT02299050

Last Updated: 2019-06-21

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

Change from baseline to four to five months

Results posted on

2019-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	Cycloset Drug - 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
Overall Study STARTED	23
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Cycloset on Glycemic Control When Added to Glucagon-like Peptide 1 (GLP-1) Analogue Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cycloset n=15 Participants Drug - 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
Age, Customized Participants age	57 years STANDARD_DEVIATION 9 • n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	4 Participants n=99 Participants
Race/Ethnicity, Customized Hispanic or Latino	15 Participants n=99 Participants
Region of Enrollment United States	15 participants n=99 Participants
Medications currently used for type 2 diabetes Liraglutide (1.2 - 1.8 mg/d)	15 Participants n=99 Participants
Medications currently used for type 2 diabetes Metformin	12 Participants n=99 Participants
Medications currently used for type 2 diabetes Low dose glargine insulin	3 Participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cycloset n=15 Participants Drug - 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
HbA1C Baseline Measurement	8.3 mmol/mol Standard Error 0.3
HbA1C Measurement at 4-5 months	7.7 mmol/mol Standard Error 0.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cycloset n=15 Participants Drug - 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
Glucose Metabolism During Mixed Meal Tolerance Test Baseline Measurement	1.1 mg/kg *min Standard Error 0.1
Glucose Metabolism During Mixed Meal Tolerance Test Measurement at 4-5 months	0.7 mg/kg *min Standard Error 0.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cycloset n=15 Participants Drug - 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
Endothelial Function, Baseline Measurement	54 mmHg Standard Error 2
Endothelial Function, Measurement at 4-5 months	51 mmHg Standard Error 2

SECONDARY outcome

Timeframe: Change from baseline to four to five months

To assess the potential beneficial effect of Cycloset on body weight composition.

Outcome measures

Outcome measures
Measure	Cycloset n=15 Participants Drug - 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
Body Composition Baseline Measurement	88.1 kg Standard Error 13.8
Body Composition Measurement at 4-5 months	87.1 kg Standard Error 13.7

SECONDARY outcome

Timeframe: Change from baseline to four to five months

To assess the potential beneficial effect of Cycloset on body fat content

Outcome measures

Outcome measures
Measure	Cycloset n=15 Participants Drug - 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
Percentage Body Fat Baseline Measurement	39.1 percentage body fat Standard Error 6.7
Percentage Body Fat Measurement at 4-5 months	39.3 percentage body fat Standard Error 7.4

SECONDARY outcome

Timeframe: Change from baseline to four to five months

To assess the potential beneficial effect of Cycloset on blood pressure.

Outcome measures

Outcome measures
Measure	Cycloset n=15 Participants Drug - 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
Blood Pressure Systolic pressure at baseline	134 mmHg Standard Error 4
Blood Pressure Systolic pressure at 4-5 months	126 mmHg Standard Error 6
Blood Pressure Diastolic pressure at baseline	78 mmHg Standard Error 3
Blood Pressure Diastolic pressure at 4-5 months	73 mmHg Standard Error 4

SECONDARY outcome

Timeframe: Change from baseline to four to five months

To assess the potential beneficial effect of Cycloset on change in mean arterial blood pressure

Outcome measures

Outcome measures
Measure	Cycloset n=15 Participants Drug - 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
Mean Arterial Blood Pressure Baseline Measurement	97 mmHg Standard Error 5
Mean Arterial Blood Pressure Measurement at 4-5 months	90 mmHg Standard Error 4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cycloset n=15 Participants Drug - 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
Arterial Stiffness (AS) Baseline Measurement	19.8 au (arbitrary units) Standard Error 4.1
Arterial Stiffness (AS) Measurement at 4-5 months	16.2 au (arbitrary units) Standard Error 3.7

Adverse Events

Cycloset

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cycloset n=15 participants at risk Drug - 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
Cardiac disorders Orthostatic Hypotension	13.3% 2/15 • Number of events 2 • Adverse events were captured from baseline to between 4 to 5 months
Nervous system disorders Light-headedness	13.3% 2/15 • Number of events 2 • Adverse events were captured from baseline to between 4 to 5 months
Gastrointestinal disorders Nausea	13.3% 2/15 • Number of events 2 • Adverse events were captured from baseline to between 4 to 5 months
Gastrointestinal disorders Vomiting	13.3% 2/15 • Number of events 2 • Adverse events were captured from baseline to between 4 to 5 months

Additional Information

Mariam Alatrach

University of Texas Health San Antonio

Phone: 210-358-7220

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place