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CompletedNCT02299050Updated Jun 21, 2019Results posted

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

A Phase 4 interventional study of Cycloset in Type 2 Diabetes, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 30 Years to 69 Years. Per ClinicalTrials.gov, last updated 2019-06-21.

Sponsored by The University of Texas Health Science Center at San Antonio · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
30 Years to 69 Years
Sex
All
01

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

Read the detailed description

This is a single-site, prospective, cohort study that will assess the effect of Cycloset as add-on therapy in adult subjects with T2DM that is inadequately controlled (HbA1c 7.5% to 10.0%) on GLP-1 analog therapy with either exenatide (Bydureon) once weekly or liraglutide (Victoza) once daily.

Entry criteria will be checked at the screening visit. All qualified subjects will undergo baseline studies including non-invasive hemodynamic testing for assessment of aortic stiffness and pulse wave velocity, assessment of body weight composition by dual-energy X-ray absorptiometry (DXA), assessment of endothelial function using the Endo-PAT device, measurement of cytokines and inflammatory biomarkers in the peripheral blood and urine, assessment of oxidative stress and inflammatory markers in white blood cells isolated from a peripheral whole blood sample, a 5-hour mixed meal tolerance test (MMT) for assessment of postprandial glucose metabolism and 24-hour ambulatory BP monitoring.

Following completion of all the baseline studies as above, subjects will be started on Cycloset, 0.8 mg/day in addition to their stable dose of Bydureon (exenatide) (2mg/week) or Victoza (liraglutide) (1.2-1.8 mg/day), and the dose will be increased by 0.8 mg/day every week to a maximum of 3.2 mg/day, or as tolerated to a minimum of 2.4 mg/day.

Subjects will return at months 1, 2, 3, and 4 for interim medical history, body weight, HbA1c, and FPG (Fasting plasma glucose). Postural blood pressure measurements will be obtained with the subject lying down and then after standing for 5 minutes at each of the visits. At month 4, all of the baseline studies detailed above will be repeated.

All tests will be performed in the Clinical Research Center at the Texas Diabetes Institute/University of Texas Health Science Center, San Antonio.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Type 2 Diabetes
  • T2DM
  • Cycloset
  • Glycemic Control
  • GLP-1
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 23 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Type 2 diabetes male or female subjects between the ages of 30 and 70 years of age, inclusive, at Screening
  • BMI = 24-40 kg/m2
  • HbA1c = 7.5-10.0%
  • Stable body weight (±3-4lbs) over the preceding 3 months
  • Subjects currently receiving a stable dose of exenatide (2mg/week) or liraglutide (1.2-1.8 mg/day) for at least 90 days prior to determination of baseline HbA1C and eligibility for enrollment in the study protocol.
  • Subjects with a daytime feeding/night time sleeping schedule
  • Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
  • Women must be of non-childbearing potential as defined by one of the following:
  • Women >45 and \< 60 years of age at Screening, who have been amenorrheic for at least 2 years
  • Women who have had a documented hysterectomy and/or bilateral oophorectomy
  • Women > 60 years of age
  • Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose): Oral contraceptive, Injectable progesterone, subdermal implant, spermicidal foam/gel/film/cream/suppository, diaphragm with spermicide, copper or hormonal containing IUD (intrauterine device), sterile male partner vasectomized > 6 month pre-dosing
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
  • Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.

Exclusion criteria

Exclusion Criteria:

  • Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease.
  • No history of T2DM
  • BMI of less 24 and greater 40 kg/m2
  • Unstable body weight (change of greater than ±3-4lbs over the preceding 3 months
  • Subjects not currently receiving exenatide or liraglutide
  • Subjects participating in an excessively heavy exercise program
  • Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule
  • Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neuro synaptic function are excluded.
  • Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
  • Pregnant subjects or subjects unwilling to use birth control during their study enrollment
  • Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening 12. Subjects that are allergic to bromocriptine or any of the other ingredients in Cycloset, or take ergot medicines, breastfeeding or have history of syncope or Type 1 diabetes mellitus
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results that, in the judgment of the investigator, would make the subject inappropriate for entry into this study subjects of reproductive potential
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Other
    Cycloset

    Drug - Cycloset Cycloset 2.4 -3.2 mg/day Other Names: Bromocriptine Mesylate Quick Release

    Drug: Cycloset

Interventions

  • DrugCycloset

    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

    Also known as: Bromocriptine Mesylate Quick Release

06

What researchers measure

Primary outcomes

  1. HbA1C

    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.

    Time frame: Change from baseline to four to five months

  2. Glucose Metabolism During Mixed Meal Tolerance Test

    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.

    Time frame: Change from baseline to four to five months

Secondary outcomes

  1. Endothelial Function,

    To assess the potential beneficial effect of Cycloset on endothelial function. This is measured by using pulse pressure.

    Time frame: Change from baseline to four to five months

  2. Body Composition

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

    Time frame: Change from baseline to four to five months

  3. Percentage Body Fat

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

    Time frame: Change from baseline to four to five months

  4. Blood Pressure

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

    Time frame: Change from baseline to four to five months

  5. Mean Arterial Blood Pressure

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

    Time frame: Change from baseline to four to five months

  6. Arterial Stiffness (AS)

    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.

    Time frame: Change from baseline to four to five months

07

Results

Posted Jun 21, 2019

Participant flow

Participant flow — Overall Study
MilestoneCycloset
Started23
Completed15
Not completed8

Outcome measures

PrimaryHbA1C

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.

Time frame:
Change from baseline to four to five months
Reported as:
Mean · mmol/mol
HbA1C
mmol/molCycloset
Baseline Measurement8.3 ± 0.3
Measurement at 4-5 months7.7 ± 0.2
PrimaryGlucose Metabolism During Mixed Meal Tolerance Test

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.

Time frame:
Change from baseline to four to five months
Reported as:
Mean · mg/kg *min
Glucose Metabolism During Mixed Meal Tolerance Test
mg/kg *minCycloset
Baseline Measurement1.1 ± 0.1
Measurement at 4-5 months0.7 ± 0.1
SecondaryEndothelial Function,

To assess the potential beneficial effect of Cycloset on endothelial function. This is measured by using pulse pressure.

Time frame:
Change from baseline to four to five months
Reported as:
Mean · mmHg
Endothelial Function,
mmHgCycloset
Baseline Measurement54 ± 2
Measurement at 4-5 months51 ± 2
SecondaryBody Composition

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

Time frame:
Change from baseline to four to five months
Reported as:
Mean · kg
Body Composition
kgCycloset
Baseline Measurement88.1 ± 13.8
Measurement at 4-5 months87.1 ± 13.7
SecondaryPercentage Body Fat

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

Time frame:
Change from baseline to four to five months
Reported as:
Mean · percentage body fat
Percentage Body Fat
percentage body fatCycloset
Baseline Measurement39.1 ± 6.7
Measurement at 4-5 months39.3 ± 7.4
SecondaryBlood Pressure

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

Time frame:
Change from baseline to four to five months
Reported as:
Mean · mmHg
Blood Pressure
mmHgCycloset
Systolic pressure at baseline134 ± 4
Systolic pressure at 4-5 months126 ± 6
Diastolic pressure at baseline78 ± 3
Diastolic pressure at 4-5 months73 ± 4
SecondaryMean Arterial Blood Pressure

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

Time frame:
Change from baseline to four to five months
Reported as:
Mean · mmHg
Mean Arterial Blood Pressure
mmHgCycloset
Baseline Measurement97 ± 5
Measurement at 4-5 months90 ± 4
SecondaryArterial Stiffness (AS)

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.

Time frame:
Change from baseline to four to five months
Reported as:
Mean · au (arbitrary units)
Arterial Stiffness (AS)
au (arbitrary units)Cycloset
Baseline Measurement19.8 ± 4.1
Measurement at 4-5 months16.2 ± 3.7

Adverse events

Collected over Adverse events were captured from baseline to between 4 to 5 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cycloset2/15 (13.3%)0/15 (0%)2/15 (13.3%)
Most frequent other events
Most frequent other events
EventCycloset
Orthostatic HypotensionCardiac disorders2/15
Light-headednessNervous system disorders2/15
NauseaGastrointestinal disorders2/15
VomitingGastrointestinal disorders2/15

Baseline characteristics

Subjects who were consented and received study intervention

Age, Customized
Age, Customized(years)Cycloset
Participants age57 ± 9
Sex: Female, Male
Sex: Female, Male(Participants)Cycloset
Female11
Male4
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Cycloset
Hispanic or Latino15
Region of Enrollment
Region of Enrollment(participants)Cycloset
United States15
Medications currently used for type 2 diabetes
Medications currently used for type 2 diabetes(Participants)Cycloset
Liraglutide (1.2 - 1.8 mg/d)15
Metformin12
Low dose glargine insulin3
08

Study locations

1 site
  • University of Texas Health Science Center
    San Antonio, Texas 78229, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 3, 2015

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02299050
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
VeroScience
Responsible party
Sponsor
First posted
Nov 24, 2014
Start date
Jun 2014
Primary completion
Apr 30, 2018
Completion
Apr 30, 2018
Results posted
Jun 21, 2019
Last update
Jun 21, 2019

Study contacts

Ralph A DeFronzo, MD
principal investigator · The University of Texas Health Science Center at San Antonio

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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