Skip to content

Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

This trial does not test a peptide that PepBank tracks.

  • Names Glucagon, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 4
Enrollment
23 participants (actual)
Sponsor
The University of Texas Health Science Center at San Antonio · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jun 2014
Primary completion
30 Apr 2018
Completion
30 Apr 2018
First posted
24 Nov 2014 (estimated)
Last update posted
21 Jun 2019
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016201720182019
  1. Ph 4

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

    NCT02299050

    Jun 2014 to 30 Apr 2018

Registry summary

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

Interventions

  • CyclosetDrug

Arms1

  • Other

    Cycloset

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

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. HbA1C

    Time frame · Change from baseline to four to five months

    Registry description

    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.

  2. Glucose Metabolism During Mixed Meal Tolerance Test

    Time frame · Change from baseline to four to five months

    Registry description

    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.

Secondary outcomes(6)
  1. Endothelial Function,

    Time frame · Change from baseline to four to five months

    Registry description

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

  2. Body Composition

    Time frame · Change from baseline to four to five months

    Registry description

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

  3. Percentage Body Fat

    Time frame · Change from baseline to four to five months

    Registry description

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

  4. Blood Pressure

    Time frame · Change from baseline to four to five months

    Registry description

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

  5. Mean Arterial Blood Pressure

    Time frame · Change from baseline to four to five months

    Registry description

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

  6. Arterial Stiffness (AS)

    Time frame · Change from baseline to four to five months

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Change from baseline to four to five months

HbA1C

GroupValue (mmol/mol)Spread
Cycloset8.30.3
Primary outcomeMean· Change from baseline to four to five months

Glucose Metabolism During Mixed Meal Tolerance Test

GroupValue (mg/kg *min)Spread
Cycloset1.10.1
Secondary and other outcome results(6)
Secondary outcomeMean· Change from baseline to four to five months

Endothelial Function,

GroupValue (mmHg)Spread
Cycloset542
Secondary outcomeMean· Change from baseline to four to five months

Body Composition

GroupValue (kg)Spread
Cycloset88.113.8
Secondary outcomeMean· Change from baseline to four to five months

Percentage Body Fat

GroupValue (percentage body fat)Spread
Cycloset39.16.7
Secondary outcomeMean· Change from baseline to four to five months

Blood Pressure

GroupValue (mmHg)Spread
Cycloset1344
Secondary outcomeMean· Change from baseline to four to five months

Mean Arterial Blood Pressure

GroupValue (mmHg)Spread
Cycloset975
Secondary outcomeMean· Change from baseline to four to five months

Arterial Stiffness (AS)

GroupValue (au (arbitrary units))Spread
Cycloset19.84.1

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther 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-QR2 / 150 / 152 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 30 Years up to 69 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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: * 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

PepBank is a research reference. Talk to a doctor before you use any peptide.