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Effect of Cycloset on Glycemic Control When Added to GLP-1 Analogue Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02299050
First Posted: November 24, 2014
Last Update Posted: July 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
VeroScience
Information provided by (Responsible Party):
Ralph DeFronzo, The University of Texas Health Science Center at San Antonio
  Purpose

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 (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


Condition Intervention Phase
Type 2 Diabetes Drug: Cycloset Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Cycloset on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled on GLP-1 Analogue Therapy

Resource links provided by NLM:


Further study details as provided by Ralph DeFronzo, The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • HbA1C [ Time Frame: 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.

    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: 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.


Secondary Outcome Measures:
  • Endothelial Function, [ Time Frame: four and one half months ]
    To assess the potential beneficial effect of Cycloset on endothelial function.

  • Body composition [ Time Frame: four and one half months ]
    To assess the potential beneficial effect of Cycloset on body weight composition.

  • Blood pressure [ Time Frame: four and one half months ]
    To assess the potential beneficial effect of Cycloset on blood pressure.

  • Oxidative stress [ Time Frame: four and one half months ]
    To assess the potential beneficial effect of Cycloset on oxidative stress.

  • Arterial Stiffness [ Time Frame: four and one half months ]
    To assess the potential beneficial effect of Cycloset on artierial stiffness.

  • Inflammation [ Time Frame: four and one half months ]
    To assess the potential beneficial effect of Cycloset on inflammation.


Enrollment: 20
Study Start Date: June 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cycloset

Drug - Cycloset Cycloset 2.4 -3.2 mg/day

Other Names:

Bromocriptine Mesylate Quick Release

Drug: 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
Other Name: Bromocriptine Mesylate Quick Release

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 A1C 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, 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02299050


Locations
United States, Texas
University of Texas Health Science Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
VeroScience
Investigators
Principal Investigator: Ralph A DeFronzo, MD The University of Texas Health Science Center at San Antonio
  More Information

Responsible Party: Ralph DeFronzo, Professor of Medicine, Chief of Diabetes, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02299050     History of Changes
Other Study ID Numbers: HSC20130330H
First Submitted: September 16, 2014
First Posted: November 24, 2014
Last Update Posted: July 18, 2017
Last Verified: July 2017

Keywords provided by Ralph DeFronzo, The University of Texas Health Science Center at San Antonio:
Type 2 Diabetes
T2DM
Cycloset
Glycemic Control
GLP-1

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bromocriptine
Antiparkinson Agents
Anti-Dyskinesia Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action