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

NCT02299050 | Completed Phase 4 Results DMC

• 1 other identifier: HSC20130330H
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes

Keywords

Type 2 Diabetes; T2DM; Cycloset; Glycemic Control; GLP-1

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from baseline to four to five months

• 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.

  Change from baseline to four to five months

Secondary Outcomes (6)

• Endothelial Function,

  Change from baseline to four to five months

• Body Composition

  Change from baseline to four to five months

• Percentage Body Fat

  Change from baseline to four to five months

• Blood Pressure

  Change from baseline to four to five months

• Mean Arterial Blood Pressure

  Change from baseline to four to five months

Study Arms (1)

Cycloset

OTHER

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

Drug: Cycloset

Interventions

Cycloset DRUG

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

Cycloset

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• VeroScience: collaborator

Study Sites (1)

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Bromocriptine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ergotamines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Ergolines; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Mariam Alatrach
• Organization: University of Texas Health San Antonio

alatrach@uthscsa.edu

210-358-7220

Study Officials

• Ralph A DeFronzo, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: November 24, 2014
• Study Start: June 1, 2014
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: June 21, 2019
• Results First Posted: June 21, 2019

Record last verified: 2019-05

Locations

US (1)