CompletedPhase 4Results posted

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

Effect of Cycloset on Glycemic Control in Type 2 Diabetic Patients Inadequately Controlled on GLP-1 Analogue Therapy

Lead sponsor

The University of Texas Health Science Center at San Antonio

Assets

Exenatide / Liraglutide

Listed sites

Recruiting sites

Actual enrollment

Study population

Cardiovascular disease, Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI 24-40•HbA1c 7.5-10%

Primary endpoints

•HbA1C•Glucose Metabolism During Mixed Meal Tolerance Test

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02299050

Org study IDHSC20130330H

Timeline

Milestones

Study first posted2014-11-24estimated

Primary completion2018-04-30actual

Study completion2018-04-30actual

Last update posted2019-06-21actual

Results first posted2019-06-21actual

Study start2014-06 (month precision)

Assets

Investigational agents

Exenatide Liraglutide

Who this study enrolls

Cardiovascular diseaseObesity / overweightType 2 diabetes

Who can enroll

Minimum age30 Years

Maximum age69 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Body Composition