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Cycloset Diabetes

Cycloset, Bromocriptine Mesylate

Cycloset, Bromocriptine Mesylate

Cycloset is a quick release formulation of micronized bromocriptine mesylate (bromocriptine-QR).It is a dopamine receptor agonist. Cycloset is specifically indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Cycloset is supplied as a tablet designed for oral administration. The recommended initial dose of the drug is 1.6 mg to 4.8 mg administered once daily within two hours after waking in the morning. Cycloset should be initiated at one tablet (0.8 mg) and increased by one tablet per week until a maximum daily dose of 6 tablets (4.8 mg) or until the maximal tolerated number of tablets between 2 and 6 per day is reached. The FDA approval of Cyloset was based on the results of four clinical trials; a 24-week monotherapy trial, two 24-week add-on to sulfonylurea trials and a 52-week safety trial. In all four clinical trials, subjects assigned to treatment with Cycloset received an initial dose of 0.8 mg, which was increased by 0.8 mg each week for 6 weeks (4.8 mg/day final dose) if no intolerance occurred or until the maximum tolerated dose > 1.6 mg/day was reached. This 24-week, double-blind, placebo-controlled study enrolled 159 overweight adults with type II diabetes and inadequate glycemic control. The trial was designed to evaluate the efficacy and safety of Cycloset as an adjunct to diet and exercise. Of the 80 subjects in the Cycloset group, 69% (N=55) achieved the maximum daily dose of 4.8 mg. Cycloset improved HbA1c and fasting plasma glucose compared to placebo. Mean HbA1c at baseline was 9.0% in the Cycloset group and 8.8% in the placebo group. The 24-week change from baseline was -0.1 in the Cycloset arm and 0.3 in the placebo arm (a -0.4 difference from placebo; p0.05). The mean baseline fasting p Continue reading >>

Cycloset (bromocriptine Mesylate) Tablets Are A Dopamine Receptor Agonist Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus.

Cycloset (bromocriptine Mesylate) Tablets Are A Dopamine Receptor Agonist Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus.

CYCLOSET should not be used to treat type 1 diabetes or diabetic ketoacidosis. There are limited efficacy data in combination with thiazolidinediones. Efficacy has not been confirmed in combination with insulin. IMPORTANT SAFETY INFORMATION FOR CYCLOSET Do not use CYCLOSET in patients with hypersensitivity to ergot-related drugs, bromocriptine or to any of the excipients in CYCLOSET. Do not use CYCLOSET in patients with syncopal migraines. May precipitate hypotension. Do not use CYCLOSET in nursing women. May inhibit lactation. There have been postmarketing reports of stroke with bromocriptine in this patient population, although causality has not been proven. Based on CYCLOSET clinical trials, there is no evidence of increased risk for stroke when CYCLOSET is used to treat type 2 diabetes. CYCLOSET can cause orthostatic hypotension and syncope, particularly upon initiation or dose escalation. Use caution in patients taking anti-hypertensive medications. Orthostatic vital signs should be assessed prior to initiation of CYCLOSET and periodically thereafter. Advise patients during early treatment to avoid situations that could lead to injury if syncope were to occur, and to make slow postural changes. Pathological gambling and exacerbation of psychotic disorders have been reported with bromocriptine generally given in higher doses than what is approved for diabetes treatment. There have been no reported cases of psychoses or pathological gambling among CYCLOSET-treated patients in clinical trials. The use of CYCLOSET in patients with severe psychotic disorders is not recommended. CYCLOSET may cause somnolence, particularly when initiating therapy. Advise patients not to drive or operate heavy machinery if symptoms of somnolence occur. Concomitant Use of Dopamine Antagoni Continue reading >>

Bromocriptine: A Sympatholytic, D2-dopamine Agonist For The Treatment Of Type 2 Diabetes

Bromocriptine: A Sympatholytic, D2-dopamine Agonist For The Treatment Of Type 2 Diabetes

Bromocriptine: A Sympatholytic, D2-Dopamine Agonist for the Treatment of Type 2 Diabetes Diabetes Division, University of Texas Health Science Center, San Antonio, Texas Corresponding author: Ralph A. DeFronzo, [email protected] . Author information Copyright and License information Disclaimer Copyright 2011 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See for details. This article has been corrected. See Diabetes Care. 2011 June; 34(6): 1442 . This article has been cited by other articles in PMC. Bromocriptine is a sympatholytic D2-dopamine agonist that has been approved for the treatment of type 2 diabetes. Based on animal and human studies, timed bromocriptine administration within 2 h of awakening is believed to augment low hypothalamic dopamine levels and inhibit excessive sympathetic tone within the central nervous system (CNS), resulting in a reduction in postmeal plasma glucose levels due to enhanced suppression of hepatic glucose production. Bromocriptine has not been shown to augment insulin secretion or enhance insulin sensitivity in peripheral tissues (muscle). Addition of bromocriptine to poorly controlled type 2 diabetic patients treated with diet alone, metformin, sulfonylureas, or thiazolidinediones produces a 0.50.7 decrement in HbA1c. Bromocriptine also reduces fasting and postmeal plasma free fatty acid (FFA) and triglyceride levels. In a 52 double-blind, placebo-controlled study in type 2 diabetic patients, bromocriptine reduced the composite cardiovascular end point by 40%. The mechanism of the drugs beneficial effect on cardiovascular disease remains to be determined. Type 2 diabetes is a chronic metabolic disorde Continue reading >>

Cycloset, Parlodel (bromocriptine) Dosing, Indications, Interactions, Adverse Effects, And More

Cycloset, Parlodel (bromocriptine) Dosing, Indications, Interactions, Adverse Effects, And More

Hyperprolactinemia-Associated Dysfunctions (Parlodel) Indicated for treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism; also indicated in patients with prolactin-secreting adenomas 1.25-2.5 mg PO qDay initially; may increase by 2.5 mg/day q2-7Days until optimal therapeutic response achieved Usual therapeutic dosage ranges from 2.5-15 mg/day Up to 30 mg/day has been used in some patients with amenorrhea and/or galactorrhea Indicated as adjunctive treatment to levodopa for the signs and symptoms of idiopathic/postencephalitic Parkinson disease 1.25 mg PO q12hr initially; may increase dose by 2.5 mg/day q2-4Weeks until optimal therapeutic response achieved 1.25-2.5 mg PO qHS for 3 days initially; may increase by 1.25-2.5 mg/day q3-7Days until optimal therapeutic response achieved Quick release formulation (Cycloset) is the only bromocriptine product indicated for diabetes mellitus type 2 as adjunct to diet and exercise to improve glycemic control 0.8 mg PO qDay initially; may increase by 0.8-mg increments qWeek as tolerated Usual dosage ranges between 1.5-4.8 mg PO qDay; not to exceed 4.8 mg (6 tablets)/day Note: Cycloset is not indicated for hyperprolactinemia, Parkinson disease, or acromegaly see Dosage Modifications (Cycloset) and Administratio (Cycloset) Neuroleptic Malignant Syndrome (Off-label, Parlodel) 2.5-5 mg PO 2-3 times/day; not to exceed 45 mg/day [Strawn JR, Keck PE Jr, and Caroff SN, "Neuroleptic Malignant Syndrome," Am J Psychiatry, 2007, 164(6):870-6] Hepatic impairment: Safety and efficacy has not been established; dosage adjustment may be necessary due to extensive hepatic metabolism; use with caution Renal impairment: Safety and efficacy has not been established St Continue reading >>

Fda Approves New Diabetes Drug Cycloset

Fda Approves New Diabetes Drug Cycloset

May 7, 2009 -- The FDA has approved a new drug, called Cycloset, to improve blood sugar control in adults with type 2 diabetes , in addition to diet and exercise . Cycloset takes a new approach to treating type 2 diabetes . It boosts levels of a chemical called dopamine, which helps nerve cells communicate. Cycloset is taken orally in the morning, within two hours of waking, and with food. It's not clear how Cycloset improves glycemic control in humans. But studies in diabetic animals show that boosting dopamine activity at a particular time of day can "reset" the biological clock to improve metabolism problems related to diabetes , according to VeroScience, the company that developed Cycloset. In a yearlong trial of 3,070 adults with type 2 diabetes , Cycloset trumped a placebo at improving HbA1c levels, which gauge blood sugar control, over the previous two to three months. In that trial, 39% of patients taking Cycloset met the HbA1c goal, compared to 11% of patients taking the placebo. In addition, patients taking Cycloset were less likely to have a heart attack or stroke , or to die of heart disease . During the clinical trial , 24% of the patients in the Cycloset group dropped out of the study, compared to 15% of the patients taking placebo. Gastrointestinal side effects, particularly nausea , were the main reason patients taking Cycloset quit the study. The most commonly reported adverse events were nausea, fatigue , vomiting , headache , and dizziness . None of those cases was serious, and side effects were more likely to happen when patients first started taking Cycloset. Cycloset's active ingredient, bromocriptine mesylate, isn't a new drug. It's been used in other formulations to treat conditions including Parkinson's disease , usually at higher doses, accord Continue reading >>

Steps: Bromocriptine Mesylate (cycloset) For Type 2 Diabetes Mellitus - American Family Physician

Steps: Bromocriptine Mesylate (cycloset) For Type 2 Diabetes Mellitus - American Family Physician

0.8 mg once daily in the morning (within two hours of waking); maximal daily dosage: 4.8 mg *Estimated retail price of one month's treatment based on information obtained at (accessed February 12, 2013). Cycloset is not associated with an increased risk of cardiovascular events. 2 Hypotension develops in about one in 50 patients. Persons treated concurrently with antihypertensive medications should be warned to report symptoms such as dizziness, nausea, or diaphoresis if they occur. 1 Cycloset should not be used in patients who have a history of syncopal migraine. Hypoglycemia may occur in about 4 percent of patients when Cycloset is used alone, and in about 9 percent of patients when it is combined with a sulfonylurea. Severe hypoglycemia requiring medical treatment is uncommon. Cycloset has not been studied in children or patients with hepatic or renal insufficiency. It is a U.S. Food and Drug Administration pregnancy category B drug. Cycloset is extensively metabolized by the cytochrome P450 3A4 liver enzyme system. Potent inhibitors (e.g., macrolide antibiotics, azole antifungals) or inducers (e.g., rifampin, carbamazepine [Tegretol], phenytoin [Dilantin]) of this enzyme may affect serum levels and possibly the action of Cycloset. Because its use with dopamine receptor antagonists (i.e., metoclopramide [Reglan], clozapine [Clozaril], and olanzapine [Zyprexa]) has not been studied, it should not be used concurrently with these agents. Cycloset is highly protein-bound, and can alter the effectiveness and increase adverse effects of salicylates, sulfonamides, chloramphenicol, and probenecid. About one in four patients will stop treatment with Cycloset because of adverse effects. Nausea, fatigue, dizziness, vomiting, and headaches can occur in up to one-third of patien Continue reading >>

Dopamine Agonist: Cycloset (bromocriptine)

Dopamine Agonist: Cycloset (bromocriptine)

Dopamine Agonist: Cycloset (Bromocriptine) Bromocriptine is a dopamine D2 receptor agonist approved by the U.S. FDA in 2009 for treatment of type 2 diabetes patients under the trade name Cycloset. Cycloset is a quick-release formulation of bromocriptine. Unlike other medications for type 2 diabetes, Cycloset increases dopamine receptor activity in the morning, which lowers blood sugarwithout increasing insulin [1] . Bromocriptine has been in use for decades for treatment of pituitary tumors , Parkinsons disease (PD), hyperprolactinaemia , and neuroleptic malignant syndrome . The idea of using bromocriptine for the treatment of type-2 diabetes came while studying the metabolism of migrating birds ; that they develop seasonal insulin resistance and dopamine plays a role in it. Researchers found that Bromocriptine improves glycemic control lowering HbA1c levels by ~0.5%. Although the exact way bromocriptine works is still unclear, some possible mechanisms by which bromocriptine reduces glucose levels include suppression of endogenous glucose production and/or increased splanchnic glucose uptake after glucose ingestion. The most common adverse side effects associated with bromocriptine are nausea, fatigue, dizziness, vomiting and headache. The drug is also known to be associated with nasal stuffiness, nausea, headache, constrictive pericarditis,neuroleptic malignant syndrome and hypotension. The incidence of hypoglycemia was 6.9% among type 2 diabetes patients treated with bromocriptine compared to 5.3% of type 2 diabetes patients receiving placebo. Because it has a modest glucose lowering effect and frequent abdominal side effects, it is seldomly prescribed in patients with type 2 diabetes. Bromocriptine should not be used by type 1 diabetes patients. For more information Continue reading >>

Cycloset (bromocriptine Mesylate) Is A Once-daily Prescription Pill Used With Diet And Exercise To Lower Blood Sugar Levels In Adults With Type 2 Diabetes.

Cycloset (bromocriptine Mesylate) Is A Once-daily Prescription Pill Used With Diet And Exercise To Lower Blood Sugar Levels In Adults With Type 2 Diabetes.

Are allergic to bromocriptine or any of the other ingredients in CYCLOSET Have fainting (syncopal) migraine headaches or take medicines for migraines called ergots. Ask your health care provider or pharmacist for a list of these medicines, if you are not sure whether you take any. Before taking CYCLOSET, tell your health care provider about all medical conditions, including if you: Have type 1 diabetes mellitus or diabetic ketoacidosis Have or have had low blood pressure (hypotension) Have or have had a mental health condition, especially a psychotic disorder Are pregnant or plan to become pregnant. It is not known if CYCLOSET will harm your unborn baby. Talk with your health care provider if you are pregnant or plan to become pregnant. Tell your health care provider about all medicines you take (prescription, non-prescription, vitamins and supplements), especially those for: Mental health conditions, especially anti-psychotic medicines CYCLOSET may cause serious side effects, including: Low blood pressure, fainting, or severe dizziness after you stand up from a sitting or lying position The most common side effects of CYCLOSET include: Fatigue (somnolence) if you have somnolence, do not drive or use other heavy equipment until the somnolence is better Low blood sugar (hypoglycemia), especially when used with another type of diabetes medicine known as a sulfonylurea Tell your health care provider if you have any side effect that bothers you or that does not go away. You are encouraged to report negative side effects of prescription drugs. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please click here for full Prescribing Information, including Patient Information. Continue reading >>

What Is Cycloset? - Goodrx

What Is Cycloset? - Goodrx

Cycloset discount prices start at just $126.41! Commonly Used Brand Name(s)Cycloset, Parlodel Bromocriptine belongs to the group of medicines known as ergot alkaloids. Bromocriptine blocks the release of a hormone called prolactin from the pituitary gland. Prolactin affects the menstrual cycle and milk production. Bromocriptine is used to treat certain menstrual problems (eg, amenorrhea ) in women and stops milk production in some men and women who have abnormal milk leakage. It is also used to treat infertility in both men and women that occurs because the body is making too much prolactin. Bromocriptine is also used to treat acromegaly (overproduction of growth hormone) and pituitary prolactinomas (tumors of the pituitary gland). Bromocriptine is also used to treat the signs and symptoms of Parkinson's disease , often in combination with levodopa. Bromocriptine is also used together with proper diet and exercise to lower blood sugar levels in patients with type 2 diabetes . This medicine is available only with your doctor's prescription. Find big savings at pharmacies near you with GoodRx discount coupons Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Cycloset comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions. Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed. Take Cycloset within 2 hours after you wake up in the morning. Take Parlodel at bedtime to help lessen nausea if Continue reading >>

Novel Diabetes Drug Cycloset Approved

Novel Diabetes Drug Cycloset Approved

Last week, the U.S. Food and Drug Administration (FDA) approved a new drug for treating Type 2 diabetes. Called Cycloset, the drug is actually a new version of the older drug bromocriptine, which has been used at higher doses to treat people with Parkinson disease. The new drug, which is to be taken once a day, within two hours of waking up, with food, has been shown to lower HbA1c levels (a measure of average blood glucose) in people with Type 2 diabetes more than a placebo . In a year-long study of over 3,000 adults, 39% of people taking Cycloset reached the studys HbA1c goal, compared to 11% of people who took the placebo. According to Cyclosets press materials, studies have also shown that one daily dose of the drug helps lower postmeal rises in peoples blood glucose levels all day. According to animal studies, Cycloset works by boosting the activity of a chemical called dopamine in the brain. This, in turn, resets the bodys biological clock to help control its metabolism. Studies of the biological clocks of migrating birds and hibernating animals, which become more insulin resistant during certain times of the year, helped inspire this drugs development. People taking Cycloset in the 3,000-person study were also less likely to have a heart attack or stroke or to die of heart disease while taking the drug. Earlier this year, the FDA tightened heart-safety standards for new diabetes drugs (check out the Diabetes Flashpoints feature FDA: Stifler or Savior? for more details about this decision). When this drug will reach the market is unclear, since its manufacturer, VeroScience, Inc., is a small company. An interesting article about this drugs 20-plus year journey from laboratory to market appeared last week in The Boston Globe. Disclaimer of Medical Advice: You unde Continue reading >>

Cycloset

Cycloset

Cycloset is a prescription medicine approved for the treatment of diabetes. Specifically, it is used in combination with diet and exercise to help control blood sugar in people with type 2 diabetes. The medication comes in tablet form and is usually taken within two hours after waking in the morning. Some of the common side effects of this drug include dizziness, vomiting, and fatigue. Cycloset ( bromocriptine mesylate) is a prescription diabetes medication . It is approved to be used together with diet and exercise to help control blood sugar in people with type 2 diabetes . (Click Cycloset Uses for more information on what the medication is used for, including possible off-label uses.) Cycloset is made by Patheon, Inc. for VeroScience LLC. Cycloset belongs to a group of medications known as ergot alkaloids. It works as a dopamine receptor agonist, which means that it binds to and stimulates dopamine receptors. Dopamine is a neurotransmitter (a chemical that transmits signals between nerves). It is not entirely clear how Cycloset works to control blood sugar, but it is thought that stimulating dopamine receptors in the brain at certain times of the day "resets" the biological clock and improves metabolism. It is thought that seasonal changes in the metabolism of wild animals are due to similar mechanisms. For years, bromocriptine (the active ingredient in Cycloset) has been used to treat Parkinson's disease , acromegaly (a growth disorder), and hyperprolactinemia (a hormone disorder). Only recently has it been approved for treating diabetes . Continue reading >>

Cycloset Approved By Fda

Cycloset Approved By Fda

In early May, a drug called Cycloset (also known as bromocriptine) was approved by the FDA for use in type 2 diabetes. Cycloset, developed by VeroScience, works in the brain to simulate the action of a chemical called dopamine (a neurotransmitter). It is the first drug in its class approved for the treatment of diabetes and (even more exciting for us!) the first drug approved under the FDAs new cardiovascular guidelineswhich you can read about in this issues Learning Curve. While the mechanism of action of dopamine in diabetes is not completely clear, the concept for the drug originated after scientists at VeroScience noticed that, while animals become obese and insulin resistant during annual periods of hibernation or migration, they automatically revert to a non-obese non-insulin resistant state when the next season arrives with no apparent side effects. After a careful analysis of brain signals from hibernating and non-hibernating animals, VeroScience noticed a variation of dopamine levels that might account for this pre-diabetes/non-diabetes transformation. Cycloset aims to take advantage of this brain chemistry by attempting to mimic mother nature in reversing diabetes. Cycloset is a once-daily therapy to be taken in the morning. It has been approved as a monotherapy (to be taken by itself) as well as with a sulfonylurea or metformin. In phase 3 trials, Cycloset produced an A1c decrease of about 0.7% after 24 weeks, without any increase in serious side effects. We are impressed by its side effect profile and mechanism of action, and think it may be a good alternative treatment for some people with diabetes. Ultimately, some experts think it may be shown to be cardioprotective (reduce the risk of heart disease), though that would need to be proven in long-term tria Continue reading >>

Santarus Announces Commercial U.s. Launch Of Cycloset For Type 2 Diabetes Mellitus

Santarus Announces Commercial U.s. Launch Of Cycloset For Type 2 Diabetes Mellitus

Santarus announces commercial U.S. launch of CYCLOSET for type 2 diabetes mellitus Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced the commercial U.S. launch of CYCLOSET (bromocriptine mesylate) tablets. CYCLOSET is a prescription drug approved by the U.S. Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus both as monotherapy and in combination with other oral antidiabetic agents. We are pleased to announce that CYCLOSET is now available through retail pharmacies "We are pleased to announce that CYCLOSET is now available through retail pharmacies," said Gerald T. Proehl, president and chief executive officer of Santarus. "Our commercial organization, which includes approximately 110 sales representatives, is excited about the addition of CYCLOSET with its novel approach to treating patients with type 2 diabetes and the overlap with our current called-on physicians for GLUMETZA. Our promotion focuses on CYCLOSET's consistent glycemic control and cardiovascular safety, which were demonstrated in a 3,070-patient clinical study." Ralph A. DeFronzo, M.D., Professor of Medicine, Chief of the Diabetes Division, University of Texas Health Sciences Center, San Antonio, said, "CYCLOSET represents a new treatment for adults with type 2 diabetes. Although the mechanism by which CYCLOSET improves glycemic control is unknown, it contains bromocriptine mesylate, which increases dopaminergic activity in the hypothalamus. In a clinical trial, CYCLOSET lowered HbA1c by 0.6% to 0.9% relative to placebo, when added to other oral antidiabetic agents. CYCLOSET can be prescribed for adults who are inadequately controlled with diet/exercise, metformin, sulfonylureas or Continue reading >>

Dopamine-2 Agonists (bromocriptine, Cycloset)

Dopamine-2 Agonists (bromocriptine, Cycloset)

Bromocriptine helps people with type 2 diabetes by suppressing the liver from putting sugar into the bloodstream in a process called gluconeogenesis. Currently, Bromocriptine, marketed as Cycloset is the only FDA approved dopamine-2 agonist for treatment of type 2 diabetes though it is used to treat many other conditions. Gluconeogenesis is what happens each morning before we awake to get the body some energy in order to get up and get going. Our body uses non-carbohydrate sources like amino acids in our liver and turns those into glucose. This works well in non-diabetic bodies but when it happens to people with diabetes who already have extra sugar in their bloodstream, the result is high blood sugar. So bromocriptine helps to combat this effect. An article published in the American Diabetes Association’s journal Diabetes Care states that in patients with poorly controlled diabetes treated with bromocriptine in addition to diet, metformin, sulfonylureas, or thiazolidinediones produces a slight lowering of A1c levels by 0.5% to 0.7%. In addition, bromocriptine also lowers fasting and after meal plasma free fatty acid and triglyceride levels. There was a one year prospective study which showed bromocriptine also lowered cardiovascular events (e.g. heart attacks). The image below from the Indian Journal of Endocrinology and Metabolism shows how bromocriptine (Cycloset) works: The National Health Institute (NIH) states that if you take bromocriptine (Cycloset) once a day and miss your dose, then take your next dose the next morning and be sure to never double dose to make up for a missed one. It comes as a tablet to take by mouth usually once a day with food and within 2 hours of waking. Take around the same time each day. Cautions and Side Effects of Bromocriptine (Cycl Continue reading >>

Safety And Tolerability Study Of Cycloset In Treatment Of Type 2 Diabetes

Safety And Tolerability Study Of Cycloset In Treatment Of Type 2 Diabetes

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Safety and Tolerability Study of Cycloset in Treatment of Type 2 Diabetes 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. ClinicalTrials.gov Identifier: NCT00377676 Information provided by (Responsible Party): Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Cycloset, a new quick-release oral formulation of bromocriptine mesylate, effectively reduces blood sugar by the proposed mechanism of reversing many of the metabolic alterations associated with insulin resistance and obesity by resetting central (hypothalamic) circadian organization of monoamine neuronal activities. The primary analysis of this study will test the hypothesis that the rate of all-cause severe adverse events for those receiving usual drug therapy for diabetes management plus Cycloset is not greater than that for usual drug therapy plus placebo by more than an acceptable margin. While the primary purpose of this study is to establish the safety profile of Cycloset in type 2 diabetes, any potential positive cardiovascular benefits will be evaluated as well. Drug: Cycloset Drug: Usual Diabetes Therapy plus placebo Bromocriptine mesylate, an ergot derivative, is a sympatholytic dopamine D2 receptor agonist that can exert inhibitory effects on serotonin turnover in the central nervous system. It has been proposed that bromocriptine can reverse many of the metabolic alterations associated with insulin resistance and obesity Continue reading >>

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