Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin

A Phase 3 study testing Bromocriptine Mesylate in people with Type 2 Diabetes, run by VeroScience.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: Bromocriptine Mesylate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: No sites listed yet
Study dates: Feb 2005to Mar 2006
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with type 2 diabetes mellitus, for at least six months prior to screening.
18-75 years of age, inclusive.
Male or if female, is either:
postmenopausal or
of childbearing potential and has used appropriate contraceptive methods
Treated with a stable dose of metformin at least 3 months.

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Has not been treated with a sulfonylurea, thiazolidinedione, meglitinide, alpha-glucosidase inhibitor, or combination oral anti-diabetic therapy within 3 months prior to screening.
Has not been on a regimen of lipid-lowering agents or if on such a regimen, it has been stable for a minimum of 6 weeks at screening.
HbA1c value between ≥ 7.5% and < 11%, at screening (Visit 1) and Visit 3.
Fasting plasma glucose measurement of ≤260 mg/dL at screening (Visit 1) and Visit 3.
Fasting C-peptide value equal to or greater than the normal accepted minimum value (e.g. < 0.9 NG/ml).
Stable body weight, i.e., not varying by > 10% for at least3 months prior to screening
Body mass index (BMI) at screening of 25 kg/m2 to 42 kg/m2,inclusive.
If treated for hypertension, the individual has been on stable therapy for 1 month prior to screening.

Who cannot join

Prior exogenous insulin therapy as part of an outpatient diabetes treatment regimen.
Type 1 diabetes mellitus
Clinically significant history of cardiac disease or presence of cardiac disease, including MI, clinically significant arrhythmia, unstable angina pectoris, moderate to severe congestive heart failure, CABG, or angioplasty; or expected to require CABG or angioplasty during the study.
Uncontrolled hypertension, defined as systolic blood pressure > 160 or diastolic blood pressure > 100 mmHg measured in sitting position at screening(Visit 1)
Clinically significant history or presence of:
Hepatic disease (i.e. impaired liver function, including having AST or ALT greater than three times the upper limit of normal)

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Renal disease (i.e. renal impairment with a serum creatinine ≥ 1.4 mg/dl)
Central nervous system disease, including epilepsy
CVA within the last 3 years.
Less than 5 years remission from clinically significant malignancy.
Major surgical operation within 3 months of screening.
Organ transplantation.
Evidence of acute or chronic illness including known or suspected HIV,HBV, or HCV infection.
Currently abuses drugs or alcohol, including binge drinking, or history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
Regularly uses medications with addictive potential such as opiates,narcotics, tranquilizers, etc.
Used drugs for weight loss, e.g., Xenical® (orlistat), Meridia® (sibutramine),Acutrim® (phenylpropanolamine), or similar over-the-counter medications within 3 months of screening.
Known hypersensitivity to any components of the study drugs.
Received any experimental drug or used an experimental device within 3 months of screening or will do so during the study.
Has received unstable dose of fibric acid derivatives within 3 months of the screening.
Requires regular use of systemic corticosteroids by oral, intravenous (IV),or intramuscular (IM) route, or regular use of potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption.
Prescription sympathomimetic drugs within 7 days of screening.
Started therapy with an erectile dysfunction drug within 2 weeks prior to screening. The subject may not begin treatment with an erectile dysfunction drug during the study period; subjects previously taking erectile dysfunction drugs should do so only under medical supervision.
Donated blood within 60 days of screening. Donation of blood also is prohibited during the study and for 30 days after completion of the study.
Occupation that requires a rotation of shift work or working over night shifts.

About this study

Official title: A Randomized, Double-Blind, Parallel-Group Trial to Assess the Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin in Patients With Type 2 Diabetes Mellitus

Read the detailed description

In the previously conducted Phase III clinical trials, Cycloset® (up to a maximum dose of 4.8 mg/day), administered either as monotherapy or combined with sulfonylurea therapy, significantly reduced HbA1c, fasting and post-prandial glucose and fasting and post-prandial triglycerides in obese individuals with type 2 diabetes mellitus. Clinical studies that combined Cycloset® with metformin were not as part of the original Cycloset® clinical program because metformin was not commercially available in the United States at the time that the studies were initiated. The present study is designed to investigate the efficacy and safety of Cycloset® compared to placebo when added to metformin monotherapy in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.

A sufficient number of individuals will be screened to enroll up to 326 subjects;approximately 276 subjects are expected to complete treatment through study termination (Week 26). The study population will consist of individuals currently treated with metformin, for at least 3 months prior to the study start. Subjects who have ever received exogenous insulin therapy as part of an outpatient diabetes treatment regimen are to be excluded, as are those taking oral anti-diabetic agents other than metformin within 3 months of screening (e.g., sulfonylureas, thiazolidinediones,alpha-glucosidase inhibitors, or meglitinides). Subjects may be male or female(surgically sterile, postmenopausal, or using appropriate contraceptive methods if of childbearing potential), age 18 to 75 years, inclusive, and are to have a screening HbA1c value of ≥ 7.5% and <11.0% and a screening body mass index (BMI) in the range of 25 kg/m2 to 42 kg/m2, inclusive.

Conditions: Type 2 Diabetes
Being tested: Bromocriptine Mesylate
Keywords: diabetes, diabetes mellitus
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bromocriptine MesylateDrug
Also called Cycloset
0.8 mg tablet

Study groups in NCT00441363
Study group	Role	What they receive
Bromocriptine Mesylate	Active comparator	Bromocriptine mesylate 0.8 mg Receives: Drug: Bromocriptine Mesylate
Placebo	Placebo comparator	Bromocriptine mesylate 0.8 mg matching placebo Receives: Drug: Bromocriptine Mesylate

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Baseline to End of Study in HbA1c
Too few subjects were enrolled to assess outcome to pre-specified statistical power.
Measured: up to 24 weeks

Secondary outcomes (2)

Fasting Plasma Glucose and Lipids
Measured: up to 24 weeks
Number of Serious Adverse Events Experienced by the Subjects
Measured: up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2005Mar 2006

First posted28 Feb 2007 (estimated)
Study startFeb 2005
Primary completionFeb 2006
Study completionMar 2006

Why it stopped: Failure to Recruit in a Timely manner

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00441363
Sponsor's protocol ID: 165-AD-04-03-US-2
Status last verified: Apr 2016
First submitted: 27 Feb 2007
Last updated: 9 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Parallel-Group Trial to Assess the Efficacy and Safety of Cycloset® Compared With Placebo When Added to Metformin in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00441363
Acronym / sponsor ID: 165-AD-04-03-US-2
Conditions: Type 2 Diabetes
Keywords: diabetes, diabetes mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Failure to Recruit in a Timely manner
Enrolment: 66 participants (actual)
Lead sponsor: VeroScienceIndustry (pharma, biotech, devices)
Study start: Feb 2005
Primary completion: Feb 2006 (actual)
Study completion: Mar 2006 (actual)
First posted: 28 Feb 2007 (estimated)
Results: Posted 9 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Bromocriptine Mesylate	Active comparator	Drug: Bromocriptine MesylateBromocriptine mesylate 0.8 mg
Placebo	Placebo comparator	Drug: Bromocriptine MesylateBromocriptine mesylate 0.8 mg matching placebo

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Diagnosed with type 2 diabetes mellitus, for at least six months prior to screening.
18-75 years of age, inclusive.
Male or if female, is either:
Treated with a stable dose of metformin at least 3 months.
Has not been treated with a sulfonylurea, thiazolidinedione, meglitinide, alpha-glucosidase inhibitor, or combination oral anti-diabetic therapy within 3 months prior to screening.

Key exclusion criteria (24 listed)

Prior exogenous insulin therapy as part of an outpatient diabetes treatment regimen.
Type 1 diabetes mellitus
Clinically significant history of cardiac disease or presence of cardiac disease, including MI, clinically significant arrhythmia, unstable angina pectoris, moderate to severe congestive heart failure, CABG, or angioplasty; or expected to require CABG or angioplasty during the study.
Uncontrolled hypertension, defined as systolic blood pressure > 160 or diastolic blood pressure > 100 mmHg measured in sitting position at screening(Visit 1)
Hepatic disease (i.e. impaired liver function, including having AST or ALT greater than three times the upper limit of normal)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bromocriptine MesylateAlso: Cycloset0.8 mg tablet	Drug	Bromocriptine Mesylate, Placebo

Primary outcome

Change in Baseline to End of Study in HbA1c
Time frame: up to 24 weeks
Too few subjects were enrolled to assess outcome to pre-specified statistical power.

2 secondary outcomes

Fasting Plasma Glucose and Lipids
Time frame: up to 24 weeks
Number of Serious Adverse Events Experienced by the Subjects
Time frame: up to 24 weeks

Results and safety

Results posted to the registry on 9 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cycloset	32	15
Placebo	34	19

Primary outcome: Change in Baseline to End of Study in HbA1c

Time frame: up to 24 weeks. Mean (Standard Deviation). Unit: % HbA1c

Measure	Cycloset n = 32	Placebo n = 34
Value	-0.4 (.95)	-.5 (0.87)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cycloset	1 of 32 (3.1%)	20 of 32 (62.5%)	Not reported
Placebo	0 of 34 (0%)	14 of 34 (41.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes

RecruitingObservational study
An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruiting
Enhancing Telemedicine for T2D
Type 2 Diabetes
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Richard E Scranton, MD study director

VeroScience

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bromocriptine Mesylate in people with Type 2 Diabetes, run by VeroScience.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Baseline to End of Study in HbA1c (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00441363.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2016.