DiabetesPhase 3NCT03313661
Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients
A Phase 3 study testing Cabergoline and Gliclazide in people with Diabetes, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Evaluation of the glycemic efficacy of cabergoline on diabetic patients Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Cabergoline and Gliclazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Oct 2017to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Diabetic patients.
Who cannot join
- Other drugs administration
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Cairo
Sherief Abd-elsalam, lecturer, 00201000040794, Sherif_tropical@yahoo.com
About this study
Evaluation of the glycemic efficacy of cabergoline on diabetic patients
Read the detailed description
Type 2 diabetes mellitus (DM) is a progressive metabolic disorder that is associated with basal hyperinsulinemia, insulin resistance and impaired insulin release. Glycemic control is a fundamental part of the management of type 2 DM and difficult to achieve. Different antidiabetic agents can handle diabetic metabolic abnormalities. The development of antidiabetic agentswith novel mechanisms of action is highly desirable. Cabergoline, a long acting D2 agonist, is expected to play a role in the glycemic control.
- Conditions
- Diabetes
- Being tested
- Cabergoline, Gliclazide
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabergolineDrug
cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide
GliclazideDrug
gliclazide (60-120 mg)
| Study group | Role | What they receive |
|---|---|---|
| Cabergoline | Experimental | cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide Receives: Drug: Cabergoline |
| Gliclazide | Active comparator | gliclazide (60-120 mg) once daily Receives: Drug: Gliclazide |
| Placebo | No intervention | Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of fasting and post prandial BG level
Fasting and post prandial BG level will be measured after 4 months
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2017
- Study start14 Oct 2017
- Primary completionOct 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Jouliana Atef Morcos, Msc, Study chair, Faculty of Pharmacy, Tanta University, EgyptAbla Mohamed Ebeid, Ph D, Study chair, Faculty of Pharmacy, AL-Delta University, Gamasa, EgyptSamy Abdel kader khodeir, Ph D, Study chair, Tanta UniversityGamal Abdel khalek Elazab, Ph D, Study chair, Faculty of Pharmacy, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313661
- Sponsor's protocol ID
- Diabetes Mellitus
- Status last verified
- Aug 2018
- First submitted
- 14 Oct 2017
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients
- ClinicalTrials.gov ID
- NCT03313661
- Acronym / sponsor ID
- Diabetes Mellitus
- Conditions
- Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 14 Oct 2017 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the glycemic efficacy of cabergoline on diabetic patients
Detailed description
Type 2 diabetes mellitus (DM) is a progressive metabolic disorder that is associated with basal hyperinsulinemia, insulin resistance and impaired insulin release. Glycemic control is a fundamental part of the management of type 2 DM and difficult to achieve. Different antidiabetic agents can handle diabetic metabolic abnormalities. The development of antidiabetic agentswith novel mechanisms of action is highly desirable. Cabergoline, a long acting D2 agonist, is expected to play a role in the glycemic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cabergoline | Experimental | Drug: Cabergolinecabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide |
| Gliclazide | Active comparator | Drug: Gliclazidegliclazide (60-120 mg) once daily |
| Placebo | No intervention | –Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients.
Key exclusion criteria (1 listed)
- Other drugs administration
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 |
|---|---|---|
| Cabergolinecabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide | Drug | Cabergoline |
| Gliclazidegliclazide (60-120 mg) | Drug | Gliclazide |
Primary outcome
The level of fasting and post prandial BG level
Time frame: 4 months
Fasting and post prandial BG level will be measured after 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jouliana Atef Morcos, Msc study chair
Faculty of Pharmacy, Tanta University, Egypt
Abla Mohamed Ebeid, Ph D study chair
Faculty of Pharmacy, AL-Delta University, Gamasa, Egypt
Samy Abdel kader khodeir, Ph D study chair
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cabergoline and Gliclazide in people with Diabetes, run by Sherief Abd-Elsalam at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, consultant (00201095159522, Sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of fasting and post prandial BG level (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2018.