Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients

August 23, 2018 updated by: Sherief Abd-Elsalam
Evaluation of the glycemic efficacy of cabergoline on diabetic patients

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Sherief Abd-Elsalam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic patients.

Exclusion Criteria:

  • Other drugs administration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cabergoline
cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide
Drug: Cabergoline
cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide
Active Comparator: Gliclazide
gliclazide (60-120 mg) once daily
Drug: Gliclazide
gliclazide (60-120 mg)
No Intervention: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sherief Abd-Elsalam

Investigators

  • Study Chair: Jouliana Atef Morcos, Msc, Faculty of Pharmacy, Tanta University, Egypt
  • Study Chair: Abla Mohamed Ebeid, Ph D, Faculty of Pharmacy, AL-Delta University, Gamasa, Egypt
  • Study Chair: Samy Abdel kader khodeir, Ph D, Faculty of medicine, Tanta University
  • Study Chair: Gamal Abdel khalek Elazab, Ph D, Faculty of Pharmacy, Tanta University, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2017

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

October 14, 2017

First Submitted That Met QC Criteria

October 14, 2017

First Posted (Actual)

October 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diabetes mellitus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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