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

Evaluation of the glycemic efficacy of cabergoline on diabetic patients

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Drug: Cabergoline; Drug: Gliclazide

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

• Study Contact: Name: Sherief Abd-Elsalam, consultant; Phone Number: 00201095159522; Email: Sheriefabdelsalam@yahoo.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	Fasting and post prandial BG level will be measured after 4 months	4 months

Collaborators and Investigators

• 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

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: Hypoglycemic Agents; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dopamine Agonists; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Gliclazide; Cabergoline
• 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