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

Phase 3

• Conditions: Diabetes
• Interventions: Drug: Cabergoline; Drug: Gliclazide

• Registration Number: NCT03313661
• Lead Sponsor: Sherief Abd-Elsalam

Brief Summary

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 Timeline

• Study Start: 2017-10-14
• Study First Submitted: 2017-10-14
• Study First Submitted QC: 2017-10-14
• Study First Posted: 2017-10-18
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-27
• Primary Completion: 2020-10
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diabetic patients.

Exclusion Criteria

• Other drugs administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cabergoline	Cabergoline	cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide
Gliclazide	Gliclazide	gliclazide (60-120 mg) once daily

Primary Outcome Measures

Name	Time	Method
The level of fasting and post prandial BG level	4 months	Fasting and post prandial BG level will be measured after 4 months

Trial Locations

Locations (1)

Sherief Abd-Elsalam; 🇪🇬 Cairo, Egypt