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

• Sponsor: Sherief Abd-Elsalam (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03313661
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 37.6
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Evaluation of the glycemic efficacy of cabergoline on diabetic patients

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Cabergoline; Drug: Gliclazide	Phase 3

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

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Co-administration of Cabergoline and Gliclazide Improve Glycemic Parameters and Lipid Profile in T2DM Patients
• Actual Study Start Date: Oct 14, 2017
• Anticipated Primary Completion Date: Oct 1, 2020
• Anticipated Study Completion Date: Dec 1, 2020

Arms and Interventions

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 Placebo

Outcome Measures

Primary Outcome Measures

1. The level of fasting and post prandial BG level [4 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Diabetic patients.

Exclusion Criteria:

• Other drugs administration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sherief Abd-Elsalam	Cairo		Egypt

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
• ClinicalTrials.gov Identifier: NCT03313661
• Other Study ID Numbers: Diabetes Mellitus
• First Posted: Oct 18, 2017
• Last Update Posted: Aug 27, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Additional relevant MeSH terms: Gliclazide; Cabergoline

Study Results

No Results Posted as of Aug 27, 2018