Co-administration of Cabergoline and Gliclazide Improve G... | NCT03313661

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

NCT03313661

Sponsor

Sherief Abd-Elsalam

Status

Unknown status

Last Update Posted

Aug 27, 2018Actual

Enrollment

60Estimated

Phase

Phase 3

Conditions

Diabetes

Interventions

Cabergoline
Gliclazide

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2017Actual

Primary Completion Date

Oct 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Oct 14, 2017

First Submission Date that Met QC Criteria

Oct 14, 2017

First Posted Date

Oct 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2018

Last Update Posted Date

Aug 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cabergoline	Experimental	cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide	Drug: Cabergoline
Gliclazide	Active Comparator	gliclazide (60-120 mg) once daily	Drug: Gliclazide
Placebo	No Intervention	Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cabergoline	Drug	cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide	Cabergoline

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diabetic patients.

Exclusion Criteria:

Other drugs administration

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sherief Abd-Elsalam, consultant	Contact	00201095159522		Sheriefabdelsalam@yahoo.com

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sherief Abd-Elsalam	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077465	Cabergoline
D005907	Gliclazide

Ancestor Terms

ID	Term
D004873	Ergolines
D004876	Ergot Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided