NCT03313661

Brief Summary

Evaluation of the glycemic efficacy of cabergoline on diabetic patients

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3 diabetes

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 27, 2018

Status Verified

August 1, 2018

Enrollment Period

3 years

First QC Date

October 14, 2017

Last Update Submit

August 23, 2018

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • The level of fasting and post prandial BG level

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

    4 months

Study Arms (3)

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

CabergolineDRUG

cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide

Cabergoline
GliclazideDRUG

gliclazide (60-120 mg)

Gliclazide

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patients.

You may not qualify if:

  • Other drugs administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

CabergolineGliclazide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfonylurea CompoundsUreaBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Study Officials

  • 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

    Tanta University

    STUDY CHAIR

  • Gamal Abdel khalek Elazab, Ph D

    Faculty of Pharmacy, Tanta University, Egypt

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, consultant

CONTACT

00201095159522Sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhDTropical Medicine

Study Record Dates

First Submitted

October 14, 2017

First Posted

October 18, 2017

Study Start

October 14, 2017

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

August 27, 2018

Record last verified: 2018-08

Locations

EG(1)