Observational Study of Effectiveness and Tolerability of... | NCT04132934

Studies
Observational Study of Effectiveness and Tolerability of Gliclazide MR 60mg in Diabetic Patients Fasting During RAMADAN

NCT04132934

Sponsor

Servier Affaires Médicales

Status

Completed

Last Update Posted

Jun 5, 2020Actual

Enrollment

1,200Actual

Phase

Not provided

Conditions

Type 2 Diabetes

Interventions

Not provided

Countries

France

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2019Actual

Primary Completion Date

Oct 4, 2019Actual

Completion Date

Oct 4, 2019Actual

First Submitted Date

Oct 16, 2019

First Submission Date that Met QC Criteria

Oct 18, 2019

First Posted Date

Oct 21, 2019Actual

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

Jun 3, 2020

Last Update Posted Date

Jun 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this observational study is to assess effectiveness and tolerability of gliclazide MR 60mg during RAMADAN in a real world setting in 9 countries from Asia Pacific and Middle East/North Africa

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients with at least one Hypoglycemia event		up to 5 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent obtained before any trial-related activities
Male or female type 2 diabetic patients aged >18 years
Patients with controlled or suboptimal controlled type 2 diabetes
Patients with experience in SMBG controlling using glucometer
Patients who are willing to fast during Ramadan
Patients already treated with Gliclazide MR 60mg

Exclusion Criteria:

Insulin therapy requirement
Severe liver or renal failure
HbA1c ≥ 9%
Contraindication to gliclazide according to SmPC
Pregnancy or breast feeding
Previous experience of severe or repeated hypoglycemia events without triggered factor within the previous year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with type 2 diabetes observing fast during Ramadan

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Servier Affaires Medicales		Suresnes		92284	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32330510	Result	Hassanein M, Al Sifri S, Shaikh S, Abbas Raza S, Akram J, Pranoto A, Rudijanto A, Shaltout I, Fariduddin M, Mohd Izani Wan Mohamed W, Al Awadi F, Alessa T; DIA-RAMADAN study investigators. A real-world study in patients with type 2 diabetes mellitus treated with gliclazide modified-release during fasting: DIA-RAMADAN. Diabetes Res Clin Pract. 2020 May;163:108154. doi: 10.1016/j.diabres.2020.108154. Epub 2020 Apr 21.
33974216

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases