Observational Cohort Study Evaluating the Effectiveness of an Education Program (NGAYDAUTIEN) in Combination With Gliclazide MR in the Management of Uncontrolled Type 2 Diabetic Patients.

NCT06704802 | Completed

• 1 other identifier: DIM-05762-006
• Study Type: observational
• Target: 678
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the change of HbA1c level from baseline after a 6-month follow up among uncontrolled patients with T2D who will be initiated to Diamicron® MR 60 (originator product) plus an educational program (NGAYDAUTIEN) as monotherapy or in add on to metformin in comparison to an initiation of an Oral Antidiabetic Drug (OAD) (except Diamicron®) as monotherapy or in add on to metformin.

Conditions

Type 2 Diabetes

Keywords

observational; HbA1c; type 2 diabetes; Diamicron® MR 60; T2D; patient educational program

Outcome Measures

Primary Outcomes (1)

• change of HbA1c level (measured in %) from baseline after a 6-month follow-up among the 2 arms

  from baseline to 6-month follow-up

Study Arms (2)

Diamicron® MR 60 (originator product) plus educational program

uncontrolled patients with T2D who will be initiated to Diamicron® MR 60 (originator product) plus an educational program

other OAD except Diamicron®

uncontrolled patients with T2D who will be initiated other OAD except Diamicron®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female who have a diagnosis of uncontrolled T2D and who initiate a new OAD monotherapy or on top of metformin

You may qualify if:

• Aged at least 18 years (without upper limit of age)
• HbA1c value is required at the baseline visit
• Patients with diagnosis of uncontrolled T2D
• Initiation of a new OAD as monotherapy or on top of metformin
• Patient follow-up within the scope of the current medical practice and in the same health center during the 6-month period.

You may not qualify if:

• Diagnosis of diabetes other than T2D
• HbA1c value not available at baseline
• Patients who previously attended to the NDT educational program for T2D management
• Required at baseline an insulin therapy according to national guideline
• Used any other OAD (except metformin)
• Used a single pill combination in addition to the medicine of interest
• Have a severe disease (i.e. cirrhosis, end stage renal disease…)
• Are unlikely to cooperate in the study or to follow the educational program

Sponsors & Collaborators

• Servier Affaires Médicales: lead

Study Sites (1)

Servier Affaires Médicales

Suresnes, 92284, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: November 26, 2024
• Study Start: November 4, 2022
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)