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.

Completed

• Conditions: Type 2 Diabetes

• Registration Number: NCT06704802
• Lead Sponsor: Servier Affaires Médicales

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-04
• Primary Completion: 2024-06-28
• Study Completion: 2024-06-28
• Status Verified: 2024-11
• Study First Submitted: 2024-11-22
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 678

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Servier Affaires Médicales; 🇫🇷 Suresnes, France