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OpenTrials
Completed

NCT Number: NCT06704802

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.

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Servier Affaires Médicales

Suresnes, 92284, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: from baseline to 6-month follow-up

Sponsors and collaborators

Lead sponsor

Servier Affaires Médicales

Industry

Registry information

Acronym: EDUDIA

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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