NCT06704802Completed
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.
Source: ClinicalTrials.gov · Last updated 26 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 678 (actual)
- First submitted
- 22 Nov 2024
- Start date
- Nov 2022
- Primary completion date
- Jun 2024
- Lead sponsor
- Servier Affaires Médicales
- Diseases
- Type 2 diabetes
- NCT number
- NCT06704802
What you commit to
- Study type: Observational
- Participants enrolled: 678
- From Nov 2022 to the primary completion date, Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who previously attended to the NDT educational program for T2D management
- Required at baseline an insulin therapy according to national guideline
Other illness
- Diagnosis of diabetes other than T2D
- Have a severe disease (i.e. cirrhosis, end stage renal disease…)
Lab values
- HbA1c value not available at baseline
Other
- Used any other OAD (except metformin)
- Used a single pill combination in addition to the medicine of interest
- Are unlikely to cooperate in the study or to follow the educational program
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Servier Affaires Médicales Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.