Type 2 Diabetes
Conditions
Keywords
observational, HbA1c, type 2 diabetes, Diamicron® MR 60, T2D, patient educational program
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.
Interventions
None listed
Sponsors
Servier Affaires Médicales
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed