Follow-up trial with no study drug prescription in diabetic patients previously included in the REGULATE trial.
- Conditions
- MedDRA version: 14.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]Type II diabetes The medical condition investigated in the REGULATE trial (CL3-00780-148) was type II diabetes. The applied CL3-00780-150 trial, REGULATE follow-up study, is thus performed in diabetic patients.
- Registration Number
- EUCTR2011-001283-22-DE
- Lead Sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 361
Inclusion Criteria
All the patients included in the REGULATE trial (CL3-00780-148) who were exposed to one of the study drugs
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 599
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 246
Exclusion Criteria
Not applicable
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method