A observational study assessing the real world data on inititating treatment of Toujeo after oral antidiabetic drug failure in insulin-naive patients with Type 2 Diabetes Mellitus patients.
- Conditions
- Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2018/02/012158
- Lead Sponsor
- Sanofi India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Signed patient informed consent;
2. Type 2 diabetes mellitus;
3. Treated with at least 1 OAD for at least 6 months;
4. Legal age of adulthood, but at least >=18 years;
5. HbA1c >7.0 % and <=11% within 3 months of study baseline;
6. Physiciansâ?? decision in accordance with the current local guidelines to add basal insulin glargine U300 to an existing OAD regimen
1. Diabetes mellitus other than type 2;
2. Existing or previous treatment with insulin or other injectable antidiabetic drugs. The
following is allowed:
- Previous short-term insulin treatment due to an intercurrent medical condition,
with treatment duration not exceeding 10 concurrent days in the past year;
- Previous insulin treatment of gestational diabetes, if the patient has discontinued
insulin treatment more than a year ago.
3. Contraindication to insulin glargine U300 according to local product labelling;
4. Pregnancy, breastfeeding or pregnancy planned during the course of the study;
5. Drug or alcohol abuse within the past year;
6. Concomitant disease with life expectancy of less than 1 year;
7. Concomitant participation in a clinical trial
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method