Trials / Completed
CompletedNCT03703869
Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.
A 12-month Prospective Observational Study Assessing the Real-world Clinical Effectiveness, Safety and Health-economic Benefits of Toujeo® Initiation After Oral Antidiabetic Drug Failure in Insulin-naïve Patients With Type 2 Diabetes Mellitus
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,589 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: Assess effectiveness of insulin glargine (U300) in achieving glycemic goal measured by hemoglobin A1c (HbA1c). Secondary Objectives: * Assess effectiveness in achieving glycemic goal measured by HbA1c; * Assess effectiveness on change in HbA1c, fasting plasma glucose (FPG) and self-monitored plasma glucose (SMPG) ; * Assess requirement for intensification of therapy by additional antidiabetics. * Assess incidence of hypoglycemia; * Assess other safety endpoints: adverse events (AEs), serious adverse events (SAEs); * Assess change in body weight.
Detailed description
Patients will be observed for one year
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Insulin glargine (U300) | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection |
Timeline
- Start date
- 2018-03-06
- Primary completion
- 2019-06-28
- Completion
- 2020-02-24
- First posted
- 2018-10-12
- Last updated
- 2022-04-25
Locations
388 sites across 18 countries: Colombia, Egypt, India, Indonesia, Israel, Jordan, Kuwait, Lebanon, Mexico, Peru, Philippines, Russia, Saudi Arabia, Singapore, Taiwan, Thailand, Ukraine, United Arab Emirates
Source: ClinicalTrials.gov record NCT03703869. Inclusion in this directory is not an endorsement.