Trials / Completed
CompletedNCT02967237
Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment
An Interventional, Open-label, Single-arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 136 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: The primary objective is to describe the effect of insulin glargine (U300) in type 2 diabetes mellitus (T2DM) patients uncontrolled with their current basal insulin therapy and eligible for basal switching, according to the Physician decision, on glycated hemoglobin (HbA1c) improvement. Secondary Objectives: * Evolution of fasting plasma glucose * Evolution of insulin dose and body weight * Hypoglycemia incidence * Safety * Patients satisfaction when they change their insulin for HOE901-U300
Detailed description
The total study duration per patient is approximately 28 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | insulin glargine (U300) | Pharmaceutical form: solution Route of administration: subcutaneous |
Timeline
- Start date
- 2016-01-04
- Primary completion
- 2017-07-24
- Completion
- 2017-07-24
- First posted
- 2016-11-18
- Last updated
- 2022-04-25
Locations
85 sites across 1 country: France
Source: ClinicalTrials.gov record NCT02967237. Inclusion in this directory is not an endorsement.