Evaluation of Toujeo Insulin in Type 2 Diabetes Patients Inadequately Control With Their Basal Insulin Treatment
NCT02967237 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2022-04-25
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
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
insulin glargine (U300)
Pharmaceutical form: solution Route of administration: subcutaneous
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Sciences & Operations · Sanofi
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-04
- Primary Completion
- 2017-07-24
- Completion
- 2017-07-24
Countries
- France
Study Locations
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