Trials / Completed
CompletedNCT03760991
Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin
A Multicenter, Multinational, Prospective, Interventional, Single-arm, Phase IV Study Evaluating the Clinical Efficacy and Safety of 26 Weeks of Treatment With Insulin Glargine 300 U/mL (Gla-300) in Patients With Type 2 Diabetes Mellitus Uncontrolled on Basal Insulin
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 372 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Primary Objective: To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal insulin following the switch to Gla-300. Secondary Objectives: To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (HCRU) outcomes. To evaluate the safety of Gla-300.
Detailed description
Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INSULIN GLARGINE (U300) | Pharmaceutical form: Solution for injection in a prefilled pen Route of administration: Subcutaneous |
Timeline
- Start date
- 2018-12-18
- Primary completion
- 2020-09-23
- Completion
- 2020-09-23
- First posted
- 2018-12-03
- Last updated
- 2022-04-25
Locations
14 sites across 14 countries: Argentina, Colombia, Egypt, Hong Kong, India, Indonesia, Lebanon, Malaysia, Peru, Philippines, Saudi Arabia, South Africa, Thailand, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT03760991. Inclusion in this directory is not an endorsement.