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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

NCT03760991 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2022-04-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

INSULIN GLARGINE (U300)

Pharmaceutical form: Solution for injection in a prefilled pen Route of administration: Subcutaneous

Sponsors & Collaborators

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
2018-12-18
Primary Completion
2020-09-23
Completion
2020-09-23

Countries

  • Argentina
  • Colombia
  • Egypt
  • Hong Kong
  • India
  • Indonesia
  • Lebanon
  • Malaysia
  • Peru
  • Philippines
  • Saudi Arabia
  • South Africa
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760991 on ClinicalTrials.gov