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Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy

NCT02855684 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2022-04-25

No results posted yet for this study

Summary

Primary Objective:

To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes mellitus.

Secondary Objectives:

* To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia.
* To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia).
* To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia).
* To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative).
* To assess the safety and tolerability of insulin glargine (U300).
* To assess the development of anti-insulin glargine antibodies (AIA).

Conditions

Interventions

DRUG

Insulin glargine (U300)

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Insulin glargine

Pharmaceutical form: solution Route of administration: subcutaneous

DRUG

Non-insulin antihyperglycemic drugs

Pharmaceutical form: capsule/tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-24
Primary Completion
2018-08-06
Completion
2018-08-06

Countries

  • China
  • South Korea
  • Taiwan

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 NCT02855684 on ClinicalTrials.gov