NCT02855684

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

6-Month, Multicenter, Randomized, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 2-day post-treatment safety follow-up period.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-08-24
• Primary completion: 2018-08-06
• Completion: 2018-08-06
• First posted: 2016-08-04
• Last updated: 2022-04-25

Locations

54 sites across 3 countries: China, South Korea, Taiwan