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
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT02855684
- Lead Sponsor
- Sanofi
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 604
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Toujeo - insulin glargine (U300) Non-insulin antihyperglycemic drugs Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks Lantus - insulin glargine Insulin glargine Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks Lantus - insulin glargine Non-insulin antihyperglycemic drugs Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks Toujeo - insulin glargine (U300) Insulin glargine (U300) Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks
- Primary Outcome Measures
Name Time Method Change in HbA1c from baseline Baseline, 6 months
- Secondary Outcome Measures
Name Time Method Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L) 6 months Percentage (%) of patients requiring rescue therapy 6 months Change in fasting plasma glucose Baseline, 6 months Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles Baseline, 6 months Change of mean 24-hour plasma glucose Baseline, 6 months Change in variability of plasma glucose profile Baseline, 6 months Change in daily basal insulin dose Baseline, 6 months Percentage (%) of patients with HbA1c <7.0% 6 months Percentage (%) of patients with at least one hypoglycemia Baseline, up to 6 months Percentage (%) of patients with at least one nocturnal hypoglycemia Baseline, up to 6 months Percentage (%) of patients with HbA1c ≤6.5% 6 months Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L) 6 months
Trial Locations
- Locations (54)
Investigational Site Number 1560039
🇨🇳Beijing, China
Investigational Site Number 1560001
🇨🇳Beijing, China
Investigational Site Number 1560017
🇨🇳Beijing, China
Investigational Site Number 1560003
🇨🇳Beijing, China
Investigational Site Number 1560033
🇨🇳Changchun, China
Investigational Site Number 1560016
🇨🇳Changzhou, China
Investigational Site Number 1560049
🇨🇳Changzhou, China
Investigational Site Number 1560006
🇨🇳Fuzhou, China
Investigational Site Number 1560004
🇨🇳Guangzhou, China
Investigational Site Number 1560036
🇨🇳Guangzhou, China
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