Type 2 Diabetes Mellitus
Conditions
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.
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGInsulin glargine
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGNon-insulin antihyperglycemic drugs
Pharmaceutical form: capsule/tablet Route of administration: oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s). * Signed written informed consent.
Exclusion criteria
* Age \< legal age of adulthood. * HbA1c \<7.0% (\<53 mmol/mol) or \>11% (\>97 mmol/mol) (at screening). * History of type 2 diabetes mellitus for less than 1 year before screening. * Less than 6 months before screening with non-insulin antihyperglycemic treatment. * Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening. * Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of glucagon like peptide-1(GLP-1) receptor agonist in the last 6 months before screening visit. * Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin are to be discontinued at randomization). * Current or previous insulin use except for a maximum of 10 consecutive days (eg, acute illness, surgery) during the last one year prior to screening. * Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. * Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c from baseline | Baseline, 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L) | 6 months |
| 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 |
| Percentage (%) of patients with HbA1c ≤6.5% | 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 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 <7.0% | 6 months |
| Change of mean 24-hour plasma glucose | Baseline, 6 months |
Countries
China, South Korea, Taiwan
Outcome results
None listed