Type 1 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: \- To compare the 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state Secondary Objectives: * To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments; * To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c)); * To compare the occurrence of hypoglycemia between the 2 treatments; * To assess the safety and tolerability of a new formulation of insulin glargine.
Detailed description
66 days
Interventions
Pharmaceutical form: solution Route of administration: subcutaneous
DRUGinsulin glargine- new formulation (HOE901)
Pharmaceutical form: solution Route of administration: subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: * Japanese patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin;
Exclusion criteria
* Age \< 20 years at written informed consent; * HbA1c \< 6.5% or \> 10.0% at screening * Diabetes mellitus (DM) other than T1DM; * Body Mass Index (BMI) \> 35.0 kg/m2 at screening visit * Any contraindication to use of insulin glargine as defined in the Japanese Package Insert * Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit 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 24-hour blood glucose profile measured by continuous glucose monitoring | Baseline, Day 28, Day 56 |
Secondary
| Measure | Time frame |
|---|---|
| Hypoglycemia categorized by the definition of American Diabetes Association | Up to Day 56 |
| Change in fasting plasma glucose from baseline to each treatment end by treatment | Baseline, Day 28, Day 56 |
| Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment | Baseline, Day 28, Day 56 |
| Change in HbA1c from baseline to each treatment end by treatment | Baseline, Day 28, Day 56 |
Countries
Japan
Outcome results
None listed