Diabetes Mellitus, Type 2
Conditions
Brief summary
Primary Objective: To demonstrate the superiority of a strategy with insulin glargine in comparison with a strategy including the premixed insulin in term of percentage of patients reaching HbA1c (glycosylated hemoglobin) below 7% at the end of treatment and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) below 56 mg/dL (3.1 mmol/L)) over a 24-week treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents. Secondary Objectives: To assess the effect of insulin glargine in comparison with premixed insulin on : * Evolution of HbA1c level during the treatment period Percentage of patients who reach the target of HbA1c \< 7 % and who do not experience documented symptomatic hypoglycemia confirmed by a Plasma Glucose (PG) below 70 mg/dL (3.9 mmol/L) * Percentage of patients who reach the target of HbA1c \< 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 56 mg/dL (3.1 mmol/L) \>Percentage of patients who reach the target of HbA1c \< 6.5% and who do not experience documented symptomatic hypoglycemia confirmed by a PG below 70 mg/dL (3.9 mmol/L) \>Evolution of Fasting Plasma Glucose Evolution of 7-point plasma glucose profiles * Evolution of weight * Hypoglycemia occurrence * Dose of insulins * Evolution of liver function * Overall safety
Interventions
DRUGINSULIN GLARGINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)
DRUGINSULIN GLULISINE
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL)
DRUGPREMIXED INSULIN
Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: - 30% soluble insulin aspart and 70 % protamine-crystallised insulin aspart in pre-filled Flexpen for all the countries except Mexico * 25 % insulin lispro solution and 75% insulin lispro protamine in cartridges for Humapen Luxura for Mexico only
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes diagnosed for more than 1 year * Insulin naïve * Treated with lifestyle interventions and oral antidiabetic drugs, at least metformin at the maximum tolerated dose (with a minimum dose of 1g/day), for at least 3 months * HbA1c ≥ 7.0 % and ≤ 10.5% * Body mass index (BMI) ≤ 40 kg/m2 * Ability and willingness to perform plasma glucose (PG) monitoring using the sponsor-provided glucose meter and to complete the patient diary * Willingness and ability to comply with the study protocol * Signed informed consent obtained prior any study procedure
Exclusion criteria
* Treatment with glucagon-like peptide-1 (GLP-1) agonists in the 3 months prior to study entry * Previous treatment with insulin (except for treatment of gestational diabetes or brief treatment with insulin for less than 1 week) * Diabetes other than type 2 diabetes (e.g. type 1 diabetes, diabetes secondary to pancreatic disorders, drug or chemical agent intake) * Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method) * Hospitalized patient (except for routine diabetes check-up) * Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to study entry, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study, documented by retina examination, in the 2 years prior to study entry * History of sensitivity to the study drugs or to drugs with a similar chemical structure * Impaired renal function: creatinine clearance \< 60ml/min * Impaired liver function (ALT, AST \> 3 x upper limit of normal range) * Severe gastro-intestinal disease * Treatment with corticosteroids with potential systemic action within the 3 months prior to study entry * Likelihood of requiring treatments during the study which are not permitted * Treatment with an investigational product in the 30 days prior to study entry * Alcohol or drug abuse within the last 5 years 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 |
|---|---|
| Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L] | From baseline (visit 2, week 0) to visit 14 (week 24) |
Secondary
| Measure | Time frame |
|---|---|
| 7-point plasma glucose (PG) profile recorded on 3 consecutive days | From baseline (visit 2, week 0) to visit 14 (week 24) |
| Self-monitored PG (Plasma Glucose) values over 3 consecutive days | before visit 4 (week 2) |
| Weight and supine blood pressure | From baseline (visit 2, week 0) to visit 14 (week 24) |
| Insulin doses of the day before each visit | from visit 3 (week 1) to visit 14 (week 24) |
| Biochemistry and lipid profile | From baseline (visit 2, week 0) to visit 14 (week 24) |
Countries
Austria, Brazil, China, Colombia, Denmark, Greece, India, Italy, Kuwait, Mexico, Romania, South Korea, Spain, Taiwan, Turkey (Türkiye), United Arab Emirates
Outcome results
None listed