Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Insulin Glargine: "
Time: administered once a day in the evening, at the same time every day
Starting daily dose: will be 0.2 U/Kg of body weight or 12 U, at the investigator?s decision
Monitoring of plasma glucose and t
#8804
FPG &
100 mg/dL (4.4 &
5.5 mmol/L) Insulin Glulisine - Insulin glulisine, for patients of the
140 mg/dL (7.8 mmol/L)
"
Control Intervention1: Premixed Premix Insulin: "Time: administered once a day (in the evening at dinner) or twice a d
Sponsors
Sanofi India Limited
Eligibility
Inclusion criteria
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 Body mass index (BMI) 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
Exclusion criteria: Exclusion criteria ? Treatment with 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 ? Alcohol or drug abuse within the last 5 years ? Night shift worker ? Presence of any condition (medical, psychological, social or geographical), current or anticipated that would compromise the patient?s safety or limit the patient successful participation in the study "
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: "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 below 7% at the end of the treatment period and who do not experience documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤56 mg/dL (3.1 mmol/L)) over the treatment period, in Type 2 diabetes patients failing lifestyle management and oral agents." Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of insulin glargine in comparison with premixed insulin on Evolution of HbA1c level during the treatment period Timepoint: During the study duration of 24 weeks | — |
Countries
Austria, Brazil, China, Colombia, Denmark, Greece, India, Italy, Kuwait, Mexico, Republic of Korea, Romania, Spain, Taiwan, Turkey
Contacts
Public ContactDr Deepa Chodankar
Sanofi-Synthelabo (India) Limited
Outcome results
None listed