Insulins Glargine And gluLisine strAtegy vs Premixed insulin strAteGy: a cOmparative Study
- Conditions
- Health Condition 1: null- Type 2 Diabetes MellitusHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2010/091/001386
- Lead Sponsor
- Sanofi India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 870
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 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
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Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: <br/ ><br>To demonstrate the superiority of a strategy with insulin glargine in <br/ ><br>comparison with a strategy including the premixed insulin in term of <br/ ><br>percentage of patients reaching HbA1c below 7% at the end of the treatment <br/ ><br>period and who do not experience documented symptomatic hypoglycemia <br/ ><br>(confirmed by a Plasma Glucose (PG) ≤56 mg/dL (3.1 mmol/L)) over the <br/ ><br>treatment period, in Type 2 diabetes patients failing lifestyle management and <br/ ><br>oral agents. <br/ ><br>Timepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method To assess the effect of insulin glargine in comparison with <br/ ><br>premixed insulin on Evolution of HbA1c level during the treatment period <br/ ><br>Timepoint: During the study duration of 24 weeks