Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

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 ≤ 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.