Superiority of insulin glargine Lantus vs. NPH: Treat to Normoglycemia concept”.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-naïve People with Type 2 Diabetes Mellitus Treated with at Least One OAD and Not Adequately Controlled. - LANCELOT

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 670

Inclusion Criteria

Inclusion criteria
•Aged from 30 to 70 years inclusively
•Insulin-naïve type 2 diabetes mellitus
•Type 2 diabetes mellitus diagnosed for at least 1 year
•Treated with at least one OAD (Metformin [daily dose of at least 1000mg], Sulfonylurea, glinides or alpha-glucosidase inhibitor) at stable dose for at least 3 months.
•HbA1c > or = 7.0% and < or = 10.5%
•BMI < 40 kg/m2
•Ability and willingness to perform plasma glucose monitoring using the sponsor-provided glucose meter and patient diary at home
•Informed consent obtained in writing at enrolment into the study
•Willingness and ability to comply with the study protocol

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Treatment with GLP-1 agonists or with DPP-IV inhibitors in the 3 months prior to study entry
•Treatment with TZD as monotherapy
•Diabetes mellitus other than Type 2 (e.g. secondary to pancreatic disorders, drugs or chemical agents intake
• Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry)
•Impaired renal function: serum creatinine = 1.5 mg/dL (= 133µmol/L) or = 1.4 mg/dL (= 124 µmol/L) in men and women, respectively
•History of sensitivity to the study drugs or to drugs with a similar chemical structure
•Impaired hepatic function (ALT and/or AST > 3 x upper limit of normal range)
•Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
•Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted.
•Treatment with an investigational product in the 30 days prior to visit 1
•Alcohol or drug abuse in the last year
•Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patient’s safety or limit the patient successful participation in the study (including night shift worker)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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