TARGET GLYCEMIC CONTROL AND THE INCIDENCE OF DOCUMENTED SYMPTOMATIC HYPOGLYCEMIA IN INSULIN NAÏVE SUBJECTS WITH TYPE 2 DIABETES FAILING ON ORAL HYPOGLYCEMIC AGENT(S) AND TREATED WITH LANTUS (INSULIN GLARGINE) OR LEVEMIR (INSULIN DETEMIR): MULTICENTER, MULTINATIONAL, RANDOMIZED, OPEN-LABEL, COMPARATIVE, PARALLEL-GROUP STUDY - L2T3

Conditions: Type II diabetes mellitus
MedDRA version: 8.1Level: LLTClassification code 10045242

Registration Number: EUCTR2006-000324-13-FI

Lead Sponsor: sanofi-aventis groupe

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 910

Inclusion Criteria

1.Men or women, aged from 40 to 75 years inclusive
2.Type 2 diabetes for at least 1 year
3.Insulin naïve
4.Treated with stable doses of OADs for at least 3 months prior to study start, including at least metformin (at least 1g/day)
5.7% <= HbA1c <=10.5 %
6.Body mass index (BMI) < 40 kg/m2
7.Ability and willingness to perform blood glucose monitoring using a blood glucose meter and to use a patient diary
8.Written informed consent obtained prior to enrollment in the study

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

1.Type 1 diabetes
2.Current or previous use of insulin (except for previous treatment of gestational diabetes or brief treatment with insulin for less than 1 week)
3.Treatment with GLP-1 receptor agonists or with DPP-IV inhibitors
4.Active proliferative diabetic retinopathy, as defined by the application of photocoagulation or surgery, in the 6 months before study entry or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgery during the study (an optic fundus examination should have been performed in the 2 years prior to study entry)
5.Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraceptive method)
6.Breast-feeding
7.History of hypersensitivity to the study drugs or to drugs with a similar chemical structure
8.Treatment with systemic corticosteroids in the 3 months prior to study entry
9.Treatment with any investigational product in the 2 months prior to study entry
10.Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
11.Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
12.Impaired hepatic function as shown by Alamine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) greater than three times the upper limit of normal range at study entry
13.Impaired renal function as shown by serum creatinine >=1.5 mg/dL (>= 133 µmol/L) in men and >= 1.4 mg/dL (124 µmol/L) in women at study entry
14.History of drug or alcohol abuse in the last year
15.Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
16.Patient unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits and unlikelihood of completing the study
17.Patient is the investigator or any sub-investigator, research assistant, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol